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FEB 1.7 Z004, 8. 510(k) SUMMARY '. This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The Assigned 510(k) number is b D. Submitter: ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121 Tel.: 858-535-2030 Fax: 858-535-2038 Date: September 22, 2003 Contact Person: Edward Tung, Ph.D. Product Names: ACON® OXY One Step Oxycodone Test Strip ACON® OXY One Step Oxycodone Test Device Common Name: Immunochromatographic test for the qualitative detection of Oxycodone in urine. Regulation Name: Opiates test system. Product Code: DJG 36

FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

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Official FDA 510k Clearance Certification OXY K033047. More on www.EmployeeDrugTestingAce.com/Library and Product Pages. Aka: www.EDTAce.com. Oxycodone (OXY) is used to relieve moderate to moderate-to-severe pain. It also is used to relieve postpartum, postoperative, and dental pain. Oxycodone comes as a liquid and tablet to take by mouth and can be habit forming. Trade Names: Dazidox, Eth-Oxydose, Endocet, Endocodone, M-Oxy, Oxycontin, OxyContin, Oxyir, Oxyfast, Percolone, Roxicet, Roxicodone, Roxicodone Intensol, Percocet, Percodan, Tylox. Street Names: Blue, Hillbilly Heroin, Killers, Oc, Ox, Oxy,... DOA-167-321-019, DOA-1124-011T, I-DOA-1137-011, DOA-1105-051, I-DUE-1127-022, DCB-1115-011, DOA-184-271T, I-DUE-187-071, I-DUE-1107-141, I-DUE-167-342, I-DOA-1107-051, I-DUA-167-291, DOA-164-551, I-DOA-194-191, DOA-1127-041-019, DOX-102, DOX-114, I-DOX-102, IS1 OXY

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Page 1: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

FEB 1.7 Z004,

8. 510(k) SUMMARY '.

This summary of safety and effectiveness information is being submitted in accordance with therequirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) number is b D.

Submitter:

ACON Laboratories, Inc.4108 Sorrento Valley BoulevardSan Diego, California 92121

Tel.: 858-535-2030Fax: 858-535-2038

Date:

September 22, 2003

Contact Person:

Edward Tung, Ph.D.

Product Names:

ACON® OXY One Step Oxycodone Test StripACON® OXY One Step Oxycodone Test Device

Common Name:

Immunochromatographic test for the qualitative detection of Oxycodone in urine.

Regulation Name:

Opiates test system.

Product Code:

DJG

36

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Oxycodone Employee Drug Testing Kits

Page 2: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

Classification Number:

21 CFR, 862.3650

Device Classification:

The Oxycodone test systems have been classified as Class II devices with moderate complexity.The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone TestDevice are similar to another FDA-cleared device for the qualitative detection of Oxycodone inurine specimens. These tests are used to provide only a preliminary analytical result. All positivetest results obtained with these devices must be confirmed by another test method, preferablyGC/MS analysis.

Intended Use:

The ACON® OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone TestDevice are rapid chromatographic immunoassays for the qualitative detection of Oxycodone inurine at a cutoff concentration of 100 ng/mL. These tests are used to provide only a preliminaryanalytical result. All positive test results obtained with these devices must be confirmed byanother test method, preferably GC/MS analysis. They are intended for healthcare professionalsincluding professionals at point-of-care sites.

Description:

The ACON OXY One Step Oxycodone Test Strip and ACON OXY One Step Oxycodone TestDevice are competitive binding, lateral flow immunochromatographic assays for the qualitativescreening of Oxycodone in a urine sample. The test is based on the principle of antigen-antibodyimmunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels ofOxycodone and its metabolite in urine at a cutoff concentration of 100 ng/mL. These tests can beperformed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region, while anegative urine specimen or a urine specimen containing Oxycodone at the concentration below thecutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has beenadded and membrane wicking has occurred.

Comparison to a Predicate Device:

A comparison of the features of the ACON OXY One Step Oxycodone Test Strip and ACON OXYOne Step Oxycodone Test Device versus a FDA-cleared Oxycodone test with 100 ng/mL Oxycodonecutoff is shown below:

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Page 3: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

* Both tests are assays intended for the qualitative detection of Oxycodone in urine samples.* Both tests are intended as a screening method that provides a preliminary analytical test

result.* Both tests are immunochromatographic, lateral flow assays for the rapid detection of

Oxycodone with a visual, qualitative end result.* Both tests utilize the same basic immunoassay principles that rely on antigen/ antibody

interactions to indicate a positive or negative result.Both tests have a cutoff Oxycodone concentration of 100 ng/mL.

Safety and Effectiveness Data:

Accuracy

A clinical evaluation was conducted using 300 clinical urine specimens includingapproximately 10% of the specimens containing Oxycodone concentration fell between -25%cutoff to +25% cutoff range. This evaluation compared the test results between ACON® OXYOne Step Oxycodone Test Strip and ACON® OXY One Step Oxycodone Test Device with aFDA-cleared Oxycodone test; as well as compared against data obtained from the customaryGas Chromatography/Mass Spectrometry analysis. These comparisons of data yielded thefollowing results:

ACON OXY One Step Oxycodone Test Strip versus FDA-cleared Oxycodone Test:

Positive Agreement: 142 / 146 = 97% (93 % - 99 %*)Negative Agreement: 154 / 154 = 100% (98 % - 100%**)Overall Agreement: 296 / 300 = 99% (97 % - 99 %*)

* 95% confidence intervals** Since the proportion can not go above 100%, this is really a 97.5% confidence interval

ACON OXY One Step Oxycodone Test Device versus FDA-cleared Oxycodone Test:

Positive Agreement: 142 / 146 = 97% (93 % - 99 %*)Negative Agreement: 154 / 154 = 100% (98 % - 100 %**)Overall Agreement: 296 / 300 = 99% (97 % - 99 %*)* 95% confidence intervals** Since the proportion can not go above 100%, this is really a 97.5% confidence interval

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Page 4: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

ACON OXY One Step Oxycodone Test Strip versus data obtained with GC/MS at thecutoff concentration of 100 ng/mL:

Specimen Cut off Range by GCUMS Data % Agreement withNegative <-25% -25% to Cutoff to > +25% GC/MS Data

Cutoff Cutoff +25% CutoffACON Positive 0 1 4 2 135 96%

OXY Test (92% - 98%)*Strip Negative 147 2 6 1 2 98%

_ (95% - 99* Denotes 95% Confidence Interval.

ACON OXY One Step Oxycodone Test Device versus data obtained with GC/MS at thecutoff concentration of 100 ng/mL

Specimen Cutoff Range by GC/MS Data % Agreement withNegative <-25% -25% to Cutoff to > +25% GCfMS Data

Cutoff Cutoff +25% CutoffACON Positive 0 1 4 2 135 96%

OXY Test (92% - 98%)*Device Negative 147 2 6 1 2 98%

(95% - 99%)** Denotes 95% Confidence Interval.

Performance Characteristics and Other information:

The performance characteristics of ACON OXY One Step Oxycodone Test Strip, ACONOXY One Step Oxycodone Test Device were verified by analytical sensitivity study,specificity and cross reactivity study, interference studies, precision study, read time flexstudy, temperature flex study, specimen storage and stability study. Study results indicate thatthese test devices are robust and can perform satisfactorily when used according to the"Indication for Use" statement specified in their package inserts.

Conclusion:

These clinical studies demonstrated substantial equivalency on performance between theACON OXY One Step Oxycodone Test Strip, ACON OXY One Step Oxycodone TestDevice and a FDA-cleared Oxycodone test with the same Oxycodone cutoff concentration. Itis also demonstrated that these tests are safe and effective in qualitatively detectingOxycodone at a concentration of 100 ng/mL. The POL study demonstrated that these tests aresuitable for healthcare professionals including professionals at point-of-care sites.

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Page 5: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration2098 Gaither Road

FEIB 1 7 2004- Rockville MD 20850

Edward Tung, Ph.D.Regulatory AffairsACON Laboratories, Inc.4108 Sorrento Valley Blvd.San Diego, CA 92121

Re: k033047Trade/Device Name: ACON® OXY One Step Oxycodone Test Strip

ACONO OXY One Step Oxycodone Test DeviceRegulation Number: 21 CFR 862.3650Regulation Name: Opiates test systemRegulatory Class: Class IIProduct Code: DJGDated: December 12, 2003Received: December 18, 2003

Dear Dr. Tung:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDAmay publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practicerequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 6: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.

If you desire specific information about the application of labeling requirements to your device,or questions on the promotion and advertising of your device, please contact the Office ofIn Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note theregulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 443-6597 or at its Internet addresshttp://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

3%an M. Cooper, MS, D.V.M.DirectorDivision of Chemistry and ToxicologyOffice of In Vitro Diagnostic Device

Evaluation and SafetyCenter for Devices and

Radiological Health

Enclosure

Page 7: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

11. INDICATIONS FOR USE

510(k) Number: 1< '30aO/L7

Device Name: ACON® OXY One Step Oxycodone Test Strip

ACON® OXY One Step Oxycodone Test Device

Indications for Use:

The ACON OXY One Step Oxycodone Test Strip and ACON OXY One StepOxycodone Test Device are rapid chromatographic immunoassays for thequalitative detection of Oxycodone levels in urine at a designated cutoffconcentration of 100 ng/mL. They are intended for healthcare professionalsincluding professionals at point-of-care sites.

I

Division Sign-Off ~/

Office of In Vitro Diagnostic DeviceEvaluation and Safety

510(k) -- 0 ( -6& /7

(Please do not write below this point)Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ Or Over-The-Counter Use

(Per 21 CFR 801.109)

42

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Page 8: FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

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