QUIKPAC II ONE STEP COCAINE TEST by DRIAL CONSULTANTS, INC.

Syntron's QuikPac II One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the cutoff level of 150 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Cocaine Test is not intended to monitor drug levels, but only to screen urines for the presence of Cocaine and its metabolites.

Device Description

Syntron's QuikPac II One Step Cocaine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 150 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the QuikPac II One Step Cocaine Test based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, and accuracy. Instead, it presents the calculated performance against a commercial EIA test, with GC/MS confirmation for positive samples. We can infer that the reported values met the internal standards for the device to be submitted.

Metric	Acceptance Criteria (Inferred)	Reported Device Performance (Clinical Trial)
Sensitivity	High agreement with EIA	99.49%
Specificity	High agreement with EIA	100%
Accuracy	High overall agreement with EIA	99.75%

Note: The document also mentions "In-house testing" results (sensitivity 1.000, specificity 0.9839, accuracy 99.03%) when tested against a commercial EIA and "samples documented to be positive by GC/MS." However, the clinical trial data are generally considered more robust for regulatory submission, so the clinical trial results are presented here.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 304 samples
Data Provenance: Not explicitly stated, but the submission is from Syntron Bioresearch, Inc. in Carlsbad, California, suggesting the study was conducted in the United States. The study is a prospective clinical trial as distinct from "in-house testing".

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth was established by comparison to a commercial EIA test, with positive results confirmed by GC/MS. This suggests the experts involved were likely laboratory personnel or clinicians interpreting the results of these established methods.

4. Adjudication Method (for the test set)

Adjudication Method: The primary comparison was against a commercial EIA test. For all positive samples by either screening method (QuikPac II or EIA), confirmation was done by GC/MS. This acts as a definitive adjudicator for positive results. For negative results where both screening methods agreed, no further adjudication (like GC/MS) is mentioned, implying agreement between the two screening methods was sufficient for negative calls.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This device is a rapid diagnostic test, not an imaging analysis device where multiple human readers would typically be involved in interpreting the output in the same way. The performance is assessed based on the device's output compared to a reference method.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone study was done. The clinical trial explicitly measures the performance of the "QuikPac II One Step Cocaine Test" itself in detecting cocaine and its metabolites in urine, comparing its results directly to established reference methods (commercial EIA and GC/MS). This is a standalone performance assessment.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for positive samples was established by gas chromatography/mass spectrophotometry (GC/MS), which is a highly accurate and definitive method for drug identification and quantification. For negative samples, the agreement of a commercial EIA test with the QuikPac II test served as an initial ground truth, implicitly supported by the absence of GC/MS confirmation if both were negative.

8. The Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated in the provided text. The document focuses on the performance of the device in a clinical trial, which typically uses a separate, independent test set. In-house testing is mentioned, which may have contributed to development and refinement, but no specific number or details about a formal training set are given.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not explicitly stated. Given the "in-house testing" mention, it's reasonable to infer that similar methods (commercial EIA and GC/MS) were used to establish ground truth during the development and optimization phases, but no specific details are provided.

Summary

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AUG 28 1997

510k Submission for QuikPac II One Step Cocaine Test

Syntron Bioresearch, Inc.

Page 80 of 80 Pages

K972050

Revision d 5/17/97, 7/26/97 Printed on 8/11/97

Summary of Safety and Effectiveness

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlsbad, California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Cocaine and its metabolites in a screening format.

The trade name of the device is QuikPac II One Step Cocaine Test having a designated common name of Cocaine Test System and a classification as a Class II device per 21 CFR 9 862.3250. This device is intended for the medical/forensic screening of urine.

In-house testing of Syntron's QuikPac II One Step Cocaine Test vielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 0.9839 and an accuracy of 99.03% when tested against a commercial EIA test for Coacaine on samples documented to be positive by GC/MS. A clinical trial consisting of 304 samples was run and the combined data yielded a relative sensitivity of 99.49%, a relative specificity of 100% with an accuracy of 99.75% when compared to a commercial EIA test for Coacaine.

All positive samples by either screening method were confirmed by GC/MS. The results on the 3 discrepant samples clearly demonstrated similar errors by both methods. Three samples were positive by both Emit II® and QuikPac II, but negative for Cocaine by GC/MS. All three samples were demonstrated to be adulterated with "Clean Jane" [sodium dodecylsulfate (Tide)] which is supposed to interfere with positive testing, but causes both screening tests to return positive results. GCMS analysis will return a negative for the drug, but a positive for the adulterant.

Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings forming a human profile. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration ¨¨ 2098 Gaither Road Rockville MD 20850

Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue Suite 201 Stmi Valley, California 93065

AUG 28 1997

K972059/S1 Re: QuikPac II One Step Cocaine Assay Trade Name: Requlatory Class: II Product Code: DIO Dated: Auqust 11, 1997 Received: August 12, 1997

Dear Dr. Laird:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in_vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if Known): Not yet assigned

Device Name: QuikPac II One Step Cocaine assay

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)

(Division Sign-Off) wision of Clinical Labor. (k) Number Perscription Use: Over The Counter Use: or (Per 21 CFR 801.109 (Optional Format 1-2-96)

Concurance of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).