Syntron's QuikStrip One Step Cocaine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cocaine in urine at the NIDA recommended cutoff of 300 ng/ml by GC/MS. (NIDA screening cutoff is 300 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 indicatedf. Syntron's QuikStrip 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 QuikStrip 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 up 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 300 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 an analysis of the provided text regarding the QuikStrip One Step Cocaine Test, structured to address your request:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Clinical Trial)	Reported Device Performance (In-house)
Relative Sensitivity	High (e.g., ≥ 99% for positives)	99.89%	1.000 (100%)
Relative Specificity	High (e.g., ≥ 99% for negatives)	100%	1.000 (100%)
Accuracy	High (e.g., ≥ 99%)	99.56%	100%

Note: The document does not explicitly state acceptance criteria as numerical thresholds. However, the high performance metrics (near 100%) demonstrated in both in-house and clinical trials strongly imply that high accuracy, sensitivity, and specificity were the desired acceptance criteria for this screening device. The comparison against a gold standard (GC/MS) further reinforces this.

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

Sample Size for Clinical Trial Test Set: 318 samples.
Data Provenance: Not explicitly stated (e.g., country of origin). The study is referred to as a "clinical trial," implying it's prospective, but this isn't explicitly stated either. The "in-house testing" would likely be retrospective or controlled laboratory settings.

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

This information is not provided in the document. The ground truth method (GC/MS) is mentioned, but not the number or qualifications of experts interpreting or validating those GC/MS results, or any subsequent adjudication.

4. Adjudication Method for the Test Set

This information is not provided in the document. The text states: "All positive samples by either screening method were confirmed by GC/MS." and "The results on the 2 discrepant samples clearly demonstrated similar errors by the Emitt II method. Two samples were positive by both GC/MS and QuikStrip, but negative for Cocaine by Emit II®." This indicates comparison to a gold standard and analysis of discrepent results, but not a formal adjudication process involving multiple human readers for consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a rapid, qualitative immunoassay for chemical detection, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, a standalone performance evaluation was done. The QuikStrip One Step Cocaine Test is itself a standalone device that provides a qualitative result (presence or absence of a color band, indicating positive or negative for cocaine). Its performance (sensitivity, specificity, accuracy) was measured directly against a gold standard (GC/MS) or a predicate device (Syva EMIT® II), indicating a standalone assessment of its output. There isn't a "human-in-the-loop" interpretation for the device itself; it produces a visual result.

7. The Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "compared against Syva EMIT® II on samples documented to be positive by GC/MS" and "All positive samples by either screening method were confirmed by GC/MS." GC/MS is considered a definitive confirmatory method for drug concentration.

8. The Sample Size for the Training Set

The document does not provide any information about a specific training set or its size. This device is a chemical immunoassay, not a machine learning model, so the concept of a "training set" in the context of AI/ML is not directly applicable. The "in-house testing" likely served a developmental and validation purpose, but a distinct "training set" as understood in AI is not mentioned.

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

As there's no mention of a traditional "training set" for an AI/ML model, this question is not applicable in the context of this device. The development process would have involved internal validation and optimization against known samples, likely with GC/MS confirmation, but this isn't presented as a distinct "training set" with established ground truth in the way a machine learning model would have.

Summary

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K99207

510k Submission for QuikStrip One Step Cocaine(300) Test

Syntron Bioresearch, Inc.

Page 101 of 101

Revision A 05/19/1999 Printed on 05/28/1999

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

In-house testing of Syntron's QuikStrip 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 1.000 and an accuracy of 100% when compared against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 318 samples was run and the combined data yielded a relative sensitivity of 99.89%, a relative specificity of 100% with an accuracy of 99.56% when compared to Emit II®.

All positive samples by either screening method were confirmed by GC/MS. The results on the 2 discrepant samples clearly demonstrated similar errors by the Emitt II method. Two samples were positive by both GC/MS and QuikStrip, but negative for Cocaine by Emit II®.

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 22 1999

Syntron Bioresearch, Inc. c/o Mr. James M. Barquest California Department of Health Services Food & Drug Branch 601 N. Seventh Street P.O. Box 942732, MS-357 Sacramento, California 94234-7320

Re: K992207

Trade Name: OuikStrip One Step Cocaine Assay Regulatory Class: II Product Code: DIO Dated: June 29, 1999 Received: June 30, 1999

Dear Mr. Barquest:

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 legally marketed predicate 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 regulations 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 requirements, as set forth in the Quality System Regulation (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 regulatory 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 Flectronic Product

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Page 2

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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Sutman

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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FOOD & DRUG BRANCH JUN 0 9 1999

510(k) Number (if Known): To be assigned

Device Name: QuikStrip One Step Cocaine

Indications For Use:

INTENDED USE

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

: ・

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dran Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992207

Prescription Use:
(Per 21 CFR 801.109)

Over The Counter Use: (Optional Format 1-2-96)

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).