QUIKSTRIP ONE STEP BENZODIAZEPINE TEST by DRIAL CONSULTANTS, INC.

Syntron's QuikStrip One Step Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 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 indicated. Syntron's QuikStrip One Step Benzodiazepine Test is not intended to monitor drug levels, but only to screen urines for the presence of Benzodiazepine and its metabolites:

Device Description

Syntron's QuikStrip One Step Benzodiazepine 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 200 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

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The submission does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets). Instead, it presents the device's performance metrics from an internal study and a clinical trial. However, the FDA's acceptance of the 510(k) submission implies that these reported performances were deemed sufficient for substantial equivalence.",
    "Reported Device Performance (Internal Testing)": {
      "Relative Sensitivity (agreement within positive samples)": "1.000 (100%)",
      "Relative Specificity (agreement within negative samples)": "0.9740 (97.40%)",
      "Accuracy": "98.54%"
    },
    "Reported Device Performance (Clinical Trial)": {
      "Relative Sensitivity": "100%",
      "Relative Specificity": "95.42%",
      "Accuracy": "97.69%"
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Test Set Sample Size": "303 samples (for the clinical trial)",
    "Data Provenance": "The document does not specify the country of origin of the data. It mentions 'Clinical Trial' which typically implies prospective data collection, even if the samples themselves might be collected over time. No explicit statement about retrospective or prospective is given for the 303 samples, but 'clinical trial' strongly suggests prospective."
  },
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "The ground truth for the test set was established using Gas Chromatography/Mass Spectrophotometry (GC/MS) for all positive samples from either screening method. GC/MS is a laboratory analytical technique and typically does not involve 'experts' in the same way as medical imaging interpretation. The document does not specify the number or qualifications of personnel operating the GC/MS or interpreting its results, assuming standard laboratory protocols.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable in the conventional sense for this type of test. The ground truth (presence/absence of benzodiazepines above a certain cutoff) was determined by GC/MS, an objective analytical method. There's no indication of multiple readers or an adjudication process for the GC/MS results themselves.",
  "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": "Not applicable. This is a standalone diagnostic test (QuikStrip) and not an AI-assisted interpretation tool for human readers. There is no mention of a human-in-the-loop component or a MRMC study.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, standalone performance was done. The QuikStrip One Step Benzodiazepine Test is a qualitative immunoassay designed to provide a direct visual result (presence or absence of a color band) without human interpretation beyond reading the band. The presented sensitivity, specificity, and accuracy are for the device's performance on its own.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth was established by Gas Chromatography/Mass Spectrophotometry (GC/MS). This is an objective analytical method considered the 'gold standard' for confirming the presence and concentration of drugs and their metabolites.",
  "8. The sample size for the training set": "The document does not explicitly state a 'training set' sample size. It refers to 'in-house testing' and a 'clinical trial'. For the performance evaluation, 303 samples were used in the clinical trial. The device mechanism (competitive binding immunoassay) is not typically 'trained' in the same way a machine learning algorithm is.",
  "9. How the ground truth for the training set was established": "As there is no explicitly defined 'training set' for a machine learning model, this question is not directly applicable. For the samples used in the performance evaluation (in-house and clinical trial), the ground truth for benzodiazepine presence and concentration was established by GC/MS."
}

Summary

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FEB 2 5 1998

510k Submission for

QuikStrip One Step Benzodiazepine Test

Syntron Bioresearch, Inc.

Page 77 of 77

K973269

Revision A 8/18/97 Printed on 8/26/97

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 Benzodiazepine and its metabolites in a screening format.

The trade name of the device is QuikStrip One Step Benzodiazepine Test having a designated common name of Benzodiazepine Test System and a classification as a Class II device per 21 CFR ¶ 862.3170. This device is intended for the medical/forensic screening of urine.

In-house testing of Syntron's QuikStrip One Step Benzodiazepine Test vielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of .9740 and an accuracy of 98.54% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 303 samples was run and the combined data vielded a relative sensitivity of 100%, a relative specificity of 95.42% with an accuracy of 97.69% when compared to Emit II® run at 200 ng/ml. By non parametric testing the results are significantly different from one another. Emit II vielded 7 false positives. GC/MS results indicated the presence of drugs, but at a level below the cutoff of 200 ng/ml.

. All positive samples by either screening method were confirmed by GCMS. The testing performed by both the sponsor and the Clinical Trial site did find 2 and 7 respectively false positives and no false negatives in the samples tested. GC/MS confirmed the presence of benzodiazenines but at levels below the cutoff of 200 ng/ml.

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 logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized eagle symbol, which is a common emblem associated with the United States.

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 Simi Valley, California 93065

FEB 25 1998

Re : K973269 QuikStrip One Step Benzodiazepine Test Requlatory Class: II Product Code: JXM Dated: January 15, 1998 Received: January 16, 1998

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 regulations.

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

Sincerely yours,
Steven Litman

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): Has Yet to be assigned

Device Name: Syntron's QuikStrip One Step Benzodiazepine assay

Indications For Use:

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

Concurance of CDRH, Office of Device Evaluation (ODE)

Perscription Use: (Per 21 CFR 801.109 or

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

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K973269

Regulation Number and Section

§ 862.3170 Benzodiazepine test system.

(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).