QUIKSTRIP ONE STEP BARBITURATE TEST by SYNTRON BIORESEARCH, INC.

Syntron's QuikStrip One Step Barbiturate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturate 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 Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.

Device Description

Syntron's QuikStrip One Step Barbiturate 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. Table of Acceptance Criteria and Reported Device Performance:

Metric	Acceptance Criteria (Implied by Predicate)	QuikStrip Performance (Clinical Trial)
Relative Sensitivity	Not explicitly stated, but 100% by in-house	100%
Relative Specificity	Not explicitly stated, but 100% by in-house	99.41%
Accuracy	Not explicitly stated, but 100% by in-house	99.61%
False Positives	Minimize, ideally 0	2 (due to adulterant)
False Negatives	Minimize, ideally 0	0

Note: The document implies acceptance criteria by comparing the device's performance to the predicate device (Syva EMIT® /200 II) and stating that the results are not significantly different. The in-house testing results, which also achieved 100% for sensitivity, specificity, and accuracy against GC/MS-confirmed samples, further suggest this as a benchmark.

2. Sample Size and Data Provenance:

Clinical Trial Test Set Sample Size: 307 samples.
Data Provenance: The document does not explicitly state the country of origin. It refers to "in-house testing" by the sponsor (Syntron Bioresearch, Inc. in Carlsbad, California) and a "clinical trial site." This suggests US-based data, but it is not definitively stated.
Retrospective or Prospective: Not explicitly stated, but given the nature of a "clinical trial," it is more likely to be prospective for the 307 samples. The "in-house testing" against samples documented as positive by GC/MS could be retrospective analysis of already collected samples.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts or their qualifications for establishing ground truth, beyond using "GC/MS" as the definitive confirmation method.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. The direct comparison is made against GC/MS (200 ng/ml) for all positive samples. This implies GC/MS served as the definitive arbiter.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a "QuikStrip One Step Barbiturate Test," which is a rapid, qualitative immunoassay. It does not involve human readers interpreting complex images or data in a way that an MRMC study would typically assess.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The described "in-house testing" and "clinical trial" directly assess the performance of the QuikStrip device itself (relative sensitivity, relative specificity, accuracy) against a reference standard (Syva EMIT® /200 II and GC/MS). The device provides a visual result (color band) and does not require complex human interpretation that would necessitate a "human-in-the-loop" assessment for primary validation.

7. Type of Ground Truth Used:

The primary ground truth used for confirmation, especially for positive samples, was Gas Chromatography/Mass Spectrometry (GC/MS) at a cutoff of 200 ng/ml.
The device's performance was also compared against the Syva EMIT® /200 II as a predicate device, which itself is a screening method.

8. Sample Size for the Training Set:

The document does not provide information on a specific training set sample size. This is a rapid diagnostic test, and the development process might involve internal calibration and development-phase testing rather than a distinct, formal "training set" like in machine learning models.

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

As no specific "training set" is mentioned, the method for establishing its ground truth is not described. However, it's reasonable to infer that during the development of the immunoassay, internal validation and optimization would rely on similarly established ground truth using methods like GC/MS to ensure the test accurately detects barbiturates at the specified cutoff.

Summary

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K974712

510k Submission for

QuikStrip One Step Barbiturate Test

Syntron Bioresearch, Inc.

FEB | 2 |998 Page 25 of 68

Revision A 8/18/97 Printed on 12/12/97

SUMMARY OF SAFETY AND EFFECTIVENESS 8.

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 Barbiturate and its metabolites in a screening format.

The trade name of the device is QuikStrip One Step Barbiturate Test having a designated common name of Barbiturate Test System and a classification as a Class II device per 21 CFR 9 862.3150. This device is intended for the medical/forensic screening of urine.

In-house testing of Syntron's QuikStrip One Step Barbiturate Test yielded 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 tested against Syva EMIT® /200 II on samples documented to be positive by GC/MS. A clinical trial consisting of 307 samples was run and the combined data vielded a relative sensitivity of 100%, a relative specificity of 99.41% with an accuracy of 99.61% when compared to Emit II® run at 200 ng/ml. By non parametric testing the results are not significantly different from one another. QuikStrip vielded 2 false positives due to the presence of an adulterant "Clean Jane" (sodium dodecylsulfate [Tide]).

All positive samples by either screening method were confirmed by GC/MS (200 neml) . The testing performed by both the sponsor and the Clinical Trial site did find 2 false positives and no false negatives in the samples tested. The False Positive was due to the presence of "Clean Jane" (sodium dodecylsulfate (Tidel). GC/MS confirmed the presence of sodium dodecylsulfate [Tide].

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.

Proprietary Information Confidential

Do Not Copy

Proprietary Information Confidential

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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" around the perimeter. Inside the circle is an abstract image of a human figure, represented by three curved lines that suggest a head, body, and legs.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 2 1998

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

K974712 Re: QuikStrip One Step Barbiturate Test Regulatory Class: II Product Code: DIS December 15, 1997 Dated: December 16, 1997 Received:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 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 regulatory In addition, FDA may publish further announcements action. 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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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 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 Sitman

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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K974712

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

Device Name: QuikStrip One Step Barbiturate Test

Indications For Use:

Syntron's QuikStrip One Step Barbiturate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturate 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 indicated6. Syntron's QuikStrip One Step Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.

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

Concurance of CDRH, Office of Device Evaluation (ODE)

Teuaiki for ae Montgomery
(Division Sign-Off)

Division of Clinical Laboratory Devices K974 510(k) Number .

Perscription Use:
(Per 21 CFR 801.109

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

Regulation Number and Section

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).