Syntron's QuikPac II 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 QuikPac II 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 QuikPac II 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 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

Here's a breakdown of the acceptance criteria and study details for the QuikPac II One Step Barbiturate Test:

1. Acceptance Criteria and Reported Device Performance:

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Clinical Trial)
Relative Sensitivity	High (Close to 100%)	100%
Relative Specificity	High (Close to 100%)	99.41%
Accuracy	High (Close to 100%)	99.61%

The document states "By non parametric testing the results are not significantly different from one another," suggesting that the performance against the predicate device (Emit II®) was considered acceptable.

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

Sample Size: 307 samples
Data Provenance: Not explicitly stated, but implies a clinical trial setting. The document mentions "A clinical trial consisting of 307 samples was run," suggesting prospective data collection. The country of origin is not specified.

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

Number of Experts: Not explicitly stated how many experts were involved. The ground truth was established by instrumental analysis (GC/MS).
Qualifications: Not applicable for establishing ground truth as it was based on GC/MS.

4. Adjudication Method for the Test Set:

Adjudication Method: Not explicitly stated as a formal adjudication process. The primary comparator was Syva EMIT® (200) II, with all positive samples by either screening method (QuikPac II or EMIT II®) then confirmed by GC/MS (200 ng/ml). This acts as a confirmatory "adjudication" for positive results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a qualitative diagnostic test that provides a visual readout (color band), not an imaging-based interpretation requiring multiple human readers.

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

Yes, this study is inherently a standalone performance evaluation of the device. The QuikPac II test is designed to provide a direct readout without human interpretation beyond observing the presence or absence of a color band, and then comparing that result to other methods. The performance metrics (sensitivity, specificity, accuracy) are for the device itself.

7. The Type of Ground Truth Used:

Type of Ground Truth: Gold standard instrumental analysis: Gas Chromatography/Mass Spectrophotometry (GC/MS) at a cutoff of 200 ng/ml.

8. The Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" or its size. In-house testing was performed, but the number of samples in this phase is not specified. For this type of diagnostic device, development often involves internal validation rather than distinct "training" and "test" sets in the machine learning sense. The 307 samples represent the clinical trial/test set.

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

As a distinct training set is not explicitly mentioned, the method for establishing ground truth for any in-house testing (development/validation) would likely be similar to the clinical trial: comparison against a reference method (Syva EMIT®) and confirmation of true positives by GC/MS.

Summary

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KY80349

510k Submission for QuikPac II One Step Barbiturates Test

Syntron Bioresearch, Inc. MAR – 3 |998 Page 73 of 73 Pages
Revision A 12/28/97 Printed on 1/26/98

Revision A 12/28/97 Printed on 1/26/98

R - 3 1998 Page 73 of 73 Pages

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 Barbiturate and its metabolites in a screening format.

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

In-house testing of Syntron's QuikPac II 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 yielded 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. QuikPac II yielded 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 ng/ml) . 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 positives were due to the presence of "Clean Jane" (sodium dodecylsulfate (Tide)]. 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.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 3 1998

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

Re : K980349 QuikPac II One Step Barbiturate Test Requlatory Class: II Product Code: DIS January 26, 1998 Dated: January 28, 1998 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 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 requlatory 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 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 Gutman

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): To be Assigned

Device Name: QuikPac II One Step Barbiturate Test

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory Devices
510(k) Number JC9800344

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).