TCPI's One Step™ Urine Drug of Abuse Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates 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. TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites.

Device Description

TCPI's One Step™ Urine Drug of Abuse: 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 cutoff 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

Since this refers to a 510(k) submission for a laboratory test, the term "device" refers to the "One Step™ Urine Drug of Abuse Barbiturate Test." The "algorithm" is the test itself, which is a qualitative competitive binding immunoassay.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
In-House Testing
Relative Sensitivity (Positives)	High agreement with predicate	1.00 (100%)
Relative Specificity (Negatives)	High agreement with predicate	1.00 (100%)
Accuracy	High agreement with predicate	100%
Clinical Trial
Relative Sensitivity (Positives)	High agreement with GC/MS	97.96%
Relative Specificity (Negatives)	High agreement with GC/MS	100%
Accuracy	High agreement with GC/MS	98.99%

Note: The document doesn't explicitly state quantitative acceptance criteria prior to reporting results (e.g., "sensitivity must be >95%"). Instead, it presents the results as evidence of performance compared to established methods.

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

Test Set Sample Size:
- In-house testing: Not explicitly stated, but performed against Syva EMIT® II on an unspecified number of "samples documented to be positive by GC/MS."
- Clinical Trial: 296 samples.
Data Provenance: The document does not specify the country of origin. It indicates the data is retrospective as the samples were collected and then tested. The samples were "documented to be positive by GC/MS" (for in-house testing) or "All positive samples by either screening method were confirmed by GC/MS" (for the clinical trial), implying these were pre-existing samples.

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

There were no human "experts" establishing the ground truth in the traditional sense of medical image interpretation (e.g., radiologists). The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemistry technique considered the "gold standard" for drug confirmation. Therefore, the "qualification" of the expert is the GC/MS instrument and the analytical chemists operating it.

4. Adjudication Method for the Test Set

Not applicable in the human expert sense. For the clinical trial, any sample that was positive by either the One Step™ test or the predicate screening method (Syva EMIT® II) was confirmed by GC/MS. This acts as a definitive adjudicator for discrepancies or initial positives.

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 study was not done. This device is an in-vitro diagnostic test (a chemical assay), not an AI-powered diagnostic imaging tool that would typically involve human readers (like radiologists) interpreting results with or without AI assistance. The "reader" is the test itself, which provides a qualitative "positive" or "negative" result.

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

Yes, the performance reported for the "One Step™ Urine Drug of Abuse: Barbiturate Test" is its standalone performance. This device is a rapid, qualitative immunoassay that produces a visual result (color band absence/presence), effectively acting as an "algorithm" (chemical reaction yielding a result) without direct human interpretation beyond reading the positive/negative indicator. Humans don't "interpret" the raw chemical reaction; they observe the final, designed output.

7. The Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) confirmation. For the in-house testing, it was also compared against the Syva EMIT® II assay as a predicate, with GC/MS as a confirmatory "ground truth" for those initial positives.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This is a chemical immunoassay, not an AI/ML model that undergoes a training phase with a distinct dataset. The development and optimization of the assay would involve various experiments, but these are not typically referred to as a "training set" in this context.

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

As explained above, there isn't a "training set" in the AI/ML sense for this device. The development of the assay would have been based on established chemical principles for antibody-antigen binding and optimized for specificity and sensitivity to barbiturates, calibrated against known concentrations of barbiturates, likely using GC/MS or other established analytical methods to confirm concentrations of these known samples.

Summary

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OCT - 2 1997

510k Submission for One Step™ Urine Drug of Abuse Barbiturate Technical Chemicals and Products, Inc. (TCPI).

Revision A 7/10//97 Printed on 8/13/97

Page 69 of 69

Summary of Safety and Effectiveness

The sponsor, Technical Chemicals and Products, Inc. (TCPI) (3341 S.W. 15th Street, Pompano Beach, Fl., 33069), 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 One Step™ Urine Drug of Abuse: 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 TCPI's One Step™ Urine Drug of Abuse: Barbiturate Test yielded a relative sensitivity or agreement within positives and relative specificity or agreement within negatives of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 296 samples was run and the combined data yielded a relative sensitivity or agreement within positives of 97.96%, a relative specificity or agreement within negatives of 100% with an accuracy of 98.99%.

All positive samples by either screening method were confirmed by GC/MS. Four of the 3 samples were negative for Barbiturate, but positive for other drugs by GC/MS. The three samples were positive for either Bromocriptine or Zoloft.

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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 2 1997

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

K973047 Re : OneStep™ Urine Drug of Abuse: Barbiturate Test Requlatory Class: II Product Code: DIS Dated: August 13, 1997 Received: August 15, 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 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 Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 regulations.

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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 requlation (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): Not yet Assigned

Device Name: One Step™ Urine Drug of Abuse Barbiturate Test

Indications For Use:

INTENDED USE

TCPI's One Step™ Urine Drug of Abuse Barbiturate Test is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturates 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. TCPI's One Step™ Urine Drug of Abuse: 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

Concurrence of CDRH. Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical I 510(k) Numbe Prescription Use: Over The Counter Use: Or (Per 21 CFR 801.109 (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).