The TCPI One Step™ Urine Drug of Abuse Amphetamine Test is a rapid, qualitative, competitive binding immunoassay for the determination of Amphetamine in urine. 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. The TCPI One Step™ Urine Drug of Abuse Amphetamine assay is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.

Device Description

TCPI's One Step™ Urine Drug of Abuse Amphetamine 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 500 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 the information about the acceptance criteria and study for the "One Step™ Urine Drug of Abuse Amphetamine Test":

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms (e.g., "accuracy must be >95%"). However, based on the provided text, the implicit acceptance criteria is a high level of accuracy when compared to a gold standard (GC/MS) and other screening tests. The device performance demonstrates that these implicit criteria were met.

Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Accuracy (Laboratory Study)	High accuracy vs. GC/MS	99.62% (on 260 samples)
Accuracy (Clinical Trials)	High accuracy vs. other methods	96.00% (on 300 patient samples)
Accuracy (Combined Data)	High accuracy	97.68% (on 560 total comparisons)
Accuracy (Excluding Ephedrine)	High accuracy without interference	99.82% (after dropping 12 ephedrine positive samples)
Comparison to Other Screening Tests	No significant difference	"clearly demonstrated no difference"

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

Laboratory Study: 260 samples
Clinical Trials: 300 patient samples
Combined Total: 560 comparisons

The text does not specify the country of origin for the data or whether it was retrospective or prospective. It refers to "laboratory studies" and "clinical trials," which typically involve prospective collection, but this is not explicitly stated.

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

The text does not mention the use of experts to establish ground truth.

4. Adjudication Method for the Test Set

The text does not mention any adjudication method for the test set.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a rapid, qualitative immunoassay for screening, not an image-based or interpretation-based device suitable for an MRMC study with human readers assisted by AI.

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

Yes, a standalone performance study was done. The device itself (the "One Step™ Urine Drug of Abuse Amphetamine Test") is the standalone "algorithm" in this context, providing a qualitative result without human interpretation of complex data. Its performance was tested directly against GC/MS and in clinical trials.

7. The Type of Ground Truth Used

The primary ground truth used was Gas Chromatography/Mass Spectrophotometry (GC/MS), widely considered the gold standard for drug confirmation testing. For the clinical trials, the comparison was implicitly against "other screening tests," but the overall and most robust ground truth mentioned is GC/MS.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its size. In the context of a qualitative immunoassay, the development and optimization of the test (which could be analogous to "training") would typically involve numerous iterations and tests with various known positive and negative samples, but these are not explicitly detailed as a distinct "training set" in the submission's summary of safety and effectiveness. The reported sample sizes (260 lab, 300 clinical) are for the performance evaluation, which serves as the "test set."

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

Since a distinct training set with established ground truth is not explicitly mentioned, this information cannot be provided from the given text. However, for the general development of such a test, the ground truth for samples used in the chemical design and optimization would also be established by reference methods like GC/MS.

Summary

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K 981197

510k Submission for

JUN 16 1998 One Step™ Urine Drug of Abuse Amphetamine Test Technical Chemicals & Products, Inc.

Page 59 of 59

Revision A -3/15/98 Printed (3/31/98)

Statement of Safety and Effectiveness

The sponsor, Technical Chemicals and Products, Inc. (3340 S.W. 15th Street, Pompano Beach, Florida, 33069), has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Amphetamine and its metabolites in a screening format. This summary was originally written in May of 1995 and has been updated as of March, 1998.

The trade name of the device is One Step™ Urine Drug of Abuse Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a Class II device per 21 CFR ¶ 862.3100. This device is intended for professional medical/forensic screening of urine for Amphetamine.

The sponsor tested the product in laboratory studies against GC/MS. The accuracy of this 260 sample population was 99.62%. Subsequent clinical trials on 300 patient samples vielded a calculated accuracy of 96.00%. When the results of all testing is combined the total number of comparisons was 560 and the calculated accuracy was found to be 97.68%. If the 12 ephedrine positive samples are dropped the accuracy of the TCPI test is 99.82%. The comparison of results clearly demonstrated no difference between the TCPI One Step™ Urine Drug of Abuse Amphetamine Test and other screening tests as noted in the presentation of results. Like all of the screening methods tested TCPI's will report false positives when ephedrine and phenyl propanolamine are present.

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

发行办
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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 6 1898

Dr. Jeffrey Bolts . Director of Quality Assurance Technical Chemicals & Products, Inc. P.O. Box 8726 Ft. Lauderdale, Florida 33310

Re: K981197 One Step™ Urine Drug of Abuse Amphetamine Test Requlatory Class: II Product Code: DKZ Dated: March 31, 1998 Received: April 2, 1998

Dear Dr.Bolts:

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. ਉ 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 additi n, 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 requlations.

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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): As Yet to be Assigned

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

Indications For Use:

INTENDED USE

The TCPI One Step™ Urine Drug of Abuse Amphetamine Test is a rapid, qualitative, competitive binding immunoassay for the determination of Amphetamine in urine. 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. The TCPI One Step™ Urine Drug of Abuse Amphetamine assay is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use:
(Per 21 CFR 801.109 or

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

1244887
세상남도출장걸

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).