On Trak TesTcard 9 product, is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. On Trak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites at or above the stated concentrations.
Cutoff Concentrations:
Amphetamines 1000 ng/mL
Barbiturates 200 ng/mL
Benzodiazepines 100 ng/mL
Cocaine metabolite 300 ng/mL
Methamphetamine 500 ng/mL
Morphine 300 ng/mL
Phencyclidine (PCP) 25 ng/mL
Tricyclic Antidepressants (TCA) 1000 ng/mL
Tetrahydrocannabinols (THC) 50 ng/mL

Device Description

On Trak TesTcard 9 product provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in the provided document beyond the qualitative nature of the test. However, the device is intended for the "qualitative detection of drug or drug metabolites in urine" at or above specific cutoff concentrations. Therefore, the device would be expected to accurately identify the presence or absence of these substances at the given thresholds. The reported performance is not detailed in terms of sensitivity, specificity, or accuracy compared to the gold standard, but the statement about "preliminary analytical test result" and the recommendation for "Gas chromatography/ mass spectrometry (GC/MS) as the preferred confirmation method" implies that the device serves as a screening tool.

Analyte	Cutoff Concentration (ng/mL)	Device Performance (Implied)
Amphetamines	1000	Qualitative detection at/above cutoff
Barbiturates	200	Qualitative detection at/above cutoff
Benzodiazepines	100	Qualitative detection at/above cutoff
Cocaine metabolite	300	Qualitative detection at/above cutoff
Methamphetamine	500	Qualitative detection at/above cutoff
Morphine	300	Qualitative detection at/above cutoff
Phencyclidine (PCP)	25	Qualitative detection at/above cutoff
Tricyclic Antidepressants	1000	Qualitative detection at/above cutoff
Tetrahydrocannabinols	50	Qualitative detection at/above cutoff

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

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method

The document does not provide information on the adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human reader improvement with AI assistance. This type of study is generally not applicable to a qualitative diagnostic test like the On Trak TesTcard 9, which is designed for standalone analysis rather than human-AI collaboration.

6. Standalone Performance Study

The study described is inherently a standalone performance study. The device, On Trak TesTcard 9, is an "in vitro diagnostic test" intended for "qualitative detection," meaning it produces a result without human interpretation of complex outputs.

7. Type of Ground Truth Used

While not explicitly stated, the implication that "Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmation method" suggests that GC/MS is intended to be the gold standard or ground truth for confirming the results of the On Trak TesTcard 9.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established. Given the nature of a rapid diagnostic test, the "training set" might refer to well-characterized samples with known concentrations of drug metabolites, likely confirmed by a highly accurate method like GC/MS.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.

APR 1 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorna Gamboa Regulatory Affairs and Quality Affairs Manager Varian, Inc. 25200 Commercentre Drive Lake Forest, California 92630

Re: K050321

Trade/Device Name: Varian, Inc. On Trak TesTcard 9 Regulation Number: 21 CFR § 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: II Product Code: DKZ, DIS, JXM, DIO, LAF, DJJ, LCM, LFG, LDJ Dated: February 3, 2005 Received: February 9, 2005

Dear Ms. Gamboa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 –

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sean M. Cooper, MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K050321 On Trak TesTcard 9 Device Name: K050321 Indications For Use:

Cutoff Concentrations:

Amphetamines	1000 ng/mL	Morphine	300 ng/mL
Barbiturates	200 ng/mL	Phencyclidine (PCP)	25 ng/mL
Benzodiazepines	100 ng/mL	Tricyclic Antidepressants (TCA)	1000 ng/mL
Cocaine metabolite	300 ng/mL	Tetrahydrocannabinols (THC)	50 ng/mL
Methamphetamine	500 ng/mL

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign Off

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) kos0321

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Carol Benson
Division Sign-Off

Offic = Device I voluation and Safety

K05 6321

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Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).