OnTrak TesTcup® 5 M2K is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup-5 M2K cutoff levels are based on the Federal Mandatory Guidelines.

The OnTrak TesTcup 5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).

OnTrak TesTcup 5 M2K provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Device Description

The OnTrak TesTcup-5 M2K is an in vitro diagnostic test intended for professional use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). The TesTcup assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. Urine is collected directly in the OnTrak TesTcup-5 M2K. After closing the cap and moving it to the "TEST" position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area for all assays. The "TEST VALID" blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed microparticles.

AI/ML Overview

The provided text describes the OnTrak TesTcup-5 M2K device, an in vitro diagnostic test for the qualitative detection of amphetamines, cocaine metabolite, THC, morphine, and PCP in urine. The key focus here is on the Morphine 2000 component of the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for OnTrak TesTcup-5 M2K (Morphine 2000)

Item	Acceptance Criteria (Implied / Predicate)	Reported Device Performance (OnTrak TesTcup-5 M2K for Morphine 2000)
Methodology	Competitive microparticle capture inhibition	Same
Measurement	Qualitative	Same
Sample Type	Urine	Same
Endpoint Read	Color	Same
Morphine Cutoff	300 ng/mL (Predicate)	2000 ng/mL (New Device)
Precision	>95% confidence at 150% cutoff (Predicate)	>95% confidence at 150% cutoff
Accuracy (Positive Samples)	100% detection of positive samples (Predicate: 90/90)	100% detection of positive samples (50/50)
Accuracy (Negative Samples)	>99% detection of negative samples (Predicate: 305/307)	100% detection of negative samples (100/100)
Agreement with Reference	99.7% agreement with Abuscreen OnTrak for Morphine (Predicate: 397 samples)	99.3% agreement with Abuscreen OnLine II for Opiates 2000 (150 samples)

Note: The acceptance criteria are largely implied by the performance of the predicate device. The new device demonstrates comparable performance despite a significantly higher morphine cutoff.

Study Details:

Sample Size used for the test set and the data provenance:
- Positive Samples: 50 urine samples.
- Negative Samples: 100 urine samples.
- Agreement Comparison Samples: 150 total samples (comprising the above positive and negative samples, as they were also compared to the reference assay).
- Data Provenance: The text states, "specimens screened by an automated immunoassay and confirmed positive by GC/MS" and "urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay." This indicates the data is retrospective and originates from a clinical laboratory, likely in the United States (given the FDA 510(k) submission).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The text does not explicitly state the number of experts or their qualifications for establishing ground truth.
- However, the ground truth for positive samples was established by GC/MS confirmation (Gas Chromatography/Mass Spectrometry), which is a definitive analytical method, generally considered the gold standard for drug confirmation. For negative samples, the ground truth was established by "screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff for morphine." While an immunoassay is a screening method, its negativity at the specified cutoff served as the ground truth in this context, coupled with confirmation for positive results.
Adjudication method for the test set:
- The text does not describe an adjudication method involving multiple human readers for interpreting test results. The device produces a "blue band" for negative and "remains white" for positive, suggesting a direct visual read without complex interpretation requiring adjudication. Performance was measured directly against the ground truth (GC/MS for positive, immunoassay for negative).
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 comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test, not an AI-powered image analysis system that assists human readers. Its output is a direct qualitative result (positive/negative), not an interpretation for human readers to act upon.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone test in the sense that the device itself generates the result without human interpretive input beyond reading the presence or absence of a blue band. There isn't an "algorithm-only" performance that would be separate from the "human-in-the-loop" as there's no complex human interpretation involved with this type of rapid diagnostic test for which an AI would assist.
The type of ground truth used:
- For positive samples, the ground truth was GC/MS confirmation.
- For negative samples, the ground truth was "screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff." This serves as a chemical/analytical truth based on established laboratory methods. It is not expert consensus, pathology, or outcomes data.
The sample size for the training set:
- The provided text does not mention or describe a training set for the device. This type of device (rapid immunoassay) typically does not involve a "training phase" in the same way machine learning or AI models do. Its reagents and test mechanisms are developed and validated, rather than "trained" on data.
How the ground truth for the training set was established:
- As no training set is described, this information is not applicable.

Summary

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9/23/99

K990337

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1) Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000
	Contact Person: Jennifer Tribbett
	Date Prepared: January 29, 1999

2) Device name

Product Name	Classification Name	Class	CFRClassification
OnTrak TesTcup®5M2K	Morphine test system	II	862.3640

We claim substantial equivalence to the currently marketed Roche 3) Predicate device Diagnostics OnTrak TesTcup 5 (K964355).

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510(k) Summary, Continued

The OnTrak TesTcup-5 M2K is an in vitro diagnostic test intended for 4) Device Description professional use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). The TesTcup assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. Urine is collected directly in the OnTrak TesTcup-5 M2K. After closing the cap and moving it to the "TEST" position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area for all assays. The "TEST VALID" blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed microparticles. 5. Technology Table 1 shown on the next page outlines the technological characteristics Characteristics (methodologies) of the OnTrak TesTcup-5 M2K in comparison to the predicate device. OnTrak TesTcup 5.

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510(k) Summary, Continued

Substantial Equivalence

Table 1 also provides the results of clinical and non-clinical studies performed using the OnTrak TesTcup-5 M2K. The significant performance characteristics relied upon for a determination of substantial equivalence is summarized in this chart. This information concludes that the performance of the OnTrak TesTcup 5 M2K device is substantially equivalent to the predicate device.

Item	OnTrak TesTcup-5 M2K forMorphine 2000	OnTrak TesTcup 5
Methodology	Competitive microparticle captureinhibition	Same
Measurement	Qualitative	Same
Sample Type	Urine	Same
Endpoint read	Color	Same
Morphine Cutoff	2000 ng/mL	300 ng/mL
Reagent (activeingredients)	•Blue dyed microparticles coatedwith mouse monoclonal anti-morphine antibody	Same
	•Drug conjugates immobilized on amembrane
	•Mouse monoclonal anti-BSAantibody immobilized onmembrane
Controls	OnTrak TesTcup Positive andNegative Controls	Same
Performance:Precision	>95% confidence at 150% cutoff	Same
Item	OnTrak TesTcup-5 M2K for Morphine 2000	OnTrak TesTcup 5
Morphine Performance: Accuracy	OnTrak TesTcup 5 M2K was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at 2000 ng/mL cutoff. All fifty (50) samples positive for morphine were positive by OnTrak TesTcup 5 M2K (100%).One hundred (100) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff for morphine were evaluated using OnTrak TesTcup 5 M2K. All one hundred were negative for morphine by OnTrak TesTcup 5 M2K (100%).All positive and negative samples were also assayed by, and compared to, Abuscreen OnLine II for Opiates 2000. One hundred fifty (150) samples tested by both OnTrak TesTcup 5 M2K and Abuscreen OnLine II for Opiates 2000 demonstrated 99.3% agreement.	OnTrak TesTcup 5 was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at the 300 ng/mL cutoff. All ninety (90) samples positive for morphine were positive by OnTrak TesTcup 5 (100%).Three hundred seven (307) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 300 ng/mL cutoff for morphine were evaluated using OnTrak TesTcup 5. Three hundred five were negative for morphine by OnTrak TesTcup 5 (>99%).All positive and negative samples were also assayed by, and compared to, Abuscreen OnTrak for Morphine. Three hundred ninety seven (397) samples tested by both OnTrak TesTcup 5 and Abuscreen OnTrak for Morphine demonstrated 99.7% agreement.

Table 1

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510(k) Summary, Continued

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Public Health Service

Image /page/4/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem consists of a stylized caduceus symbol, with three abstract human profiles facing right, representing health and human services.

FEB 2 3 1999

Ms. Jennifer L. Tribbett Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: K990337

Trade Name: OnTrak TesTcup® 5 M2K Regulatory Class: II Product Code: DKZ, DJG, DIO, LDJ, LCM Dated: January 29, 1999 Received: February 3, 1999

Dear Ms. Tribbett:

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 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). 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 regulatory action. In addition, FDA may publish further announcements 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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):

Device Name: Roche Diagnostics Corporation, OnTrak TesTcup-5 M2K for Morphine 2000

Indications for Use:

The OnTrak TesTcup 5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).

OnTrak TesTcup 5 M2K provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

ean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 32

Concurrence of CDRH, Office of Device Evaluation (on the of

1 Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

CONFIDENTIAL

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).