OnTrak TesTcup®5 M2K is an in vitro 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 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. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse result, particularly when preliminary positive results are used.

Device Description

The OnTrak TesTcup-5 M2K is an in vitro 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

Here's an analysis of the acceptance criteria and study details for the OnTrak TesTcup-5 M2K device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (OnTrak TesTcup-5 M2K New PCP Monoclonal Antibody)
PCP Cutoff	25 ng/mL
Precision	>95% confidence at 150% cutoff
PCP Performance: Accuracy (Positive)	100% (90 out of 90 PCP positive samples detected)
PCP Performance: Accuracy (Negative)	100% (307 out of 307 PCP negative samples detected)
Overall Agreement with Abuscreen OnLine for PCP	100% (397 samples tested with both devices)

Study Details

Sample sizes used for the test set and the data provenance:
- PCP Positive Samples: 90 samples
- PCP Negative Samples: 307 samples
- Total Samples for Agreement with Abuscreen OnLine: 397 samples
- Data Provenance: The negative urine samples were obtained from a clinical laboratory. Positive samples were screened by an automated immunoassay and confirmed positive by GC/MS. The text does not explicitly state the country of origin, but given the submission is to the FDA, it is likely US-based or intended for the US market. The studies appear to be retrospective as they involve predefined sets of samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth.
- For positive samples, the ground truth was established by GC/MS confirmation.
- For negative samples, the ground truth was established by screening negative by an automated immunoassay.
Adjudication method for the test set:
- The document does not mention an adjudication method. The ground truth was established by GC/MS or automated immunoassay screening.
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 test that provides a qualitative result (color change), not an AI-powered diagnostic image analysis tool requiring human reader interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The device, OnTrak TesTcup-5 M2K, directly provides the result (presence or absence of blue band) based on its chemical reactions, without human interpretation for the result itself. The results obtained from the device were then compared to the ground truth (GC/MS or automated immunoassay).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For PCP Positive samples: Confirmed positive by GC/MS.
- For PCP Negative samples: Screened negative by an automated immunoassay.
- This is a form of reference method (GC/MS) and established screening method (automated immunoassay).
The sample size for the training set:
- The document does not explicitly mention a "training set" or its sample size. For an in vitro diagnostic device like this, the development process typically involves internal validation and optimization, rather than a distinct "training set" in the machine learning sense. The performance data presented are for the evaluation/test set.
How the ground truth for the training set was established:
- Since no explicit training set is mentioned in the context of machine learning, this question is not directly applicable. For the device's development and internal validation, it's reasonable to infer that various concentrations of drugs and control samples would have been used, with their concentrations verified by established analytical methods such as GC/MS.

Summary

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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 46250Contact Person: Jennifer TribbettDate Prepared: November 24, 1999
2) Device name

Product Name	ClassificationName	Product Code	CFRClassification
OnTrak TesTcup-5M2K	EnzymeImmunoassay,Phencyclidine	91LCM	Unassigned

Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTcup-5 M2K (K990337).

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510(k) Summary, Continued

4) Device Description	The OnTrak TesTcup-5 M2K is an in vitro 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.
5. Technology Characteristics	Table 1 shown on the next page outlines the technological characteristics (methodologies) of the modified OnTrak TesTcup-5 M2K in comparison to the predicate device.

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510(k) Summary, Continued

Table 1 also provides the results of evaluation studies performed using the 6. Substantial modified OnTrak TesTcup-5 M2K . The significant performance Equivalence characteristics relied upon for a determination of substantial equivalence is summarized in this chart. This information concludes that the performance of the modified OnTrak TesTcup-5 M2K device is substantially equivalent to the predicate device.

Table 1

Item	OnTrak TesTcup-5 M2KNew PCP Monoclonal Antibody	OnTrak TesTcup-5 M2KPredicate
Methodology	Competitive microparticle captureinhibition	Same
Measurement	Qualitative	Same
Sample Type	Urine	Same
Endpoint read	Color	Same
PCP Cutoff	25 ng/mL	Same
Reagent(activeingredients)	•Blue dyed microparticles coatedwith mouse monoclonalantiphencyclidine.	•Blue dyed microparticlescoated with rabbit polyclonalantiphencyclidine.
	•Drug conjugates immobilized on amembrane	•Drug conjugates immobilizedon a membrane
	•Mouse monoclonal anti-BSAantibody immobilized on membrane	•Mouse monoclonal anti-BSAantibody immobilized on amembrane
Controls	OnTrak TesTcup Positive andNegative Controls	Same
Performance:Precision	>95% confidence at 150% cutoff	Same

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Item	OnTrak TesTcup-5 M2KNew PCP Monoclonal Antibody	OnTrak TesTcup-5 M2KPredicate
PCPPerformance:Accuracy	OnTrak TesTcup-5 M2K wasevaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at the 25ng/mL cutoff. All ninety (90) ofthe PCP positive samples (100%)were positive by OnTrakTesTcup-5 M2K.Three hundred seven (307) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 25 ng/mL cutoff forPCP were evaluated using OnTrakTesTcup-5 M2K. All threehundred seven (307) werenegative for PCP (100%)All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnLinefor PCP. Three hundred ninetyseven (397) samples by bothOnTrak TesTcup-5 M2K andAbuscreen OnLine for PCPdemonstrated 100% agreement	OnTrak TesTcup-5 M2K wasevaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at the 25ng/mL cutoff. All ninety (90) ofthe PCP positive samples(100%) were positive byOnTrak TesTcup-5 M2K.Three hundred seven (307) urinesamples, obtained from aclinical laboratory and screenednegative by an automatedimmunoassay relative to a 25ng/mL cutoff for PCP wereevaluated using OnTrakTesTcup-5 M2K. All threehundred seven (307) werenegative for PCP (100%)All positive and negativesamples were also assayed by,and compared to, AbuscreenOnTrak for PCP. Three hundredninety seven (397) samplestested by both OnTrak TesTcup-5 M2K and Abuscreen OnTrakfor PCP demonstrated 100%

Table 1 (Continued)

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Image /page/4/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 an eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 7 2000

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

Re: K994017 Trade Name: OnTrak TesTcup-5 M2K Regulatory Class: II Product Code: LCM Dated: November 24 1999 Received: November 26, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

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Page 2

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" (21CFR 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

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).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Cooger
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994017

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A