OnTrak TesTcup® 5 is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 simultaneously tests for the presence of multiple drugs or drug metabolites.

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

OnTrak TesTcup 5 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 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 (300 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 . 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 document describes the acceptance criteria and study results for the OnTrak TesTcup-5 device, specifically focusing on its performance for Phencyclidine (PCP) detection.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria (Implied)	Reported Device Performance (OnTrak TesTcup-5)
PCP Performance: Accuracy (Positive)	High sensitivity (detect all true positives) at 25 ng/mL cutoff.	90 PCP positive samples (confirmed by GC/MS at 25 ng/mL cutoff) were all positive by OnTrak TesTcup 5 (100% positive agreement).
PCP Performance: Accuracy (Negative)	High specificity (detect all true negatives) at 25 ng/mL cutoff.	307 urine samples (screened negative by automated immunoassay relative to 25 ng/mL cutoff for PCP) were all negative for PCP by OnTrak TesTcup 5 (100% negative agreement).
PCP Performance: Overall Agreement	High overall agreement with a predicate device/established method.	397 samples tested by both OnTrak TesTcup 5 and Abuscreen OnLine for PCP demonstrated 100% agreement. (This implies comparison to another immunoassay, not necessarily the gold standard, but serves as a comparative performance metric to the predicate which also showed 100% agreement with Abuscreen OnTrak). The predicate device (OnTrak TesTcup 5 with old PCP monoclonal antibody) itself showed 100% accuracy for both positive and negative samples, as detailed in the first two rows for the new device.
Precision	>95% confidence at 150% cutoff	>95% confidence at 150% cutoff (Same as predicate)

2. Sample size used for the test set and the data provenance

Test Set Sample Sizes:
- PCP Positive Samples: 90 urine samples (for evaluating positive accuracy).
- PCP Negative Samples: 307 urine samples (for evaluating negative accuracy).
- Overall Agreement/Comparison to Abuscreen OnLine: 397 samples.
Data Provenance: The urine samples for the accuracy testing were "obtained from a clinical laboratory". The document does not specify the country of origin. The study is retrospective, using existing urine samples that have already been screened and confirmed.

3. 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. However, the ground truth for positive PCP samples was established by GC/MS (Gas Chromatography/Mass Spectrometry) at the 25 ng/mL cutoff. This is a laboratory-based instrumental method, not typically relying on expert human interpretation for primary ground truth determination in this context. Negative samples were screened by "an automated immunoassay" and then confirmed as negative, implying GC/MS confirmation was likely also used for discordant results or for a subset of negatives.

4. Adjudication method for the test set

The document does not describe any human adjudication method (e.g., 2+1, 3+1). The ground truth was established instrumentally (GC/MS) for positive samples and by automated immunoassay screening for negative samples.

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 an in vitro diagnostic test for drug detection, and its output (color change indicating positive or negative) is interpreted directly, not through complex image analysis or reader interpretation that would necessitate an MRMC study. There is no AI component mentioned in the document.

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

Yes, a standalone performance evaluation was done. The device itself (OnTrak TesTcup-5) is the "algorithm" in this context, providing a direct visual result. The accuracy metrics (100% for positive and negative samples) directly reflect the device's standalone performance compared to the established ground truth.

7. The type of ground truth used

The primary ground truth used for PCP positive samples was GC/MS (Gas Chromatography/Mass Spectrometry). For negative samples, the ground truth was established by screening with an automated immunoassay relative to the 25 ng/mL cutoff for PCP. "Abuscreen OnLine for PCP" was also used for comparative purposes and showed 100% agreement. GC/MS is a highly specific and sensitive analytical method considered the gold standard for drug confirmation in urine.

8. The sample size for the training set

The document does not specify a separate training set or its sample size. This type of in vitro diagnostic device typically undergoes extensive R&D and validation during its development, but the premarket notification focuses on the final validation study results rather than detailing internal development and training data. The study described focuses on the performance testing of the finalized device.

9. How the ground truth for the training set was established

As no specific training set is mentioned or detailed, the method for establishing its ground truth is not provided in this document.

Summary

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(JAN 2 7 2000

K994030

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-5	EnzymeImmunoassay,Phencyclidine	91LCM	Unassigned

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

ﺗ

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510(k) Summary, Continued

The OnTrak TesTcup-5 is an in vitro diagnostic test intended for professional 4) Device Description use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 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 . 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. Table 1 shown on the next page outlines the technological characteristics 5. Technology Characteristics (methodologies) of the modified OnTrak TesTcup-5 in comparison to the predicate OnTrak TesTcup 5.

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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 . The significant performance characteristics Equivalence 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 device is substantially equivalent to the predicate device.

Table 1

Item	OnTrak TesTcup-5New PCP Monoclonal Antibody	OnTrak TesTcup 5Predicate
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.• Drug conjugates immobilized on amembrane• Mouse monoclonal anti-BSAantibody immobilized on membrane	• Blue dyed microparticlescoated with rabbit polyclonalantiphencyclidine.• Drug conjugates immobilizedon a 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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Table 1 (Continued)

Item	OnTrak TesTcup-5New PCP MonoclonalAntibody	OnTrak TesTcup 5Predicate
PCPPerformance:Accuracy	OnTrak TesTcup 5 was evaluatedusing specimens screened by anautomated immunoassay andconfirmed positive by GC/MS atthe 25 ng/mL cutoff. All ninety(90) of the PCP positive samples(100%) were positive by OnTrakTesTcup 5.	OnTrak TesTcup 5 was evaluatedusing specimens screened by anautomated immunoassay andconfirmed positive by GC/MS atthe 25 ng/mL cutoff. All ninety(90) of the PCP positive samples(100%) were positive by OnTrakTesTcup 5.
	Three hundred seven (307) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 25 ng/mL cutoff forPCP were evaluated usingOnTrak TesTcup 5. All threehundred seven (307) werenegative for PCP (100%)	Three hundred seven (307) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 25 ng/mL cutoff forPCP were evaluated usingOnTrak TesTcup 5. 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 tested byboth OnTrak TesTcup 5 andAbuscreen OnLine for PCPdemonstrated 100%	All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnTrakfor PCP. Three hundred ninetyseven (397) samples tested byboth OnTrak TesTcup 5 andAbuscreen OnTrak for PCPdemonstrated 100% agreement.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Jan 2 7 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K994030 Re: Trade Name: OnTrak TesTcup-5 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 (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.

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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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup-5

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ocan Coazer

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994030

Prescription Use ﻟﻌﺴﺮ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

N/A