The ONTRAK TESTCUP -er is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. ONTRAK TESTCUP-er simultaneously tests for the presence of multiple drugs or drug metabolites. The ONTRAK TESTCUP - er profile consists of amphetamines (1000 ng/mL cutoff), cocaine metabolite (300 ng/mL cutoff), barbiturates (200 ng/mL cutoff), benzodiazepines (200 ng/mL), and morphine (300 ng/mL cutoff).

Measurements obtained by this device are used in the diagnosis and treatment of amphetamine, cocaine, barbiturate, benzodiazepine, and morphine use or overdose.

Device Description

The ONTRAK TESTCUP-er is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. ONTRAK TESTCUP-er simultaneously tests for the presence of multiple drugs or drug metabolites. The ONTRAK TESTCUP-er profile consists of amphetamines (1000 ng/mL cutoff), cocaine metabolite (300 ng/mL cutoff), barbiturates (200 ng/mL cutoff), benzodiazepines (200 ng/mL), and morphine (300 ng/mL cutoff).

The ONTRAK TESTCUP-er is a modified version of the currently marketed ONTRAK TESTCUP. The ONTRAK TESTCUP-er test profile consists of amphetamines, cocaine metabolite, barbiturates, benzodiazepines, and morphine whereas the test profile for the ONTRAK TESTCUP consists of amphetamines, cannabinoids, cocaine metabolite, morphine and phencyclidine. Essentially, cannabinoids and phencyclidine have been replaced with barbiturate and benzodiazepine test strips to create what we now refer to as the ONTRAK TESTCUP-er.

AI/ML Overview

ONTRAK TESTCUP®-er Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

This document primarily focuses on the Barbiturates Assay and Benzodiazepines Assay components of the ONTRAK TESTCUP®-er.

Performance Characteristic	Acceptance Criteria (Predicate Device)¹	ONTRAK TESTCUP-er (Barbiturates)	ONTRAK TESTCUP-er (Benzodiazepines)
Precision	> 99% confidence at 50% and at 200% of cutoff	>95% confidence at 150% of cutoff	>95% confidence at 150% of cutoff
Accuracy	100% vs. GC/MS (N=48 positives)	100% vs. GC/MS (N=50 positives)	100% vs. GC/MS (N=50 positives)

¹ Note: The document presents the performance characteristics of the predicate devices as a point of comparison, implying these are the established benchmarks for substantial equivalence. Actual specific acceptance criteria for the new device as distinct from predicate are not explicitly stated, but are demonstrated through the "significant performance characteristics relied upon" for substantial equivalence.

2. Sample Size and Data Provenance for Test Set

Barbiturates Assay:
- Sample Size: N = 50 positives for accuracy testing.
- Data Provenance: Not specified, but generally in vitro diagnostic studies using patient samples are usually prospective laboratory studies. The document does not indicate a specific country of origin or whether it was retrospective.
Benzodiazepines Assay:
- Sample Size: N = 50 positives for accuracy testing.
- Data Provenance: Not specified, same considerations as for Barbiturates Assay.

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the use of experts to establish ground truth for the test sets.
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method rather than expert interpretation.

4. Adjudication Method

No adjudication method is mentioned, as the ground truth was established using an objective analytical method (GC/MS).

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

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic device for qualitative detection of substances in urine, not an imaging or interpretive device that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The reported precision and accuracy indicate the inherent performance of the device itself against objective analytical standards.

7. Type of Ground Truth Used

The type of ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS), which is an accepted gold standard analytical method for drug confirmation in urine.

8. Sample Size for Training Set

The document does not specify a separate training set or its sample size. For in vitro diagnostic devices like this, the development and verification process often involves iterative testing and refinement, but a distinct "training set" in the machine learning sense is not explicitly detailed. The reported performance is likely from a validation or test set after development.

9. How Ground Truth for Training Set Was Established

As no specific training set is identified, the method for establishing its ground truth is not described. However, it is reasonable to infer that any samples used in the development or initial validation phases would also have utilized methods like GC/MS to establish their true content.

Summary

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NOV 1 8 1998

Image /page/0/Picture/1 description: The image shows the number K983388 at the top. Below the number is the Roche logo, which is a hexagon with the word Roche inside. The image is in black and white.

510(k) Summary

ONTRAK TESTCUP®-er

In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.

The assigned 510(k) number is: K983388

Identification of 510(k) Sponsor: I.

Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

510(k) Submission dated September 24, 1998

Rita Smith Contact: Senior Regulatory Affairs Associate Phone: (908) 253-7545 Fax:

Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

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II. Device Name:

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

Table 1

Product Name	Classification Name	CFR Number	Regulatory Class
ONTRAK TESTCUP-erBarbiturates	Enzyme Immunoassay,Barbiturates	862.3150	Class II
ONTRAK TESTCUP-erBenzodiazepines	Enzyme Immunoassay,Benzodiazepines	862.3170	Class II

Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

Product Name	Predicate Product Name	DatePredicateCleared	Predicate510(k)Number
ONTRAK TESTCUP-erBarbiturates	Abuscreen ONTRAK forBarbiturates	7/28/88	K881816
ONTRAK TESTCUP-erBenzodiazepines	Abuscreen ONTRAK forBenzodiazepines	4/5/91	K910590

Table 2

IV. Description of the Device/Statement of Intended Use:

The ONTRAK TESTCUP-er is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. ONTRAK TESTCUP-er simultaneously tests for the presence of multiple drugs or drug metabolites. The ONTRAK TESTCUP-er profile consists of amphetamines (1000 ng/mL cutoff), cocaine metabolite (300 ng/mL cutoff), barbiturates (200 ng/mL cutoff), benzodiazepines (200 ng/mL), and morphine (300 ng/mL cutoff).

Measurements obtained by this device are used in the diagnosis and treatment of amphetamine, cocaine, barbiturate, benzodiazepine, and morphine use or overdose.

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The ONTRAK TESTCUP was originally cleared on 12/3/94 (K944231) with a three test profile consisting of cannabinoids, cocaine, and morphine. The addition of amphetamines and phencyclidine were cleared under subsequent 510(k) filings on 10/7/96 (K962411) and 12/13/96 (K964355) respectively.

This submission, therefore, contains information specific to the new barbiturate and benzodiazepine test strips contained within the ONTRAK TESTCUP-er. The test strips for amphetamines, cocaine metabolite and morphine have not been changed from the previously cleared product. Information and data for these test strips are contained in (K944231) and (K962411).

V. Summary of the technological characteristics of the new device in comparison to those of the predicate.

Tables 3 and 4 outline the technological characteristics (methodologies) of the ONTRAK TESTCUP -er in comparison to those of legally marketed predicate products.

VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:

Tables 3 and 4 demonstrates the results of clinical and nonclinical studies performed using the ONTRAK TESTCUP-er. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to other legally marketed devices of a similar kind.

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ONTRAK TESTCUP Barbiturates Assay

Table 3

	ONTRAK TESTCUPBarbiturates Assay	Abuscreen ONTRAK forBarbiturates
Methodology	Competitive microparticlecapture inhibition	Competitive latexagglutination inhibition
Measurement	Qualitative	Qualitative
Sample type	urine	urine
Endpoint read	color	agglutination pattern
Cutoff(s)	200 ng/mL	200 ng/mL
Reagent(active ingredients)	1. Blue dyed microparticles coated with mouse monoclonal anti-barbiturates2. Drug conjugates immobilized on a membrane3. Mouse monoclonal anti-BSA immobilized on a membrane	1. Rabbit anti-barbiturate antibody in a buffered solution2. Reaction buffer3. Latex-barbiturate conjugate in a buffered solution
Performance Characteristics:
Precision	>95% confidence at 150% of cutoff	> 99% confidence at 50% and at 200% of cutoff
Accuracy	N = 50 positives100 % vs. GC/MS	N = 48 positives100 % vs. GC/MS

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ONTRAK TESTCUP Benzodiazepines Assay

Table 4

	ONTRAK TESTCUPBenzodiazepines Assay	Abuscreen ONTRAK forBenzodiazepines
Methodology	Competitive microparticlecapture inhibition	Competitive latexagglutination inhibition
Measurement	Qualitative	Qualitative
Sample type	urine	urine
Endpoint read	color	agglutination pattern
Cutoff(s)	200 ng/mL	100 ng/mL
Reagent(active ingredients)	1. Blue dyed microparticlescoated with sheeppolyclonal anti-benzodiazepines2. Drug conjugatesimmobilized on amembrane3. Mouse monoclonal anti-BSA immobilized on amembrane	1. Sheep anti-benzodiazepine antibodyin a buffered solution2. Reaction buffer3. Latex-benzodiazepineconjugate in a bufferedsolution
Performance Characteristics:
Precision	>95% confidence at 150% ofcutoff	> 99% confidence at 50% andat 200% of cutoff
Accuracy	N = 50 positives100 % vs. GC/MS	N = 67 positives98.5 % vs. GC/MS

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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features the department's seal, which includes an abstract image of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the seal.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 8 1998

Re:

Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic Systems, Inc. 1080 U.S. Highway 202 Somerville, NJ 08876-3771

K983388 Trade Name: OnTrak TesTcup-er Regulatory Class: II Product Code: DIO, DKZ, DKN, DJG, JXM Dated: September 24, 1998 Received: September 25, 1998

Dear Ms. Smith:

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

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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Gutman

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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Page 1 of 1

510(k) Number (if known) K 98 3388

Device Name: ONTRAK TESTCUP® - er

Indications for Use:

Measurements obtained by this device are used in the diagnosis and treatment of amphetamine, cocaine, barbiturate, benzodiazepine, and morphine use or overdose.

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K983388

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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

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).