The ONTRAK TESTSTIK for Amphetamines is an in vitro diagnostic test intended for professional use for the qualitative detection of amphetamines in urine at or above a cutoff concentration of 1000 ng/mL.
The ONTRAK TESTSTIK for Cocaine is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite in urine at or above a cutoff concentration of 300 ng/mL.
The ONTRAK TESTSTIK for Morphine is an in vitro diagnostic test intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 300 ng/mL
The ONTRAK TESTSTIK for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of phencyclidine in urine at or above a cutoff concentration of 25 ng/mL.
The ONTRAK TESTSTIK for THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cannabinoids in urine at or above a cutoff concentration of 50 ng/mL.

Device Description

The 5 ONTRAK TESTSTIK Assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of drug or drug metabolite in urine. They are the ONTRAK TESTSTIK for Amphetamines (1000 ng/mL cutoff), the ONTRAK TESTSTIK for Cocaine (300 ng/mL cutoff), the ONTRAK TESTSTIK for THC (50 ng/mL cutoff), the ONTRAK TESTSTIK for Morphine (300 ng/mL cutoff) and the ONTRAK TESTSTIK for PCP (25 ng/mL cutoff).

The ONTRAK TESTSTIK Assays are based on the principle of microparticle capture inhibition. These tests rely on the competition between the specific drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane test chamber.

When an ONTRAK TESTSTIK is immersed in the urine sample, some of the sample is absorbed into the TESTSTIK sample pad. The absorbed sample travels through a reagent strip contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug conjugate. In the absence of drug in the urine, the antibody-coated microparticles bind to the drug conjugate and a blue band is formed at the result window ("negative" sign).

When drug is present in the specimen. it binds to the antibody-coated particles, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. Therefore, a positive sample causes the membrane to remain white ("positive" sign).

An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are embedded in the reagent membrane, bind to the antigen on the blue microparticles.

AI/ML Overview

This document describes the acceptance criteria and supporting study for the ONTRAK TESTSTIK Assays for various drugs of abuse (Amphetamines, Cocaine, Morphine, PCP, THC).

The study aims to demonstrate substantial equivalence to previously marketed predicate devices. The acceptance criteria essentially mirror the performance characteristics of the predicate devices and focus on precision and accuracy against a reference method.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a single set of predefined metrics that the new device must meet. Instead, it presents performance characteristics for both the new ONTRAK TESTSTIK assays and their predicate devices. The implicit acceptance criterion is that the ONTRAK TESTSTIK assays show comparable performance to the predicate devices. The tables below synthesize the reported performance, which effectively acts as the demonstrated acceptance of the device's capabilities.

ONTRAK TESTSTIK for Amphetamines

Performance Characteristic	Acceptance Criteria (from predicate)	Reported Device Performance (ONTRAK TESTSTIK)
Precision	> 99% confidence at 200% of cutoff	> 95% confidence at 150% cutoff
Accuracy (Positive Samples)	GC/MS: 45 positive, 1 negative	TESTSTIK: 50 positive, 0 negative

ONTRAK TESTSTIK for Cocaine

Performance Characteristic	Acceptance Criteria (from predicate)	Reported Device Performance (ONTRAK TESTSTIK)
Precision	> 99% confidence at 200% of cutoff	> 95% confidence at 150% cutoff
Accuracy (Positive Samples)	GC/MS: 49 positive, 0 negative	TESTSTIK: 50 positive, 0 negative

ONTRAK TESTSTIK for Morphine

Performance Characteristic	Acceptance Criteria (from predicate)	Reported Device Performance (ONTRAK TESTSTIK)
Precision	> 99% confidence at 200% of cutoff	> 95% confidence at 150% cutoff
Accuracy (Positive Samples)	GC/MS: 50 positive, 0 negative	TESTSTIK: 49 positive, 0 negative

ONTRAK TESTSTIK for PCP

Performance Characteristic	Acceptance Criteria (from predicate)	Reported Device Performance (ONTRAK TESTSTIK)
Precision	> 99% confidence at 200% of cutoff	> 95% confidence at 150% cutoff
Accuracy (Positive Samples)	GC/MS: 50 positive, 1 negative	TESTSTIK: 50 positive, 0 negative

ONTRAK TESTSTIK for THC

Performance Characteristic	Acceptance Criteria (from predicate)	Reported Device Performance (ONTRAK TESTSTIK)
Precision	> 99% confidence at 200% of cutoff	> 95% confidence at 150% cutoff
Accuracy (Positive Samples)	GC/MS: 45 positive, 0 negative	TESTSTIK: 45 positive, 0 negative

Note on "Acceptance Criteria" interpretation: The document refers to "significant performance characteristics relied upon for a determination of substantial equivalence" (Page 3). The tables then show the performance of both the new device and the predicate. Thus, the predicate's performance serves as the benchmark or de facto acceptance criteria for the new device to demonstrate substantial equivalence.

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

Sample Size:
- Amphetamines: 50 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 46 samples (45 positive, 1 negative).
- Cocaine: 50 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 49 samples (49 positive, 0 negative).
- Morphine: 49 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 50 samples (50 positive, 0 negative).
- PCP: 50 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 51 samples (50 positive, 1 negative).
- THC: 45 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 45 samples (45 positive, 0 negative).
- It is not explicitly stated how many negative samples were tested with the ONTRAK TESTSTIK for accuracy, only the positive sample count against the GC/MS reference.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The submission is from Roche Diagnostic Systems, Inc. in Somerville, New Jersey, USA, but this doesn't confirm the origin of the test samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The ground truth (reference method) is established using GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical laboratory technique, not human expert interpretation.

4. Adjudication method for the test set (e.g. 2+1, 3+1, none):

This information is not applicable/provided. The ground truth is established by an objective analytical method (GC/MS), not by human interpretation requiring adjudication.

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:

This is not an AI/CAD device. The ONTRAK TESTSTIK Assays are in vitro diagnostic tests for qualitative detection of drugs in urine. Therefore, an MRMC study and AI assistance are not relevant.

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

The device is a standalone chemical assay. Its performance is evaluated intrinsically through chemical reactions, not through an algorithm. The reported accuracy metrics relate to the device's ability to produce a correct result when compared to a reference standard. There isn't an "algorithm-only" performance as the device itself is the testing mechanism. The human interaction is limited to operating the device and visually interpreting the "color" endpoint (blue band for negative, no blue band for positive).

7. The type of ground truth used:

The ground truth for the accuracy studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is considered a highly reliable and definitive analytical method for confirming the presence and concentration of drugs and metabolites in urine samples.

8. The sample size for the training set:

There is no mention of a training set as this is an in vitro diagnostic chemical assay, not an AI/machine learning device. The performance data presented are from validation studies.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the word "Roche" in bold, white letters against a black, hexagon-shaped background. The hexagon is oriented horizontally, with the word "Roche" centered within it. The font is sans-serif and appears to be a simple, clean design.

Roche Diagnostic Systems

A Member of the Roche Group

Roche Diagnostic Systems, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Direct Dial Fax

K973075

510(k) Summary

ONTRAK TESTSTIK Assays

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

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 August 15, 1997

James W. Haynes Contact: Regulatory Affairs Associate Phone: (908) 253-7569 Fax: (908) 253-7547

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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.

Proprietary Name	Classification Name	Regulation Number
ONTRAK TESTSTIK for...
Amphetamines	Amphetamines test system	862.3100
Cocaine	Cocaine test system	862.3250
Morphine	Morphine test system	862.3640
PCP	Phencyclidine test system	NA
THC	Cannabinoid test system	862.3870

Table 1

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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.

Proprietary Name	Predicate Product Name	K number	Date of substantialequivalence
ONTRAK TESTSTIK for...
Amphetamines	Abuscreen ONTRAK for Amphetamines	K881817/A	7/29/88
Cocaine	Abuscreen ONTRAK for Cocaine	K881815	7/29/88
Morphine	Abuscreen ONTRAK for Morphine	K882496	9/2/88
PCP	Abuscreen ONTRAK for PCP	K895906	1/26/90
THC	Abuscreen ONTRAK for THC	K904856	12/13/90

Table 2

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

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

Tables 3-7 outline the technological characteristics (methodologies) of the ONTRAK TESTSTIK Assays 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 3-7 demonstrate the results of clinical and nonclinical studies performed using the ONTRAK TESTSTIK Assays. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this information concludes that the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind.

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Table 3 - ONTRAK TESTSTIK for Amphetamines
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	ONTRAK TESTSTIKfor Amphetamines	Abuscreen ONTRAK forAmphetamines
Methodology	Competitive microparticle captureinhibition	Competitive latex agglutinationinhibition
Measurement	Qualitative	Qualitative
Sample type	urine	urine
Endpoint read	color	agglutination pattern
Cutoff(s)	1000 ng/mL	1000 ng/mL
Reagent (activeingredients)	1. Blue dyed microparticles coatedwith mouse monoclonal anti-amphetamine analogue2. Drug conjugates immobilized on amembrane3. Mouse monoclonal anti-BSAantibody immobilized on amembrane	1. Sheep anti-amphetamineantibody in a bufferedsolution2. Reaction buffer3. Latex-amphetamineconjugate in a bufferedsolution
Controls	ONTRAK TESTCUP Positive & NegativeControls	Abuscreen ONTRAK forAmphetamines Negative Control
Performance Characteristics:
Precision	> 95% confidence at 150% cutoff	> 99% confidence at 200% ofcutoff
Accuracy:Positive Samples	TesTstik	GC/MS
+	50	45
-	0	1

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Table 4 - ONTRAK TESTSTIK for Cocaine

	ONTRAK TESTSTIKfor Cocaine		Abuscreen ONTRAK forCocaine
Methodology	Competitive microparticle captureinhibition		Competitive latex agglutinationinhibition
Measurement	Qualitative		Qualitative
Sample type	urine		urine
Endpoint read	color		agglutination pattern
Cutoff(s)	300 ng/mL		300 ng/mL
Reagent (activeingredients)	1. Blue dyed microparticles coatedwith mouse monoclonal anti-benzoylecgonine antibody2. Drug conjugates immobilized on amembrane3. Mouse monoclonal anti-BSAantibody immobilized on amembrane		1. Mouse monoclonal anti-benzoylecgonine antibody ina buffered solution2. Reaction buffer3. Latex- benzoylecgonineconjugate in a bufferedsolution
Controls	ONTRAK TESTCUP Positive & NegativeControls		Abuscreen ONTRAK for CocaineNegative Control
Performance Characteristics:
Precision	> 95% confidence at 150% cutoff		> 99% confidence at 200% ofcutoff
Accuracy:Positive Samples		TESTSTIKONTRAK	GC/MSGC/MS
	+	5050	490
	-	00	00

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	ONTRAK TESTSTIKfor Morphine		Abuscreen ONTRAK forMorphine
Methodology	Competitive microparticle captureinhibition		Competitive latex agglutinationinhibition
Measurement	Qualitative		Qualitative
Sample type	urine		urine
Endpoint read	color		agglutination pattern
Cutoff(s)	300 ng/mL		300 ng/mL
Reagent (activeingredients)	1. Blue dyed microparticles coatedwith mouse monoclonal anti-morphine antibody2. Drug conjugates immobilized on amembrane3. Mouse monoclonal anti-BSAantibody immobilized on amembrane		1. Mouse anti- morphineantibody in a bufferedsolution2. Reaction buffer3. Latex-morphine conjugate ina buffered solution
Controls	ONTRAK TESTCUP Positive & NegativeControls		Abuscreen ONTRAK forMorphine Negative Control
Performance Characteristics:
Precision	> 95% confidence at 150% cutoff		> 99% confidence at 200% ofcutoff
Accuracy:Positive Samples		TESTSTIK49	ONTRAK GC/MS50 GC/MS54

Table 5 - ONTRAK TESTSTIK for Morphine

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Table 6 - ONTRAK TESTSTIK for PCP

	ONTRAK TESTSTIKfor PCP		Abuscreen ONTRAK for PCP
Methodology	Competitive microparticle capture inhibition		Competitive latex agglutination inhibition
Measurement	Qualitative		Qualitative
Sample type	urine		urine
Endpoint read	color		agglutination pattern
Cutoff(s)	25 ng/mL		25 ng/mL
Reagent (active ingredients)	1. Blue dyed microparticles coated with rabbit polyclonal anti-phencyclidine antibody2. Drug conjugates immobilized on a membrane3. Mouse monoclonal anti-BSA antibody immobilized on a membrane		1. Rabbit anti- phencyclidine antibody in a buffered solution2. Reaction buffer3. Latex- phencyclidine conjugate in a buffered solution
Controls	ONTRAK TESTCUP Positive & Negative Controls		Abuscreen ONTRAK for PCP Negative Control
Performance Characteristics:
Precision	> 95% confidence at 150% cutoff		> 99% confidence at 200% of cutoff
Accuracy:Positive Samples		TESTSTIK	ONTRAK	GC/MS	GC/MS
	+	50	50	50	52
	-	0	0	0	1

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	ONTRAK TESTSTIKfor THC	Abuscreen ONTRAK for THC
Methodology	Competitive microparticle captureinhibition	Competitive latex agglutinationinhibition
Measurement	Qualitative	Qualitative
Sample type	urine	urine
Endpoint read	color	agglutination pattern
Cutoff(s)	50 ng/mL	50 ng/mL
Reagent (activeingredients)	1. Blue dyed microparticles coatedwith mouse monoclonal anti-cannabinoid antibody2. Drug conjugates immobilized on amembrane3. Mouse monoclonal anti-BSAantibody immobilized on amembrane	1. Mouse monoclonal anti-cannabinoid in a bufferedsolution2. Reaction buffer3. Latex-tetrahydrocannabinoidconjugate in a bufferedsolution
Controls	ONTRAK TESTCUP Positive & NegativeControls	Abuscreen ONTRAK for THCNegative Control
Performance Characteristics:
Precision	> 95% confidence at 150% cutoff	> 99% confidence at 200% ofcutoff
Accuracy:Positive Samples	TESTSTIK	ONTRAK	GC/MS	GC/MS
	+	45	45	45	50
	-	0	0	0	0

Table 7 - ONTRAK TESTSTIK for THC

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Image /page/9/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James W. Haynes Regulatory Affairs Associate Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

OCT - 9 1997

Re: K973075 Trade Name: OnTrak TesTstik Assays Requlatory Class: II Product Code: DKZ Dated: Auqust 15, 1997 Received: August 18, 1997

Dear Mr. Haynes:

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 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 requlations 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 requirement, 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 Druq 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 qeneral 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 Butman

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) Jan 9730 73

ONTRAK TESTSTIK for Amphetamines Device Name: ONTRAK TESTSTIK for Cocaine ONTRAK TESTSTIK for Morphine ONTRAK TESTSTIK for PCP ONTRAK TESTSTIK for THC

Indications for Use:

1. The ONTRAK TESTSTIK for Amphetamines is an in vitro diagnostic test intended for professional use for the qualitative detection of amphetamines in urine at or above a cutoff concentration of 1000 ng/mL.
  Page 1 of 1

1. The ONTRAK TESTSTIK for Cocaine is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite in urine at or above a cutoff concentration of 300 ng/mL.
1. The ONTRAK TESTSTIK for Morphine is an in vitro diagnostic test intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 300 ng/mL
1. The ONTRAK TESTSTIK for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of phencyclidine in urine at or above a cutoff concentration of 25 ng/mL.
1. The ONTRAK TESTSTIK for THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cannabinoids in urine at or above a cutoff concentration of 50 ng/mL.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

Prescription Use(Per 21 CFR 801,109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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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).