The Roche Diagnostics Corporation OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC.

Device Description

The OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC. The OnTrak TesTcup M2K/OnTrak TesTstik Controls are prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservatives and stabilizers are added to maintain product integrity.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the OnTrak TesTcup M2K/OnTrak TesTstik Controls:

1. Acceptance Criteria and Reported Device Performance

The device under review is a quality control material, not a diagnostic device with performance metrics like sensitivity or specificity. Its "performance" is primarily defined by the concentration of drug or drug metabolites it contains. The acceptance criteria are implicitly that the control material contains the specified concentrations of the substances. The "study" described is a comparison of the new control material's formulation (specifically, the morphine level and the addition of oxazepam) to predicate devices.

Analyte	Acceptance Criteria (Target Concentration in Positive Control)	Reported Device Performance (Concentration in Modified OnTrak TesTcup M2K and TesTstik Controls - Positive)
Amphetamines	2500 ng/mL	2500 ng/mL
Cannabinoids	125 ng/mL	125 ng/mL
Cocaine	750 ng/mL	750 ng/mL
Morphine	5000 ng/mL	5000 ng/mL
Phencyclidine	62.5 ng/mL	62.5 ng/mL
Secobarbital	500 ng/mL	500 ng/mL
Oxazepam	500 ng/mL	500 ng/mL

Note: The negative controls are consistently reported as 0 ng/mL for all drugs, which is implicitly the acceptance criteria for negative controls to be drug-free.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size of a "test set" in the traditional sense for diagnostic performance. This is a quality control product, and the "testing" involves ensuring the prepared control materials contain the intended drug concentrations. The data provenance is implied to be from internal laboratory preparation and testing by Roche Diagnostics Corporation in Indianapolis, IN, USA. The study design is focused on demonstrating the composition of the control materials rather than their diagnostic performance against patient samples. It's a characterization of the control product itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for a quality control material is its precisely prepared composition (i.e., known-added concentrations of analytes), not an expert interpretation of a diagnostic output.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication because the "ground truth" is the known chemical composition of the control material.

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

Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and therefore, an MRMC study and AI assistance are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used is the known, quantitative addition of drug or drug metabolite to drug-free human urine during the manufacturing process of the control material. This is a highly controlled, synthetic "ground truth" established by the product's formulation.

8. The Sample Size for the Training Set

Not applicable. This is a quality control material, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved. The "ground truth" for the control material itself is established by its precise manufacturing formulation and verified through analytical chemistry methods.

Summary

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2/26/99

K990377

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.

Submitter name, address, contact

Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 845-2000

Contact Person: Jennifer Tribbett

Date Prepared: February 3, 1999

1. Device name The device name, including both the trade/proprietary name and classification name is provided below.

Product Name	Common Name	RegulationNumber	ClassificationName	Class	ProductCode
OnTrak TesTcupM2K and OnTrakTesTstik Controls	Clinical toxicologycontrol material	862.3280	Drug mixturecontrol material	I	DIF

Predicate We claim substantial equivalence to the currently marketed OnTrak device TesTcup/OnTrak TesTstik Controls as well as the Synchron Systems DAT Low Urine Control II and DAT High Urine Control II. The OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control 4) Device Description samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC.

Continued on next page

CONFIDENTIAL

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510(k) Summary, Continued

5. TechnologyCharacteristics	The OnTrak TesTcup M2K/OnTrak TesTstik Controls are prepared by thequantitative addition of drug or drug metabolite to drug-free human urine.Preservatives and stabilizers are added to maintain product integrity.
6. SubstantialEquivalence	The modified OnTrak TesTcup M2K/OnTrak TesTstik Controls aresubstantially equivalent to the currently marketed OnTrak TesTcup/OnTrakTesTstik Controls as well as the Synchron Systems DAT Low Urine ControlII and DAT High Urine Control II.
	The OnTrak TesTcup and TesTstik Control was previously cleared onOctober 9, 1998 (K983387).
	This Premarket Notification [510(k)] is being submitted to the agency due tothe Department of Health and Human Services Substance Abuse and MentalHealth Services Administration's (SAMHSA) revision in the recommendedcutoff for morphine. The cutoff was previously 300 ng/mL, but SAMHSA iscurrently recommending 2000 ng/mL. Therefore, the level of morphine inthe corresponding positive controls must also change to capture the highercutoff value. This notification addresses the change in the positive controlmorphine level from 750 ng/mL to 5000 ng/mL.
	In addition, this notification also addresses the addition of oxazepam as a newconstituent.
	The current cutoff levels for the OnTrak TesTcup and TesTstik assays are:
	Amphetamines: 1000 ng/mLCannabinoids: 50 ng/mLCocaine: 300 ng/mLMorphine: 2000 ng/mLPhencyclidine: 25 ng/mLSecobarbital: 200 ng/mLOxazepam: 200 ng/mL
	A summary of the similarities and differences between the OnTrak TesTcupM2K/OnTrak TesTstik Controls and the predicate products is listed in Table1 and Table 2.

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510(k) Summary, Continued

Table 1

	Modified OnTrak TesTcupM2K and TesTstik Controls		Current OnTrak TesTcupand TesTstik Controls
	Negative	Positive	Negative	Positive
Matrix	Human urine	Human urine	Human urine	Human urine
Drugs:	ng/mL	ng/mL	ng/mL	ng/mL
Amphetamines	0	2500	0	2500
Cannabinoids	0	125	0	125
Cocaine	0	750	0	750
Morphine	0	5000	0	750
Phencyclidine	0	62.5	0	62.5
Secobarbital	0	500	0	500
Oxazepam	0	500	NA	NA

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510(k) Summary, Continued

Substantial The predicate device for the oxazepam constituent is the Beckman Synchron Equivalence systems DAT Low and High Urine Controls II. The table below indicates (Continued) drug concentrations found in the Beckman Controls II.

Beckman Synchron Systems DAT Low and High Urine Controls II
	Low Urine Control II	High Urine Control II
Matrix	Human urine	Human urine
Drugs:	ng/mL	ng/mL
Secobarbital (Barbiturates)	150	300
Oxazepam (Benzodiazepine)	150	300
Methadone	200	375
Methaqualone	200	375
Propoxyphene	200	375

CONFIDENTIAL

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure composed of three curved lines that resemble human profiles. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 26 1999

Jennifer L. Tribbett Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250-0457

K990377 Re:

Trade Name: OnTrack TesTcup M2K and OnTrack TesTstik Positive Control Regulatory Class: I Product Code: DIF Dated: February 3, 1999 Received: February 8, 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device Onder 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) I mis letter will anow you to begin finding of substantial equivalence of your device to a promation hourselicate 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 and additionally 607.10 101 11 10 10 11 11 10 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 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): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup M2K/OnTrak TesTstik Controls

Indications for Use:

-• -•

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_4990377

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

CONFIDENTIAL

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.