Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a qualitative immunoassay based on microparticle capture inhibition, which is a standard biochemical method and does not involve AI or ML. The summary does not mention any computational analysis or algorithms that would suggest the use of AI/ML.

Therapeutic

No
The device is described as an "in vitro diagnostic "test". Its purpose is to detect the presence of barbiturates or benzodiazepines in urine, and the results are used in "diagnosis and treatment". It does not directly treat or provide therapy to a patient.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test" and that "Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose" and "benzodiazepine use or overdose."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical in vitro diagnostic test kit that uses chemical reactions and capillary action to detect substances in urine, which is a hardware-based process.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicitly Stated in Intended Use/Indications for Use: Both points in the "Intended Use / Indications for Use" section clearly state that the device is an "in vitro diagnostic test."
Explicitly Stated in Device Description: The first sentence of the "Device Description" also states that the devices are "in vitro diagnostic tests."
Purpose of the Test: The test is designed to detect the presence of substances (barbiturates and benzodiazepines) in a biological sample (urine) outside of the body, which is the definition of an in vitro diagnostic test.
Use in Diagnosis and Treatment: The intended use states that the measurements are used in the "diagnosis and treatment" of drug use or overdose, which is a common application for IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1. The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL.
  Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose.
1. The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL.
  Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.

Product codes

DIS, JXM

Device Description

The ONTRAK TESTSTIK Assays for Barbiturates and Benzodiazepines are in vitro diagnostic tests intended for professional use for the qualitative detection of drug in urine at or above a cutoff of 200 ng/mL.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical and nonclinical studies were performed.
For Barbiturates: 50 positive samples identified by Teststik, 50 by Ontrak, 50 by GC/MS. 0 negative samples by Teststik, 0 by Ontrak, 0 by GC/MS. The predicate device identified 48 positive and 0 negative samples by GC/MS.
For Benzodiazepines: 50 positive samples identified by Teststik, 50 by Ontrak, 50 by GC/MS. 0 negative samples by Teststik, 0 by Ontrak, 0 by GC/MS. The predicate device identified 66 positive and 1 negative sample by GC/MS.

The information concludes that the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision: > 95% confidence at 150% cutoff for both Barbiturates and Benzodiazepines.
Predicate devices: > 99% confidence at 200% of cutoff for both Barbiturates and Benzodiazepines.

Predicate Device(s)

K881816/A, K910590

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.3170 Benzodiazepine test system.

(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).

Summary

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Image /page/0/Picture/0 description: The image shows the Roche company logo. The logo consists of the word "Roche" written in a bold, sans-serif font. The word is enclosed in a hexagon shape.

K983174

510(k) Summary

ONTRAK TESTSTIK Assays for Barbiturates & Benzodiazepines

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 September 9, 1998

Contact: Maria Feijoo Manager, Regulatory Affairs Phone: (908) 253-7310 (908) 253-7547 Fax:

1

II. Device Name:

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

Product Name	Classification Name	Regulatory Class
ONTRAK TESTSTIK for
Barbiturates	Barbiturates test
system	Class II	862.3150
ONTRAK TESTSTIK for
Benzodiazepines	Benzodiazepines
test system	Class II	862.3170

Table 1

2

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 | Date
Predicate
Cleared | Predicate
510(k)
Number |
|----------------------------------------|-----------------------------------------|------------------------------|-------------------------------|
| ONTRAK TESTSTIK for
Barbiturates | Abuscreen OnTrak for
Barbiturates | 7/28/88 | K881816/A |
| ONTRAK TESTSTIK for
Benzodiazepines | Abuscreen OnTrak for
Benzodiazepines | 4/05/91 | K910590 |

| 2
7
able

শ	પ
---------------------	---

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

The ONTRAK TESTSTIK Assays for Barbiturates and Benzodiazepines are in vitro diagnostic tests intended for professional use for the qualitative detection of drug in urine at or above a cutoff of 200 ng/mL.

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).

3

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.

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

Tables 3-4 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 3-4 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 chart. This information concludes that the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind.

4

،

| | ONTRAK TESTSTIK
for Barbiturates | | | Abuscreen ONTRAK for
Barbiturates | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Methodology | Competitive microparticle capture
inhibition | | | Competitive latex agglutination
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-
barbiturates
2. Drug conjugates immobilized on a
membrane
3. Mouse monoclonal anti-BSA
antibody immobilized on a
membrane | | | 1. Rabbit anti-barbiturate
antibody in a buffered
solution
2. Reaction buffer
3. Latex-barbiturate conjugate
in a buffered solution | |
| Precision | > 95% confidence at 150% cutoff | | | | > 99% confidence at 200% of
cutoff |
| Accuracy:
Positive Samples | | TesTstik | ONTRAK | GC/MS | GC/MS |
| | + | 50 | 50 | 50 | 48 |
| | - | 0 | 0 | 0 | 0 |

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| | ONTRAK TESTSTIK
for Benzodiazepines | | | Abuscreen ONTRAK for
Benzodiazepines | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Methodology | Competitive microparticle capture
inhibition | | | Competitive latex agglutination
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 sheep polyclonal anti-
benzodiazepine analogue
2. Drug conjugates immobilized on a
membrane
3. Mouse monoclonal anti-BSA
antibody immobilized on a
membrane | | | 1. Mouse monoclonal anti-
benzodiazepine antibody in a
buffered solution
2. Reaction buffer
3. Latex- benzodiazepine
conjugate in a buffered
solution | |
| 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 | 66 |
| | - | 0 | 0 | 0 | 1 |

Table 4 - ONTRAK TESTSTIK for Benzodiazepines

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Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The logo is black and white.

NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Maria Feijoo Manager, Regulatory Affairs Roche Diagnostic System, Inc. 1080 U.S. Highway 202 Somerville, NJ 08876-3771

Re: K983174 Trade Name: OnTrak TesTstik for Barbiturates and OnTrak TesTstik for Benzodiazepines Regulatory Class: II, II Product Code: DIS, JXM Dated: September 9, 1998 Received: September 10, 1998

Dear Ms. Feijoo:

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.

7

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 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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Page 1 of 1

K 983174 510(k) Number (if known)

Device Name: ONTRAK TESTSTIK FOR BARBITURATES ONTRAK TESTSTIK FOR BENZODIAZEPINES

Indications for Use:

1. The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL.
  Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose.
1. The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL.
  Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.

(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)

OR

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

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K983174