Predicate Devices

K881817/A,K881815,K882496,K895906,K904856

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a chemical reaction-based qualitative test using microparticle capture inhibition, with no mention of computational analysis, algorithms, or learning processes.

Therapeutic

No
This device is an in vitro diagnostic test for detecting drugs in urine, not for treating any condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" sections explicitly state that the ONTRAK TESTSTIK for Amphetamines, Cocaine, Morphine, PCP, and THC are "in vitro diagnostic tests." The "Device Description" also refers to them as "in vitro diagnostic tests."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical in vitro diagnostic test kit that relies on chemical reactions and capillary action to produce a visual result. There is no mention of software being a component of the device itself.

IVD (In Vitro Diagnostic)

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

The document explicitly states in multiple places that the ONTRAK TESTSTIK assays are "in vitro diagnostic tests intended for professional use". This is the primary indicator that the device falls under the category of IVDs.

Furthermore, the description of the device's mechanism of action (testing urine samples for the presence of specific substances) and the intended use (qualitative detection of drugs or drug metabolites in urine) are consistent with the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.
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.

Product codes

DKZ

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.

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)

The document states that Tables 3-7 demonstrate the results of clinical and nonclinical studies. The performance characteristics reported include Precision and Accuracy for positive samples.
For ONTRAK TESTSTIK for Amphetamines, Precision is stated as > 95% confidence at 150% cutoff. For Accuracy, 50 positive samples were tested by TESTSTIK, and 45 were confirmed by GC/MS. 0 negative samples by TESTSTIK were confirmed by GC/MS, while 1 negative sample by GC/MS was identified as negative by TESTSTIK.
For ONTRAK TESTSTIK for Cocaine, Precision is stated as > 95% confidence at 150% cutoff. For Accuracy, 50 positive samples were tested by TESTSTIK, and 49 were confirmed by GC/MS. 0 negative samples by TESTSTIK correlated with 0 negative samples by GC/MS.
For ONTRAK TESTSTIK for Morphine, Precision is stated as > 95% confidence at 150% cutoff. For Accuracy, 49 positive samples by TESTSTIK correlated with 50 positive by ONTRAK GC/MS.
For ONTRAK TESTSTIK for PCP, Precision is stated as > 95% confidence at 150% cutoff. For Accuracy, 50 positive samples by TESTSTIK correlated with 50 positive by ONTRAK GC/MS; 0 negative samples by TESTSTIK correlated with 0 negative samples by ONTRAK GC/MS. 0 positive by GC/MS were found by TESTSTIK. 0 negative by TESTSTIK were found by GC/MS, while 1 negative by GC/MS was found negative by TESTSTIK.
For ONTRAK TESTSTIK for THC, Precision is stated as > 95% confidence at 150% cutoff. For Accuracy, 45 positive samples by TESTSTIK correlated with 45 positive by ONTRAK GC/MS; 0 negative samples by TESTSTIK correlated with 0 negative samples by ONTRAK GC/MS. 50 samples were run by GC/MS that were not positive by TESTSTIK.

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

Table 3 - ONTRAK TESTSTIK for Amphetamines

Accuracy:
Positive Samples
TesTstik +: 50, GC/MS +: 45
TesTstik -: 0, GC/MS -: 1

Table 4 - ONTRAK TESTSTIK for Cocaine

Accuracy:
Positive Samples
TESTSTIK ONTRAK +: 50, GC/MS +: 49
TESTSTIK ONTRAK -: 0, GC/MS -: 0

Table 5 - ONTRAK TESTSTIK for Morphine

Accuracy:
Positive Samples
TESTSTIK +: 49, ONTRAK GC/MS +: 50

Table 6 - ONTRAK TESTSTIK for PCP

Accuracy:
Positive Samples
TESTSTIK +: 50, ONTRAK GC/MS +: 50
TESTSTIK -: 0, ONTRAK GC/MS -: 1

Table 7 - ONTRAK TESTSTIK for THC

Accuracy:
Positive Samples
TESTSTIK +: 45, ONTRAK GC/MS +: 45
TESTSTIK -: 0, ONTRAK GC/MS -: 0

Predicate Device(s)

K881817/A, K881815, K882496, K895906, K904856

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

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

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.

| Proprietary Name | Predicate Product Name | K number | Date of substantial
equivalence |
|------------------------|-----------------------------------|-----------|------------------------------------|
| 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:

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).

3

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.

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.

4

Table 3 - ONTRAK TESTSTIK for Amphetamines
--------------------------------------------	--	--

| | ONTRAK TESTSTIK
for Amphetamines | Abuscreen ONTRAK for
Amphetamines |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture
inhibition | Competitive latex agglutination
inhibition |
| Measurement | Qualitative | Qualitative |
| Sample type | urine | urine |
| Endpoint read | color | agglutination pattern |
| Cutoff(s) | 1000 ng/mL | 1000 ng/mL |
| Reagent (active
ingredients) | 1. Blue dyed microparticles coated
with mouse monoclonal anti-
amphetamine analogue
2. Drug conjugates immobilized on a
membrane
3. Mouse monoclonal anti-BSA
antibody immobilized on a
membrane | 1. Sheep anti-amphetamine
antibody in a buffered
solution
2. Reaction buffer
3. Latex-amphetamine
conjugate in a buffered
solution |
| Controls | ONTRAK TESTCUP Positive & Negative
Controls | Abuscreen ONTRAK for
Amphetamines Negative Control |
| Performance Characteristics: | | |
| Precision | > 95% confidence at 150% cutoff | > 99% confidence at 200% of
cutoff |
| Accuracy:
Positive Samples | TesTstik | GC/MS |
| + | 50 | 45 |
| - | 0 | 1 |

5

Table 4 - ONTRAK TESTSTIK for Cocaine

| | ONTRAK TESTSTIK
for Cocaine | | Abuscreen ONTRAK for
Cocaine |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture
inhibition | | Competitive latex agglutination
inhibition |
| Measurement | Qualitative | | Qualitative |
| Sample type | urine | | urine |
| Endpoint read | color | | agglutination pattern |
| Cutoff(s) | 300 ng/mL | | 300 ng/mL |
| Reagent (active
ingredients) | 1. Blue dyed microparticles coated
with mouse monoclonal anti-
benzoylecgonine antibody
2. Drug conjugates immobilized on a
membrane
3. Mouse monoclonal anti-BSA
antibody immobilized on a
membrane | | 1. Mouse monoclonal anti-
benzoylecgonine antibody in
a buffered solution
2. Reaction buffer
3. Latex- benzoylecgonine
conjugate in a buffered
solution |
| Controls | ONTRAK TESTCUP Positive & Negative
Controls | | Abuscreen ONTRAK for Cocaine
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 | 49
0 |
| | - | 0
0 | 0
0 |

6

| | ONTRAK TESTSTIK
for Morphine | | Abuscreen ONTRAK for
Morphine |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture
inhibition | | Competitive latex agglutination
inhibition |
| Measurement | Qualitative | | Qualitative |
| Sample type | urine | | urine |
| Endpoint read | color | | agglutination pattern |
| Cutoff(s) | 300 ng/mL | | 300 ng/mL |
| Reagent (active
ingredients) | 1. Blue dyed microparticles coated
with mouse monoclonal anti-
morphine antibody
2. Drug conjugates immobilized on a
membrane
3. Mouse monoclonal anti-BSA
antibody immobilized on a
membrane | | 1. Mouse anti- morphine
antibody in a buffered
solution
2. Reaction buffer
3. Latex-morphine conjugate in
a buffered solution |
| Controls | ONTRAK TESTCUP Positive & Negative
Controls | | Abuscreen ONTRAK for
Morphine Negative Control |
| Performance Characteristics: | | | |
| Precision | > 95% confidence at 150% cutoff | | > 99% confidence at 200% of
cutoff |
| Accuracy:
Positive Samples | | TESTSTIK
49 | ONTRAK GC/MS
50 GC/MS
54 |

0

l

0

Table 5 - ONTRAK TESTSTIK for Morphine

7

Table 6 - ONTRAK TESTSTIK for PCP

| | ONTRAK TESTSTIK
for 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 antibody
2. Drug conjugates immobilized on a membrane
3. Mouse monoclonal anti-BSA antibody immobilized on a membrane | | 1. Rabbit anti- phencyclidine antibody in a buffered solution
2. Reaction buffer
3. 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 |

8

| | ONTRAK TESTSTIK
for THC | Abuscreen ONTRAK for THC | | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|----|
| Methodology | Competitive microparticle capture
inhibition | Competitive latex agglutination
inhibition | | | |
| Measurement | Qualitative | Qualitative | | | |
| Sample type | urine | urine | | | |
| Endpoint read | color | agglutination pattern | | | |
| Cutoff(s) | 50 ng/mL | 50 ng/mL | | | |
| Reagent (active
ingredients) | 1. Blue dyed microparticles coated
with mouse monoclonal anti-
cannabinoid antibody
2. Drug conjugates immobilized on a
membrane
3. Mouse monoclonal anti-BSA
antibody immobilized on a
membrane | 1. Mouse monoclonal anti-
cannabinoid in a buffered
solution
2. Reaction buffer
3. Latex-tetrahydrocannabinoid
conjugate in a buffered
solution | | | |
| Controls | ONTRAK TESTCUP Positive & Negative
Controls | Abuscreen ONTRAK for THC
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 | |
| | + | 45 | 45 | 45 | 50 |
| | - | 0 | 0 | 0 | 0 |

Table 7 - ONTRAK TESTSTIK for THC

9

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.

10

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

11

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) |

------------------------------------------	----	--------------------------------------------------