Who is the manufacturer of ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595?

Roche Diagnostics Corp. filed the 510(k) submission for ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 (K994165).

What is the FDA product code for ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595?

DIO. It is classified under 21 CFR 862.3250 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595?

OnTrak TesTstik for Cocaine (K973075); OnTrak TesTstik for Morphine (K973075); OnTrak TesTstik for THC (K973075).

Who can help prepare an FDA 510(k) submission like ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595

K994165 · Roche Diagnostics Corp. · DIO · Apr 7, 2000 · Clinical Toxicology

Device Facts

Record ID	K994165
Device Name	ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
Applicant	Roche Diagnostics Corp.
Product Code	DIO · Clinical Toxicology
Decision Date	Apr 7, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3250
Device Class	Class 2

Indications for Use

OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in uripe. The OnTrak TesTstik 3 for Cocaine/Morphine/THC cutoff levels (300 ng/ml for cocaine and morphine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale. OnTrak TesTstik 3 for Cocaine/Morphine/THC provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytices I rosult. Tras chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.) Cluireal consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

In vitro diagnostic test for professional use; detects cocaine metabolite, morphine, and cannabinoids in urine. Principle: competitive microparticle capture inhibition; competition between drugs in urine and drug conjugates immobilized on membrane. Input: urine sample; Output: qualitative color-based visual result. Used in clinical settings by professionals. Provides preliminary results; requires GC/MS confirmation. Clinical decision-making relies on professional judgment alongside preliminary test results.

Clinical Evidence

Clinical evaluation using 70 positive and 100 negative urine specimens. Accuracy demonstrated via comparison to automated immunoassay screening and GC/MS confirmation. Agreement: 94% for cocaine, 94% for morphine, 95% for THC. Precision >95% at 150% of cutoff.

Technological Characteristics

Competitive microparticle capture inhibition assay. Reagents: blue dyed microparticles coated with mouse monoclonal anti-benzoylecgonine, anti-morphine, and anti-cannabinoid antibodies; drug conjugates and mouse monoclonal anti-BSA antibody immobilized on membrane. Qualitative color-based endpoint. Urine sample type.

Indications for Use

Indicated for professional use for qualitative detection of cocaine metabolite, morphine, and cannabinoids in urine. Cutoffs: 300 ng/ml for cocaine/morphine, 50 ng/ml for THC. Not for OTC use. Requires confirmation by alternate method (e.g., GC/MS).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

OnTrak TesTstik for Cocaine (K973075)
OnTrak TesTstik for Morphine (K973075)
OnTrak TesTstik for THC (K973075)

Reference Devices

Abuscreen OnTrak for Cocaine
Abuscreen OnTrak for Morphine
Abuscreen OnTrak for THC

Submission Summary (Full Text)

{0}------------------------------------------------ ### 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. | | | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--| | 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 | | | | | Contact Person: Jennifer Tribbett | Date Prepared: March 6, 2000 | | 2) Device Name The device name, including both the trade/proprietary name and classification name is provided below. | Product Name | Classification Name | Product Code | CFR Classification Name | Predicate Device Name | Date Predicate Cleared | Predicate 510(k) Number | |---------------------------------------------------|----------------------------|-----------------|-------------------------------|------------------------------------|------------------------------|-------------------------------| | OnTrak TesTstik 3 for Cocaine/ Morphine/THC | Cocaine Test System | 91DIO | 862.3250 | OnTrak TesTstik for Cocaine | 10/9/97 | K973075 | | OnTrak TesTstik 3 for Cocaine/ Morphine/THC | Morphine Test System | 91DJJ | 862.3640 | OnTrak TesTstik for Morphine | 10/9/97 | K973075 | | OnTrak TesTstik 3 for Cocaine/ Morphine/THC | Cannabinoid Test System | 91LDJ | 862.3870 | OnTrak TesTstik for THC | 10/9/97 | K973075 | 3) Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTstik for Cocaine (K973075), OnTrak TesTstik for Morphine (K973075) and OnTrak TesTstik for THC (K973075). 4) Device The OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic Description test intended for professional use in the qualitative detection of cocainc metabolite, morphine and cannabinoids in urine at or above a cutoff of 300 ng/ml (cocaine and morphine) and 50 ng/ml (THC). > Like the predicate TesTstik devices, the OnTrak TesTstik 3 is also based on the principles of microparticle capture inhibition. The test relies on the competition between drugs, which may be present in the urine being tested, and drug conjugates immobilized on the membrane. {1}------------------------------------------------ | 5. Technology Characteristics | Tables 1, 2, 3 and 4 outline the technological characteristics (methodologies) of the OnTrak TesTstik 3 for Cocaine/Morphine/THC in comparison to the predicate devices. | | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | 6. Substantial Equivalence | Tables 1, 2, 3 and 4 also provide the significant characteristics relied upon for a determination of substantial equivalence. This information concludes that the performance of the TesTstik 3 for Cocaine/Morphine/THC is substantially equivalent to the currently marketed OnTrak TesTstik Cocaine, OnTrak TesTstik Morphine and OnTrak TesTstik THC. | | | ### TABLE 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Item | OnTrak TesTstik 3 for Cocaine/Morphine/THC New Device | OnTrak TesTstik for Cocaine Predicate | OnTrak TesTstik for Morphine Predicate | OnTrak TesTstik for THC Predicate | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Methodology | Competitive microparticle capture inhibition | Same | Same | Same | | Measurement | Qualitative | Same | Same | Same | | Sample Type | Urine | Same | Same | Same | | Endpoint read | Color | Same | Same | Same | | Cutoff | 300 ng/ml (cocaine) 300ng/ml (morphine) 50 ng/ml (THC) | Same 300 ng/ml (cocaine) | Same 300 ng/ml (morphine) | Same 50 ng/ml (THC) | | Reagent (active ingredients) | • Blue dyed microparticles coated with mouse monoclonal anti- benzoylecgonine antibody, anti-morphine antibody and anti-cannabinoid antibody. | • Blue dyed microparticles coated with mouse monoclonal anti- benzoylecgonine antibody. | • Blue dyed microparticles coated with mouse monoclonal anti- morphine antibody. | • Blue dyed microparticles coated with mouse monoclonal anti- cannabinoid antibody. | | | • Drug conjugates immobilized on a membrane | • Drug conjugates immobilized on a membrane | • Drug conjugates immobilized on a membrane | • Drug conjugates immobilized on a membrane | | | • Mouse monoclonal anti- BSA antibody immobilized on membrane | • Mouse monoclonal anti-BSA antibody immobilized on a membrane | • Mouse monoclonal anti-BSA antibody immobilized on a membrane | • Mouse monoclonal anti-BSA antibody immobilized on a membrane | | Performance: Precision | >95% confidence at 150% cutoff | Same | Same | Same | {2}------------------------------------------------ ## 510K Summary -Continued- ### Table 2 | Item | OnTrak TesTstik 3 for Cocaine/Morphine/THC | OnTrak TesTstik for Cocaine Predicate | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cocaine Performance: Accuracy | OnTrak TesTstik 3 for Cocaine/Morphine/THC was evaluated using clinical specimens screened by an automated immunoassay and confirmed positive by GC/MS. Seventy (70) specimens, including near cutoff specimens, positive for cocaine were evaluated on OnTrak TesTstik 3. One hundred urine specimens were obtained from a clinical laboratory and screened negative by automated immunoassays relative to a 300 ng/ml cutoff for cocaine. A portion (15%) of the negative specimens were also confirmed negative for cocaine by GC/MS. Clinical correlation for all positive (including near cutoff samples) and negative specimens was demonstrated as 94% agreement. | OnTrak TesTstik for Cocaine was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at a 150 ng/ml cutoff. Fifty (50) samples positive for cocaine were positive by OnTrak TesTstik (100%). One hundred six (106) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 300 ng/ml cutoff for cocaine were evaluated and found negative using OnTrak TesTstik. All positive and negative samples were also assayed by, and compared to, Abuscreen OnTrak for Cocaine. All samples demonstrated 100% agreement between the two assays. | {3}------------------------------------------------ # 510K Summary -Continued- | Table 3 | | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | OnTrak TesTstik 3 for Cocaine/Morphine/THC | OnTrak TesTstik for Morphine Predicate | | Morphine Performance: Accuracy | OnTrak TesTstik 3 for Cocaine/Morphine/THC was evaluated using clinical specimens screened by an automated immunoassay and confirmed positive by GC/MS. Seventy (70) specimens, including near cutoff specimens, positive for morphine were evaluated on OnTrak TesTstik 3. | OnTrak TesTstik for Morphine was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at a 300 ng/ml cutoff. Forty nine (49) samples positive for morphine were positive by OnTrak TesTstik (>99%). | | | One hundred urine specimens were obtained from a clinical laboratory and screened negative by automated immunoassays relative to a 300 ng/ml cutoff for morphine. A portion (15%) of the negative specimens were also confirmed negative for opiates (morphine and codeine) by GC/MS. Clinical correlation for all positive (including near cutoff samples) and negative specimens was demonstrated as 94% agreement. | One hundred six (106) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 300 ng/ml cutoff for morphine were evaluated using OnTrak TesTstik. One hundred five (105) were and negative for morphine using OnTrak TesTstik. All positive and negative samples were also assayed by, and compared to, Abuscreen OnTrak for Morphine. One hundred fifty six (156) samples tested by both OnTrak TesTstik and Abuscreen OnTrak for Morphine demonstrated 99.3% agreement. | ## . Table 3 {4}------------------------------------------------ # 510K Summary -Continued- ### Table 4 | Item | OnTrak TesTstik 3 for Cocaine/Morphine/THC | OnTrak TesTstik for THC Predicate | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | THC Performance: Accuracy | | | | | OnTrak TesTstik 3 for Cocaine/Morphine/THC was evaluated using clinical specimens screened by an automated immunoassay and confirmed positive by GC/MS. Seventy (70) specimens, including near cutoff specimens, positive for THC were evaluated on OnTrak TesTstik 3. | OnTrak TesTstik for THC was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at a 15 ng/ml cutoff. Forty five (45) samples positive for THC were positive by OnTrak TesTstik (100%). | | | One hundred urine specimens were obtained from a clinical laboratory and screened negative by automated immunoassays relative to a 50 ng/ml cutoff for THC. A portion (15%) of the negative specimens were also confirmed negative for THC by GC/MS. Clinical correlation for | One hundred six (105) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 50 ng/ml cutoff for THC were evaluated and found negative using OnTrak TesTstik. | | | all positive (including near cutoff samples) and negative specimens was demonstrated as 95% agreement. | All positive and negative samples were also assayed by, and compared to, Abuscreen On Trak for THC. All samples demonstrated 100% agreement between the two assays. | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 7 2000 Ms. Jennifer Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457 Re: K994165 Trade Name: Ontrak TesTstik™ 3 Regulatory Class: II Product Code: DIO, DJJ, LDJ Dated: March 6, 2000 Received: March 7, 2000 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. {6}------------------------------------------------ Page 2 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" (21CFR 807.97). Other gencral 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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 {7}------------------------------------------------ 510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTstik™ 3 for Cocaine/Morphine/THC Indications for Use: OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in uripe. The OnTrak TesTstik 3 for Cocaine/Morphine/THC cutoff levels (300 ng/ml for cocaine and morphine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale. OnTrak TesTstik 3 for Cocaine/Morphine/THC provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytices I rosult. Tras chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.) Cluireal consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory evices 510(k) Number 4994165 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) CONFIDENTIAL

ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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