(120 days)
Not Found
No
The device description and performance studies indicate a standard immunoassay test based on chemical reactions and visual interpretation, with no mention of AI/ML components or data processing beyond basic qualitative detection.
No
This device is an in vitro diagnostic test for detecting substances in urine, not a device used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the OnTrak TesTstik 3 is an "in vitro diagnostic test" intended for "qualitative detection of cocaine metabolite, morphine, and cannabinoids in urine." This directly indicates its use for diagnostic purposes.
No
The device description explicitly states it is an "in vitro diagnostic test" based on "microparticle capture inhibition," which are physical/chemical processes, not software. The summary describes testing of physical specimens, not software validation.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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 "Device Description" section also reiterates: "The OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use in the qualitative detection of cocainc metabolite, morphine and cannabinoids in urine..."
These statements clearly identify the device as an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
91DIO, 91DJJ, 91LDJ
Device Description
The OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic 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.
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
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.
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. 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.
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. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cocaine Performance: Accuracy: Clinical correlation for all positive (including near cutoff samples) and negative specimens was demonstrated as 94% agreement.
Morphine Performance: Accuracy: Clinical correlation for all positive (including near cutoff samples) and negative specimens was demonstrated as 94% agreement.
THC Performance: Accuracy: Clinical correlation for all positive (including near cutoff samples) and negative specimens was demonstrated as 95% agreement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
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.(b)
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).
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 | |
- 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 |
-
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).
-
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