(126 days)
Not Found
No
The device description details a lateral flow immunoassay based on microparticle capture inhibition, which is a standard biochemical detection method and does not involve AI or ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is an in vitro diagnostic test used to detect substances (cocaine metabolite and cannabinoids) in urine, not to treat or cure a medical condition.
Yes
The text explicitly states in the "Intended Use / Indications for Use" section that the device is an "in vitro diagnostic test."
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. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine." This directly identifies it as an in vitro diagnostic test.
- Device Description: The description details how the test works by analyzing a biological sample (urine) outside of the body ("in vitro") to detect specific substances (cocaine metabolite and cannabinoids).
- Performance Studies: The document describes studies evaluating the device's performance using clinical specimens, which is typical for IVD devices.
N/A
Intended Use / Indications for Use
OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale.
OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
91DIO, 91LDJ
Device Description
The OnTrak TesTstik 2 Cocaine/THC assay described in this submission is an in vitro test intended for professional use in the qualitative detection of cocaine metabolite and cannabinoids in urine at or above a cutoff concentration of 300 ng/ml (cocaine) and 50 ng/ml (THC). The TesTstik assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane. When the 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 In the absence of drug in the urine, the antibody-coated conjugate. microparticles bind to the drug conjugates and blue bands are formed at the result window ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the micro-particles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A positive sample caused the membrane to remain white. An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the TEST VALID area are viable, and the results are ready to interpret.
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
Cocaine Performance: Accuracy: OnTrak TesTstik 2 for Cocaine/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 2. 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.
THC Performance: Accuracy: OnTrak TesTstik 2 for Cocaine/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 2. 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 all positive (including near cutoff samples) and negative specimens was demonstrated as 95% agreement.
Performance: Precision: >95% confidence at 150% cutoff
Key Metrics
Cocaine Performance: Accuracy: 94% agreement (clinical correlation)
THC Performance: Accuracy: 95% agreement (clinical correlation)
Performance: Precision: >95% confidence at 150% cutoff
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
APR 1 3 2000
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 Contact Person: Jennifer Tribbett Date Prepared: March 20, 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™ 2 for
Cocaine/ THC | Cocaine Test
System | 91DIO | 862.3250 | OnTrak
TesTstik for
Cocaine | 10/9/97 | K973075 |
| OnTrak
TesTstik™ 2 for
Cocaine/ 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) and OnTrak TesTstik for THC (K973075).
1
- Device The OnTrak TesTstik 2 Cocaine/THC assay described in this submission is an Description in vitro test intended for professional use in the qualitative detection of cocaine metabolite and cannabinoids in urine at or above a cutoff concentration of 300 ng/ml (cocaine) and 50 ng/ml (THC).
The TesTstik assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane.
When the 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 In the absence of drug in the urine, the antibody-coated conjugate. microparticles bind to the drug conjugates and blue bands are formed at the result window ("negative" sign).
When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the micro-particles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A positive sample caused the membrane to remain white.
An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the TEST VALID area are viable, and the results are ready to interpret.
5. Technology Tables 1, 2 & 3 on the following pages outline the technological Characteristics characteristics (methodologies) of the OnTrak TesTstik 2 for Cocaine/THC in comparison to the predicate devices.
2
510K Summary -Continued-
Tables 1, 2 & 3 provide the significant characteristics relied upon for a 6. Substantial Equivalence determination of substantial equivalence. This information concludes that the performance of the TesTstik 2 for Cocaine/THC is substantially equivalent to the currently marketed OnTrak TesTstik Cocaine (K973075) and OnTrak TesTstik THC (K973075).
| Item | OnTrak TesTstik 2 for
Cocaine/THC
New Device | OnTrak TesTstik for
Cocaine
Predicate | OnTrak TesTstik for
THC
Predicate |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle
capture inhibition | Same | Same |
| Measurement | Qualitative | Same | Same |
| Sample Type | Urine | Same | Same |
| Endpoint read | Color | Same | Same |
| Cutoff | 300 ng/ml (cocaine)
50 ng/ml (THC) | Same
300 ng/ml (cocaine) | Same
50 ng/ml (THC) |
| Reagent
(active
ingredients) | • Blue dyed microparticles
coated with mouse
monoclonal anti-
benzoylecgonine anti-body
and anti-cannabinoid
antibody. | • Blue dyed microparticles
coated with mouse
monoclonal anti-
benzoylecgonine 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 |
| | • 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 |
| Performance:
Precision | >95% confidence at 150%
cutoff | Same | Same |
TABLE 1
3
510K Summary -Continued-
| Item | OnTrak TesTstik 2 for
Cocaine/THC | OnTrak TesTstik for Cocaine
Predicate |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cocaine
Performance:
Accuracy | OnTrak TesTstik 2 for
Cocaine/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 2. | 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 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. | 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. |
Table 2
4
510K Summary --Continued-
| Item | OnTrak TesTstik 2 for
Cocaine/THC | OnTrak TesTstik for THC
Predicate |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| THC
Performance:
Accuracy | OnTrak TesTstik 2 for
Cocaine/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 2. | 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
all positive (including near cutoff
samples) and negative specimens
was demonstrated as 95%
agreement. | 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 and negative samples
were also assayed by, and
compared to, Abuscreen OnTrak
for THC. All samples
demonstrated 100% agreement
between the two assays. |
Table 3
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2000
Ms. Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis. Indiana 46250-0457
Re: K994164 Trade Name: OnTrak TesTstik™ 2 for Cocaine/THC Regulatory Class: II Product Code: LDJ, DIO Dated: March 7, 2000 Received: March 8, 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
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 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 (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™ 2 for Cocaine/THC
Indications for Use:
OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale.
OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical 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)
Lan sos
(Division Sign-Off)
Division of Clinical Laboratory De 510(k) Number JA
Prescription Use \ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)