(62 days)
Not Found
No
The device description details a qualitative immunoassay based on chemical reactions and visual interpretation of color bands, with no mention of computational analysis, algorithms, or learning processes.
No
The device is an in vitro diagnostic test for detecting drugs/drug metabolites in urine, not for treating any condition.
Yes
This device is an in vitro test intended for the qualitative detection of drugs or drug metabolites in urine, which directly serves the purpose of providing information about a person's health status (specifically, the presence of certain substances in their system), hence classifying it as a diagnostic device.
No
The device description clearly outlines a physical in vitro diagnostic test cup that utilizes chemical reactions and capillary action to detect drugs in urine. It is a hardware-based device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the OnTrak TesTcup®5 M2K is an "in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The "Device Description" further clarifies that it is an "in vitro test intended for professional use in the qualitative detection of amphetamines... cocaine metabolite... THC... morphine... and PCP." It also describes the mechanism of action, which involves chemical reactions with a biological sample (urine) outside of the body.
- Nature of the Test: The test analyzes a biological specimen (urine) to detect the presence of specific substances (drugs or drug metabolites). This is a hallmark of in vitro diagnostics.
Therefore, based on the provided text, the OnTrak TesTcup-5 M2K clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OnTrak TesTcup®5 M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup-5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites.
The OnTrak TesTcup-5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).
OnTrak TesTcup-5 M2K 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 abuse result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
91LCM
Device Description
The OnTrak TesTcup-5 M2K is an in vitro test intended for professional use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).
The TesTcup 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 in the test chamber.
Urine is collected directly in the OnTrak TesTcup-5 M2K. After closing the cap and moving it to the “TEST” position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band (“negative” sign).
When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white (“positive” sign).
An additional antibody/antigen reaction occurs at the “TEST VALID” area for all assays. The “TEST VALID” blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed 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
OnTrak TesTcup-5 M2K was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at the 25 ng/mL cutoff. All ninety (90) of the PCP positive samples (100%) were positive by OnTrak TesTcup-5 M2K.
Three hundred seven (307) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 25 ng/mL cutoff for PCP were evaluated using OnTrak TesTcup-5 M2K. All three hundred seven (307) were negative for PCP (100%).
All positive and negative samples were also assayed by, and compared to, Abuscreen OnLine for PCP.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PCP Performance: Accuracy
OnTrak TesTcup-5 M2K was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at the 25 ng/mL cutoff. All ninety (90) of the PCP positive samples (100%) were positive by OnTrak TesTcup-5 M2K.
Three hundred seven (307) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 25 ng/mL cutoff for PCP were evaluated using OnTrak TesTcup-5 M2K. All three hundred seven (307) were negative for PCP (100%).
All positive and negative samples were also assayed by, and compared to, Abuscreen OnLine for PCP. Three hundred ninety seven (397) samples by both OnTrak TesTcup-5 M2K and Abuscreen OnLine for PCP demonstrated 100% agreement.
Performance: Precision
95% confidence at 150% cutoff
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
N/A
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: November 24, 1999 | ||
| 2) Device name |
| Product Name | Classification
Name | Product Code | CFR
Classification |
|-------------------------|-----------------------------------------|--------------|-----------------------|
| OnTrak TesTcup-5
M2K | Enzyme
Immunoassay,
Phencyclidine | 91LCM | Unassigned |
- Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTcup-5 M2K (K990337).
1
510(k) Summary, Continued
| 4) Device Description | The OnTrak TesTcup-5 M2K is an in vitro test intended for professional use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). |
|---|---|
| The TesTcup 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 in the test chamber. | |
| Urine is collected directly in the OnTrak TesTcup-5 M2K. After closing the cap and moving it to the “TEST” position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band (“negative” sign). | |
| When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white (“positive” sign). | |
| An additional antibody/antigen reaction occurs at the “TEST VALID” area for all assays. The “TEST VALID” blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed microparticles. | |
| 5. Technology Characteristics | Table 1 shown on the next page outlines the technological characteristics (methodologies) of the modified OnTrak TesTcup-5 M2K in comparison to the predicate device. |
2
510(k) Summary, Continued
Table 1 also provides the results of evaluation studies performed using the 6. Substantial modified OnTrak TesTcup-5 M2K . The significant performance Equivalence characteristics relied upon for a determination of substantial equivalence is summarized in this chart. This information concludes that the performance of the modified OnTrak TesTcup-5 M2K device is substantially equivalent to the predicate device.
Table 1
| Item | OnTrak TesTcup-5 M2K
New PCP Monoclonal Antibody | OnTrak TesTcup-5 M2K
Predicate |
|------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture
inhibition | Same |
| Measurement | Qualitative | Same |
| Sample Type | Urine | Same |
| Endpoint read | Color | Same |
| PCP Cutoff | 25 ng/mL | Same |
| Reagent
(active
ingredients) | •Blue dyed microparticles coated
with mouse monoclonal
antiphencyclidine. | •Blue dyed microparticles
coated with rabbit polyclonal
antiphencyclidine. |
| | •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 |
| Controls | OnTrak TesTcup Positive and
Negative Controls | Same |
| Performance:
Precision | >95% confidence at 150% cutoff | Same |
3
| Item | OnTrak TesTcup-5 M2K
New PCP Monoclonal Antibody | OnTrak TesTcup-5 M2K
Predicate |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PCP
Performance:
Accuracy | OnTrak TesTcup-5 M2K was
evaluated using specimens
screened by an automated
immunoassay and confirmed
positive by GC/MS at the 25
ng/mL cutoff. All ninety (90) of
the PCP positive samples (100%)
were positive by OnTrak
TesTcup-5 M2K.
Three hundred seven (307) urine
samples, obtained from a clinical
laboratory and screened negative
by an automated immunoassay
relative to a 25 ng/mL cutoff for
PCP were evaluated using OnTrak
TesTcup-5 M2K. All three
hundred seven (307) were
negative for PCP (100%)
All positive and negative samples
were also assayed by, and
compared to, Abuscreen OnLine
for PCP. Three hundred ninety
seven (397) samples by both
OnTrak TesTcup-5 M2K and
Abuscreen OnLine for PCP
demonstrated 100% agreement | OnTrak TesTcup-5 M2K was
evaluated using specimens
screened by an automated
immunoassay and confirmed
positive by GC/MS at the 25
ng/mL cutoff. All ninety (90) of
the PCP positive samples
(100%) were positive by
OnTrak TesTcup-5 M2K.
Three hundred seven (307) urine
samples, obtained from a
clinical laboratory and screened
negative by an automated
immunoassay relative to a 25
ng/mL cutoff for PCP were
evaluated using OnTrak
TesTcup-5 M2K. All three
hundred seven (307) were
negative for PCP (100%)
All positive and negative
samples were also assayed by,
and compared to, Abuscreen
OnTrak for PCP. Three hundred
ninety seven (397) samples
tested by both OnTrak TesTcup-
5 M2K and Abuscreen OnTrak
for PCP demonstrated 100% |
Table 1 (Continued)
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 7 2000
Ms. Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K994017 Trade Name: OnTrak TesTcup-5 M2K Regulatory Class: II Product Code: LCM Dated: November 24 1999 Received: November 26, 1999
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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
5
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 Sutman
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
6
510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup-5 M2K
Indications for Use:
OnTrak TesTcup®5 M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup-5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites.
The OnTrak TesTcup-5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).
OnTrak TesTcup-5 M2K 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 abuse result, particularly when preliminary positive results are used.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Cooger
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994017
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)