(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
This device is an in vitro diagnostic test used for the qualitative detection of drugs or drug metabolites in urine, which does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "OnTrak TesTcup® 5 is an in vitro diagnostic test."
No
The device description clearly outlines a physical in vitro diagnostic test cup that utilizes chemical reactions and capillary action on a membrane to detect substances in urine. This involves hardware components and chemical reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states "OnTrak TesTcup® 5 is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine." This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body to provide information about a person's health.
- Device Description: The description details a test that analyzes a biological sample (urine) using chemical reactions (microparticle capture inhibition, antibody/antigen reactions) to detect the presence of specific substances (drugs or drug metabolites). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes performance data based on testing urine samples, which is standard for evaluating the accuracy and reliability of an IVD.
- Predicate Device: The mention of a predicate device (K964355; Roche Diagnostics OnTrak TesTcup 5) further confirms its classification as a medical device, and specifically an IVD given the context.
N/A
Intended Use / Indications for Use
OnTrak TesTcup® 5 is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 simultaneously tests for the presence of multiple drugs or drug metabolites.
The OnTrak TesTcup 5 profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 ng/mL) and PCP (25 ng/mL).
OnTrak TesTcup 5 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
91LCM
Device Description
The OnTrak TesTcup-5 is an in vitro diagnostic test intended for professional use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 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 . 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PCP Performance: Accuracy: OnTrak TesTcup 5 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.
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. 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 tested by both OnTrak TesTcup 5 and Abuscreen OnLine for PCP demonstrated 100% 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
N/A
0
(JAN 2 7 2000
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 | Enzyme
Immunoassay,
Phencyclidine | 91LCM | Unassigned |
- Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTcup 5 (K964355).
ﺗ
1
510(k) Summary, Continued
The OnTrak TesTcup-5 is an in vitro diagnostic test intended for professional 4) Device Description use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 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 . 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. Table 1 shown on the next page outlines the technological characteristics 5. Technology Characteristics (methodologies) of the modified OnTrak TesTcup-5 in comparison to the predicate OnTrak TesTcup 5.
2
510(k) Summary, Continued
Table 1 also provides the results of evaluation studies performed using the 6. Substantial modified OnTrak TesTcup-5 . The significant performance characteristics Equivalence 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 device is substantially equivalent to the predicate device.
Table 1
| Item | OnTrak TesTcup-5
New PCP Monoclonal Antibody | OnTrak TesTcup 5
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.
• Drug conjugates immobilized on a
membrane
• Mouse monoclonal anti-BSA
antibody immobilized on membrane | • Blue dyed microparticles
coated with rabbit polyclonal
antiphencyclidine.
• Drug conjugates immobilized
on a 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
Table 1 (Continued)
| Item | OnTrak TesTcup-5
New PCP Monoclonal
Antibody | OnTrak TesTcup 5
Predicate |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PCP
Performance:
Accuracy | OnTrak TesTcup 5 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. | OnTrak TesTcup 5 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. |
| | 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. All three
hundred seven (307) were
negative for PCP (100%) | 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. 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 tested by
both OnTrak TesTcup 5 and
Abuscreen OnLine for PCP
demonstrated 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 and
Abuscreen OnTrak for PCP
demonstrated 100% agreement. |
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Jan 2 7 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
K994030 Re: Trade Name: OnTrak TesTcup-5 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 (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.
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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup-5
Indications for Use:
OnTrak TesTcup® 5 is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 simultaneously tests for the presence of multiple drugs or drug metabolites.
The OnTrak TesTcup 5 profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 ng/mL) and PCP (25 ng/mL).
OnTrak TesTcup 5 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)
Ocan Coazer
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994030
Prescription Use ﻟﻌﺴﺮ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)