(101 days)
Not Found
No
The device description details a qualitative immunoassay based on microparticle capture inhibition, which is a chemical reaction, not an AI/ML process. There is no mention of AI, ML, or any computational analysis of results beyond visual interpretation of band formation.
No.
Explanation: The device is an in vitro diagnostic test for the qualitative detection of drugs or drug metabolites in urine, and its function is solely for diagnostic purposes, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine."
No
The device description clearly describes a physical in vitro diagnostic test kit that uses chemical reactions and capillary action on a membrane to detect substances in urine. It is a hardware-based test, not software.
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 device is an "in vitro diagnostic test."
- Device Description: The "Device Description" also reiterates that it is an "in vitro test."
- Mechanism: The description of how the test works (using urine samples, antibodies, microparticles, and chemical reactions) is consistent with the principles of in vitro diagnostics, which involve testing samples outside of the body.
- Purpose: The purpose of the device is to detect the presence of substances (drugs or drug metabolites) in a biological sample (urine) to provide information about a person's health status or condition (drug use). This is a core function of IVDs.
N/A
Intended Use / Indications for Use
The Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. OnTrak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), tricyclic antidepressants (TCA-1000 ng/ml) and THC (50 ng/ml).
OnTrak TesTcard 9 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 test result, particularly when preliminary positive results are used.
Product codes
91DKZ, 91DIS, 91JXM, 91DIO, 91LAF, 91DJJ, 91LCM, 91LFG, 91LDJ
Device Description
The OnTrak TesTcard 9 is an in vitro test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), PCP (25 ng/ml), tricyclic antidepressants (1000 ng/ml) and THC (50 ng/ml).
The TesTcard 9 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.
When the TesTcard 9 contacts the urine sample, the sample is absorbed into the TesTcard 9 sample pad. The absorbed sample travels through the reagent strips 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 conjugate. In the absence of drug in the urine, the antibody-coated microparticles bind to the drug conjugates and blue bands are formed in the result areas.
When drugs are present in the specimen, they bind to the respective antibodycoated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive sample causes the membrane to remain white.
An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, 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 valid, 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
health care professionals only
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
NOV 0 5 2001
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 9115 Hague Rd. name, address, Indianapolis, IN 46250 contact (317) 845-2000
Contact Person: Jennifer Tribbett
Date Prepared: October 2, 2001
The device name, including both the trade/proprietary name and classification 2) Device Name name is provided below.
| Product Name | Classification
Name | Product
Code | Regulation
Number | Predicate Device
Name | Date Predicate
Cleared | Predicate
510(k) |
|-------------------|----------------------------------------------|-----------------|----------------------|--------------------------------------|---------------------------|---------------------|
| OnTrak TesTcard 9 | Amphetamines test
system | 91DKZ | 862.3100 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Barbiturates test
system | 91DIS | 862.3150 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Benzodiazepines
test systems | 91JXM | 862.3170 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Cocaine test
systems | 91DIO | 862.3250 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Methamphetamines
test system | 91LAF | 862.3610 | OnTrak TesTstik™
Methamphetamines | 04/26/00 | K000096 |
| OnTrak TesTcard 9 | Morphine test
systems | 91DJJ | 862.3640 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | PCP test systems | 91LCM | Not
Assigned | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Tricyclic
antidepressants test
systems | 91LFG | 862.3910 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Cannabinoid test
systems | 91LDJ | 862.3870 | Triage® Panel | 12/03/97 | K973784 |
1
We claim substantial equivalence to the currently marketed Biosite 3) Predicate Diagnostics Triage® Panel Plus TCA (K973784) and the Roche Diagnostics device Corporation, OnTrak TesTstikTM Methamphetamines (K000096).
The OnTrak TesTcard 9 is an in vitro test intended for use by health care 4) Device professionals only for the qualitative detection of drug or drug metabolites in Description urine. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), PCP (25 ng/ml), tricyclic antidepressants (1000 ng/ml) and THC (50 ng/ml).
The TesTcard 9 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.
When the TesTcard 9 contacts the urine sample, the sample is absorbed into the TesTcard 9 sample pad. The absorbed sample travels through the reagent strips 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 conjugate. In the absence of drug in the urine, the antibody-coated microparticles bind to the drug conjugates and blue bands are formed in the result areas.
When drugs are present in the specimen, they bind to the respective antibodycoated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive sample causes the membrane to remain white.
An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, 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 valid, and the results are ready to interpret.
The TesTcard 9 assays are based on the principle of microparticle capture 5. Technology Characteristics 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.
2
OnTrak TesTcard 9 is substantially equivalent to the currently marketed 6. Substantial Equivalence Biosite Diagnostics Triage® Panel Plus TCA (K973784) and the Roche Diagnostics Corporation, OnTrak TesTstik™ Methamphetamines (K000096). The following table describes the similarities and differences between the devices.
| Item | OnTrak TesTcard 9 | Triage® Panel | OnTrak TesTstik
Methamphetamine |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle
capture inhibition | Competitive binding immunoassay | Same as TesTcard 9 |
| Measurement | Qualitative | Same as TesTcard 9 | Same as TesTcard 9 |
| Sample Type | Urine | Same as TesTcard 9 | Same as TesTcard 9 |
| Cutoff | Amphetamines: 1000 ng/ml
Barbiturates: 200 ng/ml
Benzodiazepines: 100 ng/ml
Cocaine metabolite: 300 ng/ml
Methamphetamine: 500 ng/ml
Morphine: 300 ng/ml
PCP: 25 ng/ml
TCA: 1000 ng/ml
THC: 50 ng/ml | Amphetamines: 1000 ng/ml
Barbiturates: 300 ng/ml
Benzodiazepines: 300 ng/ml
Cocaine: 300 ng/ml
Opiates (Morphine): 300 ng/ml
PCP: 25 ng/ml
TCA: 1000 ng/ml
THC: 50 ng/ml | Methamphetamine: 500 ng/ml |
| Reagent
(active
ingredients) | •Microparticles coated with
mouse monoclonal anti-
amphetamine and anti-
barbiturate analogs,
anti-benzoylecgonine,
anti-methamphetamine,
anti-morphine, anti-
phencylidine, anti-TCA and
anti-cannabinoid, sheep
polyclonal anti-benzodiazepine
analog and BSA in a buffered
solution containing
preservative and dried on a
membrane.
•Drug or drug analog
conjugates immobilized on a
membrane
•Mouse monoclonal anti-BSA
immobilized on membrane | • Mouse monoclonal antibodies
against phencyclidine,
benzodiazepine metabolites,
benzoylecgonine, amphetamines,
THC, morphine, barbiturates and
tricyclic antidepressants
immobilized on a membrane
• Mouse monoclonal antibodies
against phencyclidine,
benzodiazepine metabolites,
benzoylecgonine, amphetamines,
THC, morphine, barbiturates and
tricyclic antidepressants lyophilized
in a protein matrix containing