(26 days)
Not Found
No
The device description details a qualitative in vitro diagnostic test based on microparticle capture inhibition and capillary action, with no mention of computational analysis, algorithms, or learning processes.
No
The device is described as an "in vitro diagnostic test" for detecting drugs or drug metabolites in urine, indicating it aids in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine." This clearly indicates its diagnostic purpose.
No
The device description clearly describes a physical in vitro diagnostic test that uses chemical reactions and capillary action on a membrane to detect drugs 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, "The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine." This directly aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
- Device Description: The description details how the device works by analyzing a urine sample (a specimen derived from the human body) to detect the presence of specific substances (drugs or drug metabolites). This process is performed "in vitro" (outside of the body).
- Regulatory Information: The mention of "Prescription Use V (Part 21 CFR 801 Subpart D)" and "Over-The-Counter Use (21 CFR 807 Subpart C)" indicates that this device is subject to FDA regulations for medical devices, including IVDs.
- Predicate Devices: The listing of predicate devices with K numbers (K012396, K050321) further confirms its classification as a medical device, and given its intended use, specifically an IVD.
Therefore, based on the provided information, the OnTrak TesTcard is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OnTrak TesTcard menus are various combinations of the different drugs hat are listed below. The Tes Icard products are in viro diagnoste tests for the qualitative detection of drug or drug metabolite in human urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following:
Cutoff Concentrations
Amphetamines (d,I-amphetamine): 1000 ng/mL
Barbiturates (secobarbital): 200 ng/mL
Benzodiazepines (oxazepam): 100 ng/mL
Cocaine metabolite (benzoylecgonine): 300 ng/mL
Methamphetamine (d-methamphetamine): 500 ng/mL
Morphine (morphine): 300 ng/mL
PCP (phencyclidine): 25 ng/mL
Tricyclic Antidepressants (TCA)(Imipramine): 1000 ng/mL
THC (11-nor-Δ9-THC-9-carboxylic acid): 50 ng/mL
AND/OR
TesTcard products provide only preliminary analytical test result. A more specific alternate test method must be used in order to obtain a confirmed analytical result.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, DIO, LAF, DJJ, LCM, LFG, LDJ
Device Description
The OnTrak TesTcard assays contained in this submission are in vitro diagnostic tests intended for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of amphetamines (d,l-amphetamine 1000 ng/mL), barbiturates (secobarbital 200 ng/mL), benzodiazepines (oxazepam 100 ng/mL), (benzoylecgonine cocaine metabolite ng/mL). methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), tricyclic antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-A-THC-9-carboxylic acid 50 ng/mL).
The TesTcard 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 contacts the urine sample, the sample is absorbed into the TesTcard 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 conjugates. In the absence of drugs 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 antibody-coated 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 specimen causes the membrane to remain white.
An additional antibody/antigen reaction occurs at the "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
Not Found
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): 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
§ 862.3100 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
JUN 8 - 2005
510(k) Summary
K051235
page 1 of 2
According to the requirements of 21 CFR 807.92, the following Introduction According to the requirements detail to understand the basis for a determination of substantial equivalence.
- Submitter name, address, contact
Varian, Inc. 25200 Commercentre Drive Lake Forest, CA 92630 (949) 770-9381
Contact: Lorna Gamboa
Date Prepared: May 11, 2005
Proprietary Name: OnTrak TesTcard 2) Device Name
Panel: Toxicology
| Panel: Toxicology | |||
|---|---|---|---|
| Classification Name: | Product | ||
| Code | Regulation | ||
| Number | |||
| Enzyme Immunoassay, Amphetamine | DKZ | 862.3100 | |
| Enzyme Immunoassay, Barbiturate | DIS | 862.3150 | |
| Enzyme Immunoassay, Benzodiazepines | JXM | 862.3170 | |
| Enzyme Immunoassay, Cocaine and Cocaine | |||
| Metabolite | DIO | 862.3250 | |
| Fluorometry, Morphine | DJJ | 862.3640 | |
| Enzyme Immunoassay, Phencyclidine | LCM | Unclassified | |
| Enzyme Immunoassay, Cannabinoids | LDJ | 862.3870 | |
| Gas Chromatography, Methamphetamine | LAF | 862.3610 | |
| Radioimmunoassay, Tricyclic Antidepressant | |||
| Drugs | LFG | 862.3910 | |
| 3) Predicate | |||
| Device | We claim substantial equivalence to this currently marketed device: | ||
| On Trak TesTcard 9, K012396, 11/05/2001 | |||
| On Trak TesTcard 9, K050321, 04/18/2005 | |||
| 4) Device | |||
| Description | The OnTrak TesTcard assays contained in this submission are in vitro | ||
| diagnostic tests intended for the qualitative detection of drug or drug | |||
| metabolite in urine. The TesTcard devices simultaneously test for the | |||
| presence of multiple drugs or drug metabolites. The TesTcard profile | |||
| (cutoff) consists of amphetamines (d,l-amphetamine 1000 ng/mL), | |||
| barbiturates (secobarbital 200 ng/mL), benzodiazepines (oxazepam 100 |
Image /page/0/Picture/11 description: The image contains the word "CONFIDENTIAL" in a large, sans-serif font. The letters are outlined, giving them a hollow appearance. The word is horizontally oriented and fills most of the frame.
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K051235
page 2 of 2
(benzoylecgonine cocaine metabolite ng/mL). methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), tricyclic antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-A-THC-9-carboxylic acid 50 ng/mL).
The TesTcard 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 contacts the urine sample, the sample is absorbed into the TesTcard 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 conjugates. In the absence of drugs 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 antibody-coated 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 specimen causes the membrane to remain white.
An additional antibody/antigen reaction occurs at the "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.
All drug test strips contained in the TesTcard products have been 5) Technological previously reviewed by FDA under the 510(k) numbers indicated in Characteristics Section 3 of this summary.
Like the predicate device, TesTcard devices utilize microparticle capture inhibition.
6) Substantial Equivalence
The TesTcard devices have the same intended use and incorporate the same fundamental scientific technology as the predicate device.
| Testcard | Predicate | |
|---|---|---|
| Intended Use | Qualitative detection of drugs in urine | Same |
| Scientific Technology | Microparticle capture inhibition | Same |
| Sample Matrix | Urine | Same |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 8 - 2005
Ms. Lorna Gamboa RA/QA Manager Varian, Inc. 25200 Commercentre Drive Lake Forest, CA 92630
Re: K051235
Trade/Device Name: OnTrak TesTcard™ Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class: Class II
Product Code: DKZ, DIS, JXM, DIO, LAF, DJJ, LCM, LFG, LDJ Dated: May 11, 2005 Received: May 13, 2005
Dear Ms. Gamboa:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) is regars analysis and the Medical Device American Comments, or to commence program to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessfired in a premarket approval application (PMA). alle Costlictic Act (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, merceroro, manov as act include requirements for annual registration, listing of general connols provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (bee acover) in s. Existing major regulations affecting your device It inay be subject to Such additional comiser - Marts 800 to 895. In addition, FDA can be louing in Title 21, Coursements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised mat I Dri 3 issualled or wouldevice complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must or any Federal statutes and regulations adminities or of not limited to: registration and listing (21 comply with an the Free STequirements 801 and 809); and good manufacturing practice and requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will allow you to begin naketing your actrice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. "The I DA miding of our device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you destic specific information and advertising of your device, please contact the Office of In or questions on the promotion and Safety at (240) 276-0484. Also, please note the Vitro Diagnostic Dovec Dranation and Bases to premarket notification" (21CFR Part $07.97). regulation entitled, "Misoranant of Frience on your responsibilities under the Act from the You may ootan other general information on Joan Copyrer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number: | K051233 |
|---|---|
| ---------------- | --------- |
Device Name: __OnTrak TesTcard™
Indications for Use:
The OnTrak TesTcard menus are various combinations of the different drugs hat are listed The On Frax TesTcard menus are various collegnostic tests for the qualitative detection of drug below. The Tes Icard products are in viro diagnoste the resence of multiple drugs or drug of the fictabolite in article (cutoff) consists of the following:
| Cutoff Concentrations | |
|---|---|
| Amphetamines (d,I-amphetamine): | 1000 ng/mL |
| Barbiturates (secobarbital): | 200 ng/mL |
| Benzodiazepines (oxazepam): | 100 ng/mL |
| Cocaine metabolite (benzoylecgonine): | 300 ng/mL |
| Methamphetamine (d-methamphetamine): | 500 ng/mL |
| Morphine (morphine): | 300 ng/mL |
| PCP (phencyclidine): | 25 ng/mL |
| Tricyclic Antidepressants (TCA)(Imipramine): | 1000 ng/mL |
| THC (11-nor-Δ9-THC-9-carboxylic acid): | 50 ng/mL |
AND/OR
TesTcard products provide only preliminary analytical test result. A more specific alternate rest card products provide only porder to obtain a confirmed analytical result.
Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Shutt Clam
Page 1 of 1
Division Sign-Off
Office of In Vitro Diagno Device Evaluation and
510(k) K051235
CONFIDENTIAL