# K051235: ON Trak Testcard

- Pathway: 510(k) (Special)
- Applicant: Varian, Inc.
- Decided: Jun 8, 2005 after 26 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973784 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012396: Ontrak Testcard 9, Roche Diagnostics Corp. (2001) Summary page 1.
- K050321: Ontrak Testcard 9, Varian, Inc. (2005) Summary page 1.

## Indications for use
The OnTrak TesTcard menus are various combinations of the different drugs that are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. It simultaneously tests for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following: Cutoff Concentrations: Amphetamines (d,l-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/mmL PCP (phencyclidine): 25 ng/rmL Tricyclic Antidepressants (TCA)(Imipramine): 1000 ng/mL THC (II -nor-A 9-THC-9-carboxylic acid): 50 ng/mL TesTcard products provide only preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Source page: https://510kreport.com/device/K051235
Methodology: https://510kreport.com/methodology