# K012396: Ontrak Testcard 9

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 5, 2001 after 101 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: 1 generation back to K973784 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973784: Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests, Biosite Incorporated (1997) Summary page 1.
- K000096: Ontrak Teststik for Methamphetamine, Cat. 1986686, Roche Diagnostics Corp. (2000) Summary page 1.

## Most influential descendants
- K051235: ON Trak Testcard (2005), 0 descendants of its own

## 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), PCP (25 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.

Source page: https://510kreport.com/device/K012396
Methodology: https://510kreport.com/methodology