# K050321: Ontrak Testcard 9

- Pathway: 510(k) (Traditional)
- Applicant: Varian, Inc.
- Decided: Apr 18, 2005 after 68 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Indications for use
On Trak TesTcard 9 product, 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. On Trak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites at or above the stated concentrations. Cutoff Concentrations: Amphetamines 1000 ng/mL Morphine 300 ng/mL Barbiturates 200 ng/mL Phencyclidine (PCP) 25 ng/mL Benzodiazepines 100 ng/mL Tricyclic Antidepressants (TCA) 1000 ng/mL Cocaine metabolite 300 ng/mL Tetrahydrocannabinols (THC) 50 ng/mL Methamphetamine 500 ng/mL On Trak TesTcard 9 product provides only a preliminary analytical test resutt. 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/K050321
Methodology: https://510kreport.com/methodology