# K033659: Varian, Inc. Ontrak Testcup and Ontrak Teststik

- Pathway: 510(k) (Traditional)
- Applicant: Varian, Inc.
- Decided: Jan 6, 2004 after 46 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
OnTrak TesTcup and OnTrak TesTstik products, as listed below, are in vitro diagnostic tests intended for professional use for the qualitative detection of drugs in urine at or above the stated cutoff concentrations. OnTrak TesTcup Products: OnTrak TesTcup 4; OnTrak TesTcup 5; OnTrak TesTcup 5 M2K; OnTrak TesTcup 501; OnTrak TesTcup PRO-5. OnTrak TesTstik Products: OnTrak TesTstik AMP; OnTrak TesTstik BAR; OnTrak TesTstik BNZ; OnTrak TesTstik COC; OnTrak TesTstik MET; OnTrak TesTstik MOR; OnTrak TesTstik PCP; OnTrak TesTstik THC; OnTrak TesTstik 2 COC/THC; OnTrak TesTstik 3 COC/MOR/THC. Cutoff Concentrations: 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 Morphine (M2K) 2000 ng/mL Phencyclidine (PCP) 25 ng/mL Tetrahydrocannabinols (THC) 50 ng/mL OnTrak TesTcup and OnTrak TesTstik products provide only a 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/K033659
Methodology: https://510kreport.com/methodology