# K033902: Ontrak Testcup II and Onsite Cupkit

- Pathway: 510(k) (Special)
- Applicant: Varian, Inc.
- Decided: Jan 20, 2004 after 34 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: 3 generations back to K964355 (1996). 14 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001421: Ontrak Testcup 501, Model 3016633, Roche Diagnostics Corp. (2000)
- K994017: Ontrak Testcup 5 M2K, Cat. 11 1850 1, Roche Diagnostics Corp. (2000) Summary page 1.
- K983174: Ontrak Teststik for Barbiturates, Ontrak Teststik for Benzodiazepines, Roche Diagnostic Systems, Inc. (1998) Summary page 1.
- K994164: Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579, Roche Diagnostics Corp. (2000) Summary page 1.

## Most influential descendants
- K060896: Modification to Ontrak Testcup II and Onsite Cupkit (2006), 4 descendants of its own
- K153192: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests (2016), 2 descendants of its own
- K232736: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test (2023), 1 descendant of its own
- K252684: Labcorp Fentanyl Urine Visual Test (2026), 0 descendants of its own
- K143599: Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 (2015), 0 descendants of its own

## Indications for use
TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations. Cutoff Concentrations: Amphetamines: 1000 ng/mL Morphine: 300 ng/mL Benzodiazepines: 200 ng/mL Morphine (M2K): 2000 ng/mL Cocaine metabolite: 300 ng/mL Phencyclidine (PCP): 25 ng/mL Methamphetamine: 500 ng/mL Tetrahydrocannabinols (THC): 50 ng/mL TesTcup II and CupKit 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/K033902
Methodology: https://510kreport.com/methodology