# K994020: Ontrak Teststik for PCP, Cat. 07 6654 2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 27, 2000 after 62 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- 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 K881817 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973075: Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on, Roche Diagnostic Systems, Inc. (1997) Summary page 1.

## Indications for use
The Roche Diagnostics Corporation OnTrak TesTstik™ for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of PCP in urine at or above a cutoff concentration of 25 ng/mL OnTrak TesTstik provides 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/K994020
Methodology: https://510kreport.com/methodology