# K972963: Modified Cedia Dau PCP Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Sep 22, 1997 after 42 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: 1 generation back to K935650 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935650: Cedia (R) Dau PCP Assay, Microgenics Corp. (1994) Summary page 1.

## Indications for use
The modified CEDIA® DAU PCP Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and semiquantitative assay of PCPs in human urine. Measurements are used as an aid in the diagnosis and treatment of PCP use or overdose.

Source page: https://510kreport.com/device/K972963
Methodology: https://510kreport.com/methodology