# K000462: Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94A

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 6, 2000 after 55 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott AxSYM System Phencyclidine II Assay: named in the summary without a submission number

## Most influential descendants
- K163220: Atellica CH Phencyclidine (Pcp) (2017), 1 descendant of its own
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays (2006), 1 descendant of its own
- K222439: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (2023), 0 descendants of its own
- K102045: Dimension Visa HBA1C, Model K3105A (2011), 0 descendants of its own

## Indications for use
The PCP Flex@ reagent cartridge used on the Dimension@clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantative determination of phency(;Iidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.

Source page: https://510kreport.com/device/K000462
Methodology: https://510kreport.com/methodology