# K992632: Immulite Amphetamine, Models LKAM1, LKAM5

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 27, 2000 after 174 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: 1 generation back to K871696 (1987). 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)
- K871696: Double Antibody Amphetamine KAPD1 and KAPD5, Diagnostic Products Corp. (1987) Summary page 2.

## Indications for use
IMMULITE® Amphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and designed for the qualitative measurement of Amphetamine in urine. It is intended strictly for in vitro diagnostic use in clinical laboratories, in the context of a program involving an established confirmatory test for amphetamine. A cutoff of 500 ng/mL is used by the IMMULITE Amphetamine assay to identify positive and negative results

Source page: https://510kreport.com/device/K992632
Methodology: https://510kreport.com/methodology