# K992634: Immulite Methamphetamine, Model LKMA1, LKMA5

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 20, 2000 after 167 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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 K885071 (1989). 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)
- K885071: Coat-a-Count Methamphetamin #TKMA1, Diagnostic Products Corp. (1989) Summary page 2.

## Indications for use
IMMULITE® Methamphetamine is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and designed for the qualitative measurement of methamphetamine 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 methamphetamine. A cutoff of 500 ng/mL is used by the IMMULITE Methamphetamine assay to identify positive and negative results

Source page: https://510kreport.com/device/K992634
Methodology: https://510kreport.com/methodology