# K982759: Auto-Lyte Cocaine Metabolite Eia, Model # 1222U

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Nov 20, 1998 after 106 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for usc in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use.

Source page: https://510kreport.com/device/K982759
Methodology: https://510kreport.com/methodology