# K973102: Lidocaine Eia Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Sep 12, 1997 after 24 days
- Product code: KLR (Enzyme Immunoassay, Lidocaine)
- Device class: 2
- Regulation: 21 CFR 862.3555
- 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
This homogeneous lidocaine enzyme immunoassay is intended to be used for quantitative determination of lidocaine in human serum or plasma. Monitoring serum or plasma lidocaine concentration is the most effective means of improving the drug efficacy and minimizing the risk of toxicity for patients under lidocaine treatment for certain cardiac arrhythmias.

Source page: https://510kreport.com/device/K973102
Methodology: https://510kreport.com/methodology