# K981338: LD-1

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 18, 1998 after 35 days
- Product code: JGF (Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1445
- 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 K894081 (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)
- K894081: Rocho Isomune - LD, Roche Diagnostic Systems, Inc. (1989) Summary page 2.

## Indications for use
The LD-1 assay is used for the quantitation of LD-1 (one of a group of enzymes with similar biological activity) in serum. Measurement of LD-1 is used in the diagnosis and treatment of cardiac diseases, such as myocardial infarction.

Source page: https://510kreport.com/device/K981338
Methodology: https://510kreport.com/methodology