# K973589: Liquid LDH-L Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Oct 8, 1997 after 16 days
- Product code: CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase)
- Device class: 2
- Regulation: 21 CFR 862.1440
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jul 8, 2011 · Class II · Z-2165-2017: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.

## Indications for use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or plasma. It is intended for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.

Source page: https://510kreport.com/device/K973589
Methodology: https://510kreport.com/methodology