# K974859: Lactane Dehydrogenase-SL Assay, Catalogue Number 327-10, 327-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jan 22, 1998 after 24 days
- Product code: CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase)
- Device class: 2
- Regulation: 21 CFR 862.1440
- 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
For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1). Wacker et.al. (2) published a method for the measurement of lactate dehydrognase (LDH) utilizing lactate as the substrate and nicotinamide adenine dinucleotide (NAD) as the indicator coenzyme. The use of the reverse reaction, pyruvate to lactate (LDH-P), has been described by Wroblewski and LaDue (3). Amador et.al. (4) claim the lactate to pyruvate (LDH-L) method is the method of choice because of the greater linearity of the reaction and improved stability of the reagents involved. The LDH-L reaction has been further studied by Gay et.al. (5) and the optimum reaction conditions outlined. This procedure uses the LDH-L method of Wacker in accordance with the recomendations of the International Federation of Clinical Chemists (6).

Source page: https://510kreport.com/device/K974859
Methodology: https://510kreport.com/methodology