# K091544: S-Test Lactate Dehydrogenase (LD), Model RC 0017

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann, Inc.
- Decided: Sep 9, 2009 after 105 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
Longest line of descent: 1 generation back to K931786 (1993). 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)
- K931786: Ace Clinical Chemistry  System, Schiapparelli Biosystems, Inc. (1993) Summary page 1.
- (no number) Alfa Wassermann ACE plus ISE/Clinical Chemistry System: named in the summary without a submission number

## Indications for use
The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K091544
Methodology: https://510kreport.com/methodology