# K091333: S-Test LDL Cholesterol (LDL), Model RC0022

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann, Inc.
- Decided: Aug 3, 2009 after 89 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971573 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls, Schiapparelli Biosystems, Inc. (1999) Summary page 1.

## Indications for use
The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. 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/K091333
Methodology: https://510kreport.com/methodology