# K091413: S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG)

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann, Inc.
- Decided: Oct 26, 2009 after 166 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K113809: Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP) (2012), 0 descendants of its own
- K111753: Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride (2011), 0 descendants of its own

## Indications for use
The S-Test Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum or heparin plasma using the S40 Clinical Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The S-Test High Density Lipoprotein Reagent is intended for the quantitative determination of HDL 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 laboratoties or physician office laboratories. For in vitro diagnostic use only. The S-Test Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum or heparin plasma using the S40 Clinical Analyzer. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. 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/K091413
Methodology: https://510kreport.com/methodology