# K072143: S40 Clinical Analyzer, S Test Alb

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Jul 14, 2008 after 347 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- 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). 3 ancestors in all.
No later device cites it as a predicate yet.
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.
- K961274: Olympus AU600 Clinical Chemistry Analyzer, Olympus America, Inc. (1996) Summary page 1.
- K942782: Piccolo (TM), Abaxis, Inc. (1995) Summary page 1.

## Indications for use
The S-Test Albumin Reagent is intended for the quantitative determination of albumin concentration in serum or heparin plasma using the S40 Clinical Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver 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/K072143
Methodology: https://510kreport.com/methodology