# K072356: S-Test CA

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Jun 24, 2008 after 307 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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.
- K946090: Kodak Ektacchem 950IRC Analyzer, Clinical Diagnostic Systems, Inc. (1995) Summary page 1.
- K942782: Piccolo (TM), Abaxis, Inc. (1995) Summary page 1.

## Indications for use
The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). 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/K072356
Methodology: https://510kreport.com/methodology