# K091711: S- Test Hemoglobin Alc (HBA1C), Model RC0023

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Dec 11, 2009 after 184 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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 K951361 (1995). 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)
- K071466: Dca Vantage, Model 5075, Siemens Medical Solutions Diagnostics (2007) Summary page 1.
- K951361: Dca 2000 System for Hemoglobin A1C, Heraeus Kulzer, Inc. (1995) Summary page 1.

## Indications for use
The S-Test Hemoglobin AlI c Reagent is intended for the quantitative determination of percent Hemoglobin AI c concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. 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/K091711
Methodology: https://510kreport.com/methodology