# K033674: Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Feb 9, 2004 after 77 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 K972265 (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)
- K011434: G7 Automated HPLC Analyzer, Tosoh Medics, Inc. (2001)

## Indications for use
The MULTIGENT Hb A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent Hb A1c (hemoglobin fraction) in human whole blood on the AEROSET® System and ARCHITECT® c8000™ System. The Hb A1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus. The MULTIGENT Hb A1c assay is not intended for use in diagnosing diabetes mellitus. The MULTIGENT Hb A1c Calibrators are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for the calibration of the assays in the MULTIGENT Hb A1c Reagent Kit. The MULTIGENT Hb A1c Controls are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for quality control of the assays in the MULTIGENT Hb A1c Reagent Kit.

Source page: https://510kreport.com/device/K033674
Methodology: https://510kreport.com/methodology