# K050178: HBA1C Enzymatic Assay

- Pathway: 510(k) (Traditional)
- Applicant: General Atomics
- Decided: Jun 28, 2005 after 153 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K011434: G7 Automated HPLC Analyzer, Tosoh Medics, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
HbAlC Enzymatic Assay is intended for the in vitro quantitative determination of stable HbAlc (glycated hemoglobin Alc; Alc) in human whole blood samples. Measurement of hemoglobin Al C is a valuable indicator for long-term diabetic control.

Source page: https://510kreport.com/device/K050178
Methodology: https://510kreport.com/methodology