# K955087: Hemoglobin Alc (HBA1C) & Total Assays for the Technicon RA/Opera Systems in-Vitro Diagnostic Systems

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 13, 1996 after 219 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ames DCA 2000 Hemoglobin method: named in the summary without a submission number

## Most influential descendants
- K073309: Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis Reagent (2008), 0 descendants of its own

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure Hemoglobin Alc (HbA1c) and Total Hemoglobin (Thb) in human blood on the Technicon RA family/opeRA instrument systems. Measurements obtained through this procedure can be “used for monitoring the long-term care of persons with diabetes.

Source page: https://510kreport.com/device/K955087
Methodology: https://510kreport.com/methodology