# K031380: Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog Number ODC3032)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Nov 14, 2003 after 197 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Recalls of this device
- Mar 1, 2011 · Not classified · Z-2170-2011: The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent OSR61177. When HbA1c APT reagent lots 9390 and 9472 are calibrated with HbA1c calibrator OD

## Indications for use
In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers. Measurements obtained through this method can be used for monitoring the long-term care of people with diabetes.

Source page: https://510kreport.com/device/K031380
Methodology: https://510kreport.com/methodology