# K011933: Glycosal II Hba 1C Test

- Pathway: 510(k) (Traditional)
- Applicant: Provalis Diagnostics, Ltd.
- Decided: Nov 2, 2001 after 135 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) Glycosal™ HbA1c test: named in the summary without a submission number
- (no number) Metrika DRx HbA1c for prescription home use test: named in the summary without a submission number

## Most influential descendants
- K080123: Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201 (2008), 0 descendants of its own

## Indications for use
The Glycosal™ II HbA₁c assay is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA₁c in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for use at home by diabetics as an indicator of overall glycaemic control. The Glycosal™ II HbA₁c assay is intended for prescription home use.

Source page: https://510kreport.com/device/K011933
Methodology: https://510kreport.com/methodology