# K991483: Abbott Architect Glycated Hemoglobin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 1, 1999 after 187 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: 1 generation back to K851636 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851636: Diamat Glycoslated Hemoglobin Analyzer System, Bio-Rad (1985) Summary page 1.

## Indications for use
The Abbott ARCHITECT™ Glycated Hemoglobin assay is a boronate affinity binding assay intended to measure glycated hemoglobin in human anticoagulated whole blood. Measurement of glycated hemoglobin is used for the management of diabetes mellitus.

Source page: https://510kreport.com/device/K991483
Methodology: https://510kreport.com/methodology