# K993131: Nycocard HBA1C Glycosylated Hemoglobin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Primus, Inc.
- Decided: May 22, 2000 after 245 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111128: Labonacheck A1C (2012), 0 descendants of its own

## Indications for use
Measurement of Glycohemoglobin in blood. In vitro diagnostic use only NycoCard HbA Ic is a laboratory test intended for the quantitative determination of percent glycated hemoglobin in whole blood using the system to monitor long term blood glucose control in individuals with diabetes mellitus. Conditions for use: The measurement of glycohemoglobin has not been shown to be reliable in the diagnosis of diabetes mellitus. Such use yields too many false negative and false positive results. (see Lester E. “The clinical value of glycated hemoglobin and glycated plasma proteins”. Ann Clin Biochem 19989;26:213-9)

Source page: https://510kreport.com/device/K993131
Methodology: https://510kreport.com/methodology