# K020235: A1CNOW for Professional Use

- Pathway: 510(k) (Special)
- Applicant: Metrika, Inc.
- Decided: Feb 15, 2002 after 23 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The A1cNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbAlc) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes.

Source page: https://510kreport.com/device/K020235
Methodology: https://510kreport.com/methodology