# K022661: A1CNOW for Home Use

- Pathway: 510(k) (Traditional)
- Applicant: Metrika, Inc.
- Decided: Dec 13, 2002 after 126 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 K000885 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020234: A1CNOW for RX Home Use, Metrika, Inc. (2002) Summary page 1.
- K000885: DRX HBA1C - for Prescription Home Use, Metrika, Inc. (2000) Summary page 3.

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

Source page: https://510kreport.com/device/K022661
Methodology: https://510kreport.com/methodology