# K020234: A1CNOW for RX Home 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.
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
- K022661: A1CNOW for Home Use (2002), 0 descendants of its own

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

Source page: https://510kreport.com/device/K020234
Methodology: https://510kreport.com/methodology