# K141944: Home Access Aic Test

- Pathway: 510(k) (Traditional)
- Applicant: Home Access Health Corp.
- Decided: Mar 13, 2015 after 239 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: 4 generations back to K861697 (1986). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990899: Hemochek-A1C Sample Collection Kit, Osborn Group, Inc. (1999) Summary page 4.

## Most influential descendants
- K231465: Q-Pad Test System (2023), 0 descendants of its own
- K183230: OneDraw A1C Test System (2019), 0 descendants of its own

## Indications for use
The Home Access® A1C Test is an in vitro test method for the quantitative measurement of Hemoglobin Alc using capillary blood collected from the fingertip, collected onto filter paper via the Home Access collection cassette. The Home Access A1C Test is for measurement of HbAlc on blood specimens which can be collected at the patient's home or in a healthcare professional setting and delivered to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes. This test is not to be used to diagnose or screen for diabetes. Not for use on neonates.

Source page: https://510kreport.com/device/K141944
Methodology: https://510kreport.com/methodology