# K192987: Aina HbA1c Monitoring System 2

- Pathway: 510(k) (Traditional)
- Applicant: Jana Care, Inc.
- Decided: Mar 26, 2020 after 153 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 K951361 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151809: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer, Alere Technologies AS (2015) Summary page 4.

## Indications for use
The Aina HbA1c Monitoring System 2 consists of the Aina 2 Automated HbA1c Device, the Aina Device, Aina HbA1c Test Kits, mobile device, and the Aina Mobile Application. It is intended to be used for quantitative measurement of %HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood. It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not intended for use in the diagnosis of or screening for diabetes or for use on neonates.

Source page: https://510kreport.com/device/K192987
Methodology: https://510kreport.com/methodology