# K180509: Quo-Test A1c System

- Pathway: 510(k) (Dual Track)
- Applicant: Ekf-Diagnostic GmbH
- Decided: Feb 16, 2019 after 354 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 5.

## Indications for use
The Quo-Test A1c System is intended for the in vitro quantitative determination of glycated hemoglobin (%HbA1c) levels in venous whole blood samples (using K2EDTA and lithium heparin anticoagulants). Measurement of percent glycated hemoglobin (%HbA1c) is effective for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus. The Quo-Test A1c System is not intended for screening or diagnosis of diabetes or neonatal use. The device is intended for professional use in a clinical laboratory setting.

Source page: https://510kreport.com/device/K180509
Methodology: https://510kreport.com/methodology