# K173127: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Skyla Corporation H.S.P.B
- Decided: Sep 25, 2018 after 361 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 skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in venous and finger-stick capillary whole blood. The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus. This system is intended for clinical laboratory and point-of-care use. This test is not for screening or diagnosis of diabetes.

Source page: https://510kreport.com/device/K173127
Methodology: https://510kreport.com/methodology