510(k) · Cleared
Clearedskyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skyla Corporation H.S.P.B · LCP Assay, Glycosylated Hemoglobin
Cleared on Sep 25, 2018 as substantially equivalent to K151809 (Alere Technologies AS, 2015) after a 361-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 25, 2018
- Review
- 361 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951361 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
- 3 generations backK050574 Afinion HbalcAxis-Shield Poc AS · 2005
- 2 generations backK110056 Afinion AnalyzerAxis-Shield Poc AS · 2011
- 1 generation backK151809 Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS · 2015
- This deviceK173127 skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi…Skyla Corporation H.S.P.B · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951361 | Dca 2000 System for Hemoglobin A1C | Heraeus Kulzer, Inc. | 1995 | 1 |
| −3 | K050574 | Afinion Hbalc | Axis-Shield Poc AS | 2005 | — |
| −2 | K110056 | Afinion Analyzer | Axis-Shield Poc AS | 2011 | — |
| −1 | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | 2015 | — |
| 0 (this device) | K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1… | Skyla Corporation H.S.P.B | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCP device
- #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerSummary page 5…evice Predicate Device Manufacturer 510(k) Number skyla Hi Hemoglobin Alere Afinion Hba1c Alere Technologies AS K151809 A1c System and Alere Afinion AS100 Analyzer IV. DEVICE DESCRIPTION: The skyla Hi Anal… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 4 other devices also cite its predicate K151809.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 2025
MAUDE reports naming product code LCP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 133 | 1 | 5 |
| 2008 | 5 | 206 | 3 | 11 |
| 2009 | 6 | 158 | 6 | 15 |
| 2010 | 2 | — | 5 | 4 |
| 2011 | 10 | 176 | 51 | 27 |
| 2012 | 9 | 143 | 0 | 51 |
| 2013 | 2 | — | 4 | 193 |
| 2014 | 8 | 127 | 2 | 182 |
| 2015 | 3 | 239 | 2 | 64 |
| 2016 | 2 | — | 6 | 29 |
| 2017 | 5 | 218 | 1 | 149 |
| 2018 | 2 | — | 1 | 1,911 |
| 2019 | 4 | 269 | 0 | 114 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 8 |
| 2023 | 2 | — | 0 | 27 |
| 2024 | 1 | — | 1 | 39 |
| 2025 | 0 | — | 1 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173127: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173127
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026