510(k) · Cleared
ClearedS- Test Hemoglobin Alc (HBA1C), Model RC0023
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Dec 11, 2009 as substantially equivalent to K071466 (Siemens Medical Solutions Diagnostics, 2007) and 1 other predicate after a 184-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 11, 2009
- Review
- 184 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951361 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
- 1 generation backK071466 Dca Vantage, Model 5075Siemens Medical Solutions Diagnostics · 2007 · Recalled
- This deviceK091711 S- Test Hemoglobin Alc (HBA1C), Model RC0023Alfa Wassermann Diagnostic Technologies, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951361 | Dca 2000 System for Hemoglobin A1C | Heraeus Kulzer, Inc. | 1995 | 1 |
| −1 | K071466 | Dca Vantage, Model 5075 | Siemens Medical Solutions Diagnostics | 2007 | 1 |
| 0 (this device) | K091711 | S- Test Hemoglobin Alc (HBA1C), Model RC0023 | Alfa Wassermann Diagnostic Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K071466 | Dca Vantage, Model 5075Summary page 1…ode LCP Predicate Manufacturer for analyzer/reagent system predicate: Devices: Siemens Medical Solutions Diagnostics. DCA Vantage (K071466) and DCA 2000+ Analyzer (K95 1361), Test system for Hemoglobin Alc Device The… | 2007 |
| * | K951361 | Dca 2000 System for Hemoglobin A1CSummary page 1…/reagent system predicate: Devices: Siemens Medical Solutions Diagnostics. DCA Vantage (K071466) and DCA 2000+ Analyzer (K95 1361), Test system for Hemoglobin Alc Device The S-Test Hemoglobin Alec (HbAl c) reagent cartridges, used with t… | 1995 |
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 14 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 4 other devices also cite its predicate K071466.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 S-Test Hemoglobin AlI c Reagent is intended for the quantitative determination of percent Hemoglobin AI c concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091711: S- Test Hemoglobin Alc (HBA1C), Model RC0023.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091711
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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