510(k) · Cleared
ClearedAce Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72, Hemoglobin A1C Controls, Model C2-72
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Apr 17, 2007 after a 167-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Apr 17, 2007
- Review
- 167 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK063306 Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C…Alfa Wassermann, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK113437 Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063306 | Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model… | Alfa Wassermann, Inc. | 2007 | — |
| +1 | K113437 | Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| +2 | K131515 | Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent | Alfa Wassermann | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | Tosoh Bioscience, Inc. A1c 2.2 Plus Automated Glycohemoglobin Assay Named without a submission number | |
| * | — | General Atomics, Inc. Hemoglobin A1c Enzymatic Assay Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113437 | Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace… | 2012 | 1 |
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?
- Of its descendants, K113437 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
ACE® Hemoglobin Alc (HbAlc) Reagent is intended for the quantitative determination of hemoglobin Alc (itmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin Alc using the ACE clinical chemistry system. This test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.…
Read the full statement (178 words)
ACE® Hemoglobin Alc (HbAlc) Reagent is intended for the quantitative determination of hemoglobin Alc (itmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin Alc using the ACE clinical chemistry system. This test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.
The pmol HbAlc and total hemoglobin (THb) values generated are intended for use in the calculation of the HbAlc/THb ratio and cannot be used individually for diagnostic purposes.
Hemoglobin Alc Calibrators are intended for use in the performance of both a multi-point calibration for hemoglobin Al c and a single-point calibration of total hemoglobin on the ACE® clinical chemistry system, for the quantitative determination of percent (%) hemoglobin Alc in whole blood. For in vitro diagnostic use only.
Hemoglobin Al c Controls are intended to reliably monitor the accuracy and precision of quantitative determinations of hemoglobin Al c on the ACE® clinical chemistry system. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063306: Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72, Hemoglobin A1C Controls, Model C2-72.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063306
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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