510(k) · Cleared
ClearedAce Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent
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 Aug 6, 2012 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 4 other predicates after a 259-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Aug 6, 2012
- Review
- 259 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K951586 (1995). 7 ancestors in all, the oldest K931786 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK951586 T-Uptake Eia TestDiagnostic Reagents, Inc. · 1995
- 1 generation backK981375 Ace T Uptake Reagent TU CalibratorsSchiapparelli Biosystems, Inc. · 1998
- This deviceK113437 Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK131515 Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
Most influential descendants
Showing 1 of 1 · See all- K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951586 | T-Uptake Eia Test | Diagnostic Reagents, Inc. | 1995 | — |
| −1 | K981375 | Ace T Uptake Reagent TU Calibrators | Schiapparelli Biosystems, Inc. | 1998 | — |
| 0 (this device) | K113437 | Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| +1 | K131515 | Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent | Alfa Wassermann | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K931786 | Ace Clinical Chemistry SystemSummary page 2…Product Code DBF Predicate Manufacturer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ACE Reagents (K063306, K98 1375, K98 1377 and K050944) Device The ACE Axcel Clinical… | 1993 |
| * | K063306 | Ace Hemoglobin A1C Reagent, Model Aci-21, Hemoglobin A1C Calibrators, Model S2-72…Summary page 2…ufacturer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ACE Reagents (K063306, K98 1375, K98 1377 and K050944) Device The ACE Axcel Clinical Chemistry System consists of two major component… | 2007 |
| * | K981375 | Ace T Uptake Reagent TU CalibratorsSummary page 2…for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ACE Reagents (K063306, K98 1375, K98 1377 and K050944) Device The ACE Axcel Clinical Chemistry System consists of two major components, Descrip… | 1998 |
| * | K981377 | Ace T4 Reagent T4 CalibratorsSummary page 2…zer/reagent system predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ACE Reagents (K063306, K98 1375, K98 1377 and K050944) Device The ACE Axcel Clinical Chemistry System consists of two major components, Descriptions:… | 1998 |
| * | K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetSummary page 2…ystem predicate: Devices: Alfa Wassermann ACE Clinical Chemistry System (K93 1786) ACE Reagents (K063306, K98 1375, K98 1377 and K050944) Device The ACE Axcel Clinical Chemistry System consists of two major components, Descriptions: the… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131515 | Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent | 2013 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K131515 (Alfa Wassermann, 2013) has gone furthest, with 0 descendants of its own.
- 21 other devices also cite its predicate K931786.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Ale (HbAlIc) Reagent is intended for the quantitative determination of hemoglobin AlIe (pmol/l and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin Ale using the ACE Axcel Clinical Chemistry System. The 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…
Read the full statement (250 words)
ACE Hemoglobin Ale (HbAlIc) Reagent is intended for the quantitative determination of hemoglobin AlIe (pmol/l and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin Ale using the ACE Axcel Clinical Chemistry System. The 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 ACE CEDIA T Uptake homogenous enzyme immunoassay is intended for the quantitative determination of unoccupied binding sties of thyroxine-binding proteins in serum using the ACE Axcel Clinical Chemistry System. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) concentration in serum using the ACE Axcel Clinical Chemistry System. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Ferritin Reagent is intended for the quantitative determination of ferritin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. 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/K113437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113437
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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