510(k) · Cleared
ClearedAce Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Wassermann Diagnostic Technologies, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Jul 3, 2012 as substantially equivalent to K931786 (Schiapparelli Biosystems, Inc., 1993) and 2 other predicates after a 242-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jul 3, 2012
- Review
- 242 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K962186 (1996). 5 ancestors in all, the oldest K931786 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK962186 N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp. · 1996
- 1 generation backK971526 Ace HDL-C ReagentSchiapparelli Biosystems, Inc. · 1997
- This deviceK113262 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK122757 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962186 | N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator | Genzyme Corp. | 1996 | — |
| −1 | K971526 | Ace HDL-C Reagent | Schiapparelli Biosystems, Inc. | 1997 | — |
| 0 (this device) | K113262 | Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| +1 | K122757 | Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…de CDT Predicate Manufacturer for analyzer/reagent system predicates: Devices: Alfa Wassermann ACE plus ISE/Clinical Chemistry System (K93 1786)' ACE Cholesterol Reagent (K93 1786) ACE HDL-C Reagent (K971 526)… | 1993 |
| * | K971526 | Ace HDL-C ReagentSummary page 2…Wassermann ACE plus ISE/Clinical Chemistry System (K93 1786)' ACE Cholesterol Reagent (K93 1786) ACE HDL-C Reagent (K971 526) ACE LDL-C Reagent (K991733) ACE Triglycerides Reagent (K93 1786) D1evice… | 1997 |
| * | K991733 | Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSummary page 2…786)' ACE Cholesterol Reagent (K93 1786) ACE HDL-C Reagent (K971 526) ACE LDL-C Reagent (K991733) ACE Triglycerides Reagent (K93 1786) D1evice The ACE Axcel Clinical Chemistry Syst… | 1999 |
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 |
|---|---|---|---|
| K122757 | Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent | 2012 | 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 16 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122757 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 21 other devices also cite its predicate K931786.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE…
Read the full statement (267 words)
The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mnellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. 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/K113262 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113262: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113262
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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