510(k) · Cleared
ClearedAce Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides 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 Oct 5, 2012 as substantially equivalent to K113262 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) after a 28-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Oct 5, 2012
- Review
- 28 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962186 (1996). 6 ancestors in all, the oldest K931786 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK962186 N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp. · 1996
- 2 generations backK971526 Ace HDL-C ReagentSchiapparelli Biosystems, Inc. · 1997
- 1 generation backK113262 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- This deviceK122757 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962186 | N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator | Genzyme Corp. | 1996 | — |
| −2 | K971526 | Ace HDL-C Reagent | Schiapparelli Biosystems, Inc. | 1997 | — |
| −1 | K113262 | Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K113262 | Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentSummary page 2…cal Chemistry System ACE Reagents ACE Cholesterol Reagent (k113262) ACE HDL-C Reagent (kI 13262) ACE LDL-C Reagent (k 113262) ACE Triglycerides Reag… | 2012 |
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 16 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 6 ancestors has a recall.
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 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…
Read the full statement (259 words)
The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration 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 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 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 using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, 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/K122757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122757: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122757
Report an extraction error
Are you the manufacturer?
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