510(k) · Cleared
ClearedAce HDL-C Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on May 21, 1997 as substantially equivalent to K962186 (Genzyme Corp., 1996) after a 23-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- May 21, 1997
- Review
- 23 days
- Class
- Class I
- Product code
- LBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962186 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK962186 N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp. · 1996
- This deviceK971526 Ace HDL-C ReagentSchiapparelli Biosystems, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK113262 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK122757 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK112538 Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012 · cites it directly1descendant
- K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012 · 2 generations on0descendants
- K112538Ace 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 |
|---|---|---|---|---|---|
| −1 | K962186 | N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator | Genzyme Corp. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K122757 | Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
| +1 | K112538 | Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace… | Alfa Wassermann Diagnostic Technologies, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 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 LBS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K962186 | N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorSummary page 1…in cholesterol Classification Name: High density lipoprotein cholesterol test Predicate Device Genzyme Corporation's - N-geneous™ HDL Cholesterol Reagent [510(k) Number K962186] Device Description An aliquot of serum is added to the first reagent which contains a mixture of polymers and polyanions that b… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All LBS devicesLBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBS
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LBS
118in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBS
6in 2025
MAUDE reports naming product code LBS, 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 | 0 |
| 2008 | 3 | 129 | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 3 | 118 | 0 | 3 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum.
Numerous studies have shown an inverse relationship between serum HDL cholesterol and the risk of coronary heart disease. HDL cholesterol also has an important role in the pathogenesis of atherosclerosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971526 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971526: Ace HDL-C Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971526
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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