510(k) · Cleared

Cleared

Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls

K991733510(k) TraditionalCleared Jul 13, 199953-day reviewClass I21 CFR 862.1475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Schiapparelli Biosystems, Inc. · MRR System, Test, Low Density, Lipoprotein

Cleared on Jul 13, 1999 as substantially equivalent to K971573 (Genzyme Corp., 1997) after a 53-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.

Decided: Jul 13, 1999
Review: 53 days
Class: Class I
Product code: MRR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971573 (1997). 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
This deviceK991733 Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc. · 1999
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
Descendant · cites it directly · 0 of its ownK091333 S-Test LDL Cholesterol (LDL), Model RC0022Alfa Wassermann, Inc. · 2009

Most influential descendants

Showing 4 of 4 · 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
K091333S-Test LDL Cholesterol (LDL), Model RC0022Alfa Wassermann, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971573	N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator…	Genzyme Corp.	1997	—
0 (this device)	K991733	Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls	Schiapparelli Biosystems, Inc.	1999	—
+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	—
+1	K091333	S-Test LDL Cholesterol (LDL), Model RC0022	Alfa Wassermann, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	3	0

FIG. 1 — Lineage of K991733, 1997–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MRR? 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 MRR device

#1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
#2 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K971573	N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL… Summary page 1 …erol Low density lipoprotein cholesterol test Calibrator, Primary Low density lipoprotein cholesterol control Genzyme N-geneous® LDL Cholesterol Reagent [510(k) Number K971573} Genzyme N-geneous® LDL Cholesterol Calibrator Genzyme LDL Control Set The ACE® LDL-C Reagent contains two reagents. An aliquot…	Genzyme Corp.	1997	—

Also cleared against K971573: 6 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113262	Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	2012	1
K112538	Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	2012	0
K091333	S-Test LDL Cholesterol (LDL), Model RC0022	Alfa Wassermann, Inc.	2009	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?

Its one ancestor has no recall.
Of its descendants, K113262 (Alfa Wassermann Diagnostic Technologies, Inc., 2012) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K971573.

How does its category compare?

All MRR devices

MRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRR

1in 2024

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRR

Too few MRR 510(k)s in any year since 2007 to give a median.

Recalls per year · MRR

1in 2025

2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MRR

1in 2024

2007high 3 (2011) · low 0 (2007)2025

MAUDE reports naming product code MRR, 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	0	—	0	0
2008	1	—	2	0
2009	2	—	0	0
2010	0	—	0	0
2011	0	—	0	3
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	1	—	0	3
2018	0	—	1	2
2019	0	—	0	0
2020	0	—	0	1
2021	0	—	0	1
2022	0	—	0	1
2023	1	—	0	1
2024	1	—	0	1
2025	0	—	1	0
2026	0	—	0	—

What is it indicated for?

ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system.

LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay.

LDL-C Controls are intended to monitor the performance of the ACE® LDL-C Assay.

The measurement of LDL cholesterol is a factor in the pathogenesis of atherosclerosis and coronary artery disease.

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/K991733 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991733

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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