510(k) · Cleared

Recalled · 2003

Synchron Systems Direct LDL Chloesterol Reagent and Calibrator

K014103510(k) TraditionalCleared Jan 28, 200246-day reviewClass I21 CFR 862.1475Recalls 1

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

Beckman Coulter, Inc. · MRR System, Test, Low Density, Lipoprotein

Cleared on Jan 28, 2002 as substantially equivalent to K971573 (Genzyme Corp., 1997) after a 46-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.

Decided: Jan 28, 2002
Review: 46 days
Class: Class I
Product code: MRR
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K971573 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
This deviceK014103 Synchron Systems Direct LDL Chloesterol Reagent and CalibratorBeckman Coulter, Inc. · 2002

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)	K014103	Synchron Systems Direct LDL Chloesterol Reagent and Calibrator	Beckman Coulter, Inc.	2002	—

FIG. 1 — Lineage of K014103, 1997–2002Source: 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 …475) Primary calibrator (21 CFR § 862.1150) 4.0 Predicate Device(s): Beckman Coulter Predicate Manufacturer -~ \| ,Qdcket o Namber SYNCHRON® Systems N-Geneous LDL Genzyme K971573 Direct LDL Cholesterol Cholesterol Reagent Corporation* (LDLD) Reagent *Genzyme, Corp., Cambridge, MA 5.0 Description: The SYNCHR…	Genzyme Corp.	1997	—

Also cleared against K971573: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 10, 2003	Not classified	Z-1099-04	Other	Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
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?

The SYNCHRON® Systems Direct LDL Cholesterol (LDLD) Reagent, when used in conjunction with SYNCHRON® Systems LDLD Calibrator, is intended for the quantitative determination of low density lipoprotein cholesterol in serum and plasma on Beckman Coulter’s SYNCHRON Systems by colarimetry. LDL cholesterol is directly related to the risk of developing coronary heart disease. A low HDL/LDL cholesterol ratio is directly related to the risk of developing coronary…

Read the full statement (112 words)

LDL cholesterol is directly related to the risk of developing coronary heart disease. A low HDL/LDL cholesterol ratio is directly related to the risk of developing coronary artery disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering 1:herapy.1

1. “Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detectlian, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel [11)", JAMA, 285:2486 (2001).

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/K014103 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014103: Synchron Systems Direct LDL Chloesterol Reagent and Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014103

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026