510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Synchron Systems Cholesterol (Chol) Reagent

K971505510(k) TraditionalCleared Jun 11, 199747-day reviewClass I21 CFR 862.1175Recalls 1

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

Beckman Instruments, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol

Cleared on Jun 11, 1997 as substantially equivalent to K934046 (Beckman-Diagnostic Systems Group, 1993) and 7 other predicates after a 47-day review. Its family tree reaches back 2 generations to 1988. It has been recalled once.

Decided
Jun 11, 1997
Review
47 days
Class
Class I
Product code
CHH
Recalls
1
Predicates
8

Its longest line of descent runs back 2 generations to K883181 (1988). 10 ancestors in all, the oldest K881498 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1993: 2 other ancestors1990: 2 other ancestors1988: 2 other ancestors1994: 1 other ancestorK883181 · Synchron CX4/CX5 Clinical Chemistry Analyzer Reage · Beckman Instruments, Inc. · 1988 · recalledK965240 · Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L · Beckman Instruments, Inc. · 1997 · recalled1986198819901992199419961998
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor K965240 · Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L · Beckman Instruments, Inc. · 1997 · recalledK883181 · Synchron CX4/CX5 Clinical Chemistry Analyzer Reage · Beckman Instruments, Inc. · 1988 · recalled0
  1. Root · 2 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
  2. 1 generation backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
  3. This deviceK971505 Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K883181Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc.19882
−1K965240Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent…Beckman Instruments, Inc.199712
0 (this device)K971505Synchron Systems Cholesterol (Chol) ReagentBeckman Instruments, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198820
199020
199320
199410
199510
FIG. 1 — Lineage of K971505, 1988–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K934046Beckman Cholesterol Reagent
Summary page 2
…) Reagent Summary of Safety & Effectiveness 4.0 Predicate Device(s): SYNCHRON Predicate Predicate Docket Reagent Company Number SYNCHRON Systems | SYNCHRON CX Beckman K934046 Cholesterol (CHOL) Systems Cholesterol Instruments, Inc. Reagent (CHOL) Reagent SYNCHRON ASTRA & Beckman K881498 CX4/CX5 Systems…
Beckman-Diagnostic Systems Group1993—
*K881498Synchron CX (TM)4 Clinical Analyzer
Summary page 2
…t Company Number SYNCHRON Systems | SYNCHRON CX Beckman K934046 Cholesterol (CHOL) Systems Cholesterol Instruments, Inc. Reagent (CHOL) Reagent SYNCHRON ASTRA & Beckman K881498 CX4/CX5 Systems SYNCHRON CX3 Instruments, Inc K881495 SYNCHRON CX5CE | SYNCHRON Beckman K926060 System CX4/CX5 Systems Instrument…
Beckman Instruments, Inc.19881
*K881495Synchron CX (TM)5 Clinical Analyzer
Summary page 2
…an K934046 Cholesterol (CHOL) Systems Cholesterol Instruments, Inc. Reagent (CHOL) Reagent SYNCHRON ASTRA & Beckman K881498 CX4/CX5 Systems SYNCHRON CX3 Instruments, Inc K881495 SYNCHRON CX5CE | SYNCHRON Beckman K926060 System CX4/CX5 Systems Instruments, Inc SYNCHRON SYNCHRON Beckman K904220 CX4CE/C).(7 S…
Beckman Instruments, Inc.19881
*K926060Synchron CX5CE Clinical Analyzer
Summary page 2
…esterol Instruments, Inc. Reagent (CHOL) Reagent SYNCHRON ASTRA & Beckman K881498 CX4/CX5 Systems SYNCHRON CX3 Instruments, Inc K881495 SYNCHRON CX5CE | SYNCHRON Beckman K926060 System CX4/CX5 Systems Instruments, Inc SYNCHRON SYNCHRON Beckman K904220 CX4CE/C).(7 System CX4/CX5 Systems Instruments, Inc K90…
Beckman Instruments, Inc.19932
*K904220Synchron CX4-CE
Summary page 2
…K881498 CX4/CX5 Systems SYNCHRON CX3 Instruments, Inc K881495 SYNCHRON CX5CE | SYNCHRON Beckman K926060 System CX4/CX5 Systems Instruments, Inc SYNCHRON SYNCHRON Beckman K904220 CX4CE/C).(7 System CX4/CX5 Systems Instruments, Inc K904219 SYNCHRON Systems | SYNCHRON Systems | Beckman K950958 CX4/CX5 Systems…
Beckman19901
*K904219Synchron CX 7 Clinical Analyzer
Summary page 2
…5 SYNCHRON CX5CE | SYNCHRON Beckman K926060 System CX4/CX5 Systems Instruments, Inc SYNCHRON SYNCHRON Beckman K904220 CX4CE/C).(7 System CX4/CX5 Systems Instruments, Inc K904219 SYNCHRON Systems | SYNCHRON Systems | Beckman K950958 CX4/CX5 Systems CX4/CX5 Systems Instruments, Inc SYNCHRON LX 20 SYNCHRON CX…
Beckman1990—
*K950958Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta)
Summary page 2
…/CX5 Systems Instruments, Inc SYNCHRON SYNCHRON Beckman K904220 CX4CE/C).(7 System CX4/CX5 Systems Instruments, Inc K904219 SYNCHRON Systems | SYNCHRON Systems | Beckman K950958 CX4/CX5 Systems CX4/CX5 Systems Instruments, Inc SYNCHRON LX 20 SYNCHRON CX7 Beckman K965240 System DELTA System Instruments, Inc…
Beckman Instruments, Inc.19954
*K965240Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX…
Summary page 2
…stems Instruments, Inc K904219 SYNCHRON Systems | SYNCHRON Systems | Beckman K950958 CX4/CX5 Systems CX4/CX5 Systems Instruments, Inc SYNCHRON LX 20 SYNCHRON CX7 Beckman K965240 System DELTA System Instruments, Inc. 5.0 Description: The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNC…
Beckman Instruments, Inc.199712

Also cleared against K934046: 2 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

DateClassRecallRoot causeReason
Nov 10, 2021Class IIZ-0399-2022Nonconforming Material/ComponentCholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 8.5 years on median.
  • 7 of the 10 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K934046.

How does its category compare?

All CHH devices

CHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHH

1in 2025

2007: 22008: 22009: 12011: 12012: 42013: 12014: 12015: 12016: 12017: 12018: 22019: 12022: 12024: 12025: 1
2007high 4 (2012) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CHH

198in 2012

2012: 198 days median
2007high 198 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CHH

2in 2021

2009: 32010: 22013: 12014: 12016: 22021: 22026 (partial year): 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CHH

14in 2025

2007: 12010: 102011: 182012: 112014: 12016: 52017: 22018: 12019: 52020: 12021: 22022: 42023: 42024: 82025: 14
2007high 18 (2011) · low 0 (2008)2025

MAUDE reports naming product code CHH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
20082—00
20091—30
20100—210
20111—018
20124198011
20131—10
20141—11
20151—00
20161—25
20171—02
20182—01
20191—05
20200—01
20210—22
20221—04
20230—04
20241—08
20251—014
20260—1—

What is it indicated for?

The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K934046

2 other devices cite the same predicate.

  • K012221Safe at Home Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2002
  • K011970Biosafe Cholesterol Profile Blood Collection and Transport SystemBiosafe Laboratories, Inc. · 2001

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in CHH

The CHH category page

  • K251091LipidsTruvian Health · 2025
  • K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A · 2024
  • K203597Cholesterol2Abbott Ireland Diagnostics Division · 2022
  • K190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc. · 2019
  • K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018

https://510kreport.com/device/K971505 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971505: Synchron Systems Cholesterol (Chol) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971505

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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