510(k) Report

510(k) · Cleared

Cleared

Synchron Systems Iron (FE)/Total Iron Binding Capacity Reagents

K960485510(k) TraditionalCleared May 10, 199698-day reviewClass I21 CFR 862.1415

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

Beckman Instruments, Inc. · JMO Ferrozine (Colorimetric) Iron Binding Capacity

Cleared on May 10, 1996 as substantially equivalent to K870986 (Beckman Instruments, Inc., 1987) and 1 other predicate after a 98-day review. Its family tree reaches back 1 generation to 1987.

Decided
May 10, 1996
Review
98 days
Class
Class I
Product code
JMO
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K870986 (1987). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1989: 1 other ancestorK870986 · Liquid-Stat Iron Reagent Kit & Tibc Reagent Kit · Beckman Instruments, Inc. · 19871986198819901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K870986 · Liquid-Stat Iron Reagent Kit & Tibc Reagent Kit · Beckman Instruments, Inc. · 19870
  1. Root · 1 generation backK870986 Liquid-Stat Iron Reagent Kit & Tibc Reagent KitBeckman Instruments, Inc. · 1987
  2. This deviceK960485 Synchron Systems Iron (FE)/Total Iron Binding Capacity ReagentsBeckman Instruments, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K870986Liquid-Stat Iron Reagent Kit & Tibc Reagent KitBeckman Instruments, Inc.1987—
0 (this device)K960485Synchron Systems Iron (FE)/Total Iron Binding Capacity ReagentsBeckman Instruments, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
FIG. 1 — Lineage of K960485, 1987–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 JMO? 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
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What was it cleared against? (2)

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
*K870986Liquid-Stat Iron Reagent Kit & Tibc Reagent Kit
Summary page 1
…ames iron (non-heme) test system (21 CFR 862.140) Iron-binding capacity test system (21 CFR 862.1415) 4.0 Predicate Device(s): SYNCHRON CX System lron (IRON) Reagent, K870986 SYNCHRON CX Systems Total Iron Binding Capacity (TIBC) Reagent, K870986 J&S Medical Associates Micro Column, K893662 50 Descrip…
Beckman Instruments, Inc.1987—
*K893662J&S Iron Saturating Reagents
Summary page 1
…Device(s): SYNCHRON CX System lron (IRON) Reagent, K870986 SYNCHRON CX Systems Total Iron Binding Capacity (TIBC) Reagent, K870986 J&S Medical Associates Micro Column, K893662 50 Description: The SYNCHRON Systems fron (FE) and Total Iron Binding Capacity (IBCT) Reagents are modifications of the current…
J.S. Medical Assoc.1989—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All JMO devices

JMO Ferrozine (Colorimetric) Iron Binding Capacity: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JMO

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JMO

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

Recalls per year · JMO

1in 2012

2008: 12009: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JMO

No MAUDE report names JMO since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20090—10
20100—00
20110—00
20121—10
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The SYNCHRON Systems Iron (FE) and Iron Binding Capacity (IBCT) Reagents, in conjunction with SYNCHRON Systems iron/TIBC Calibrator, are intended for use in the quantitative determination of iron and total iron binding capacity in human serum and plasma samples. These assays are designed for use with the family of SYNCHRON Systems such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

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

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 JMO

The JMO category page

  • K113438Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2012
  • K061464Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668Ortho-Clinical Diagnostics, Inc. · 2006
  • K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 20051 recall
  • K041793Olympus Unsaturated Iron Binding Capcity Reagent, OSR6124/0SR6524Olympus America, Inc. · 20042 recalls
  • K013102Wiener Lab. Fer-Color Transferrina, Model Aux. Reagents for 25 Samples Cat. 1492002Wiener Laboratories Saic · 2001

https://510kreport.com/device/K960485 · printed Nov 3, 2026

Cite this page

510(k) Report. “K960485: Synchron Systems Iron (FE)/Total Iron Binding Capacity Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K960485

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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