510(k) Report

510(k) · Cleared

Cleared

Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage Immunochemistry System Apolipoprotein B Reagent

K964010510(k) TraditionalCleared Feb 10, 1997126-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

Beckman Instruments, Inc. · MSJ Apolipoproteins

Cleared on Feb 10, 1997 as substantially equivalent to K862019 (Beckman Instruments, Inc., 1986) and 1 other predicate after a 126-day review. Its family tree reaches back 1 generation to 1986.

Decided
Feb 10, 1997
Review
126 days
Class
Class I
Product code
MSJ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K862019 (1986). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1986: 1 other ancestorK862019 · Ics Apolipoprotein a-1 Reagent Test Kit · Beckman Instruments, Inc. · 19861986198819901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K862019 · Ics Apolipoprotein a-1 Reagent Test Kit · Beckman Instruments, Inc. · 19860
  1. Root · 1 generation backK862019 Ics Apolipoprotein a-1 Reagent Test KitBeckman Instruments, Inc. · 1986
  2. This deviceK964010 Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/…Beckman Instruments, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K862019Ics Apolipoprotein a-1 Reagent Test KitBeckman Instruments, Inc.1986—
0 (this device)K964010Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage…Beckman Instruments, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
FIG. 1 — Lineage of K964010, 1986–1997Source: 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.

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  • 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
*K862019Ics Apolipoprotein a-1 Reagent Test Kit
Summary page 1
…protein B Reagent 3.2 Classification Names Lipoprotein test system (21 CFR 862.1475) Predicate Device(s): Beckman Immunochemistry Systems Apolipoprotein A-1 Reagent, K862019 Beckman Immunochemistry Systems Apolipoprotein B Reagent, K 862386 Description: The IMMAGE System Apolipoprotein A-1 (APA) and…
Beckman Instruments, Inc.1986—
*K862386Ics Apolipoprotein B Reagent Test Kit
Summary page 1
…em (21 CFR 862.1475) Predicate Device(s): Beckman Immunochemistry Systems Apolipoprotein A-1 Reagent, K862019 Beckman Immunochemistry Systems Apolipoprotein B Reagent, K 862386 Description: The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE…
Beckman Instruments, Inc.1986—

Also cleared against K862019: 1 other device →

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.
  • 1 other device also cites its predicate K862019.

How does its category compare?

All MSJ devices

MSJ Apolipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSJ

2in 2008

2007: 22008: 2
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSJ

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

Recalls per year · MSJ

No recall names MSJ since 2007.

Adverse event reports per year · MSJ

No MAUDE report names MSJ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20082—00
20090—00
20100—00
20110—00
20120—00
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 IMMAGE Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry 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 K862019

1 other device cites the same predicate.

  • K962294Immage Immunochemistry SystemBeckman Instruments, Inc. · 19962 recalls

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 MSJ

The MSJ category page

  • K072977Diazyme Apolipoprotein a-1 AssayGeneral Atomics · 2008
  • K073488Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxDiazyme Laboratories · 2008
  • K061377Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsPointe Scientific, Inc., · 2007
  • K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and HighDade Behring, Inc. · 2007
  • K9926628 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 20001 recall

https://510kreport.com/device/K964010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964010: Immage Immunochemistry System Apolipoprotein a-1 Reagent (Apa)/ Immage Immunochemistry System Apolipoprotein B Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964010

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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