510(k) · Cleared

Cleared

Immunochemistry System Beta-2-Microglobulin Reagent

K973813510(k) TraditionalCleared Nov 20, 199744-day reviewClass II21 CFR 866.5630

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

Beckman Instruments, Inc. · JZG System, Test, Beta-2-Microglobulin Immunological

Cleared on Nov 20, 1997 as substantially equivalent to K940353 (Beckman Instruments, Inc., 1994) after a 44-day review. Its family tree reaches back 1 generation to 1994.

Decided: Nov 20, 1997
Review: 44 days
Class: Class II
Product code: JZG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K940353 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK940353 Beckman Beta-2-Microglobulin (B2M)Beckman Instruments, Inc. · 1994
This deviceK973813 Immunochemistry System Beta-2-Microglobulin ReagentBeckman Instruments, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940353	Beckman Beta-2-Microglobulin (B2M)	Beckman Instruments, Inc.	1994	—
0 (this device)	K973813	Immunochemistry System Beta-2-Microglobulin Reagent	Beckman Instruments, Inc.	1997	—

FIG. 1 — Lineage of K973813, 1994–1997Source: 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 JZG? 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? (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
*	K940353	Beckman Beta-2-Microglobulin (B2M) Summary page 1 …3.2 Classification Name Beta-2-microglobulin immunological test system (21 CFR § 866.5630) Docket \| IMMAGE System Beta- \| Amay Systems Beta-2- Beckman instruments, \| K940353 \| 2-Microglobulin (B2M) Microglobulin(B2M) Inc. Description: The IMMAGE Immunochemistry System B2M Reagent in conjunction with…	Beckman Instruments, Inc.	1994	—

Also cleared against K940353: 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)

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.
2 other devices also cite its predicate K940353.

How does its category compare?

All JZG devices

JZG System, Test, Beta-2-Microglobulin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JZG

1in 2016

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JZG

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

Recalls per year · JZG

1in 2024

2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · JZG

1in 2024

2007high 50 (2015) · low 0 (2007)2025

MAUDE reports naming product code JZG, 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	2	—	0	0
2008	0	—	0	0
2009	2	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	2	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	1	50
2016	1	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	1
2020	0	—	0	0
2021	0	—	1	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	1	1
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin in serum by rate nephelometry.

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/K973813 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973813: Immunochemistry System Beta-2-Microglobulin Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973813

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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