510(k) · Cleared
ClearedImmage Immunochemistry System Beta-2 Microglobulin Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JZG System, Test, Beta-2-Microglobulin Immunological
Cleared on Nov 25, 1998 as substantially equivalent to K940353 (Beckman Instruments, Inc., 1994) after a 22-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 25, 1998
- Review
- 22 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.
- Root · 1 generation backK940353 Beckman Beta-2-Microglobulin (B2M)Beckman Instruments, Inc. · 1994
- This deviceK983895 Immage Immunochemistry System Beta-2 Microglobulin ReagentBeckman Coulter, Inc. · 1998
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) | K983895 | Immage Immunochemistry System Beta-2 Microglobulin Reagent | Beckman Coulter, Inc. | 1998 | — |
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
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 | Decided |
|---|---|---|---|
| * | K940353 | Beckman Beta-2-Microglobulin (B2M) Our OCR of the scanned summary read K840353, FDA’s number for Pacemaker Pulse Generator W/Electrode (Ross Research, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Array Beta-2-Microglobulin (B2M)”. | 1994 |
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 devicesJZG 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JZG
1in 2024
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 (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry. Clinical Significance: An increase in the concentration of serum beta-2-microglobulin can resuit from an overproduction of the protein by nucleated cells and/or decreased…
Read the full statement (109 words)
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.
Clinical Significance:
An increase in the concentration of serum beta-2-microglobulin can resuit from an overproduction of the protein by nucleated cells and/or decreased clearance by the kidneys. Under normal conditions, beta-2-microglobulin passes readily through the glomerular membrane. Levels of beta-2-microglobulin in serum, therefore, are inversely proportional to glomerular filtration rate (GFR). Measurement of Beta-2-Microglobulin in serum or plasma assists in the diagnosis and management of patients with active rheumatoid arthritis and renal disease.
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/K983895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983895: Immage 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/K983895
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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