510(k) · Cleared
ClearedBeta-2-Microglobulin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter Ireland, Inc. · JZG System, Test, Beta-2-Microglobulin Immunological
Cleared on Jun 7, 2016 as substantially equivalent to K991136 (Olympus America, Inc., 1999) after a 29-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 7, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- JZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991136 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991136 B-2-Microglobulin Immunological Test SystemOlympus America, Inc. · 1999
- This deviceK161297 Beta-2-MicroglobulinBeckman Coulter Ireland, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991136 | B-2-Microglobulin Immunological Test System | Olympus America, Inc. | 1999 | — |
| 0 (this device) | K161297 | Beta-2-Microglobulin | Beckman Coulter Ireland, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K991136 | B-2-Microglobulin Immunological Test SystemSummary page 4…Olympus America Inc./ βeta-2-Microgloublin β-2-Microgloublin K991136 Beckman… | 1999 |
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.
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. 2016, this device’s year, is highlighted.
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?
System reagent for the quantitative determination of β-2-Microglobulin (β2M) in human serum on Beckman Coulter AU analyzers
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/K161297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161297: Beta-2-Microglobulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161297
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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