510(k) · Cleared
Recalled · Class II · 2018Human Beta-2 Microglobulin Urine Kit for Use on the Spaplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · JZG System, Test, Beta-2-Microglobulin Immunological
Cleared on Aug 30, 2012 after a 45-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Aug 30, 2012
- Review
- 45 days
- Class
- Class II
- Product code
- JZG
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2018 | Class II | Z-1301-2018 | Under Investigation by firm | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. |
No ancestor or descendant has a Class I 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. 2012, 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?
The kit is intended for the quantitative in vitro 'determination of beta-2 microglobulin (132M) in human urine using the SPAPLUS analyser, to aid the diagnosis of acive rheumatoid arthritis and kidney disease. The test result is to be used in conjunction with other clinical and laboratory findings
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122066: Human Beta-2 Microglobulin Urine Kit for Use on the Spaplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122066
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026