510(k) · Cleared
ClearedIL Test Beta-2MICROGLOBULIN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JZG System, Test, Beta-2-Microglobulin Immunological
Cleared on May 15, 1995 after a 290-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- May 15, 1995
- Review
- 290 days
- Class
- Class II
- Product code
- JZG
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK943686 IL Test Beta-2MICROGLOBULINInstrumentation Laboratory CO · 1995
- Descendant · cites it directly · 0 of its ownK072078 Quantia Beta-2 Microglobulin, Model: 302822307Biokit, S.A. · 2007
- Descendant · cites it directly · 0 of its ownK050613 Quantia Beta-2 MicroglobulinBiokit, S.A. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943686 | IL Test Beta-2MICROGLOBULIN | Instrumentation Laboratory CO | 1995 | — |
| +1 | K072078 | Quantia Beta-2 Microglobulin, Model: 302822307 | Biokit, S.A. | 2007 | — |
| +1 | K050613 | Quantia Beta-2 Microglobulin | Biokit, S.A. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072078 (Biokit, S.A., 2007) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K943686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943686: IL Test Beta-2MICROGLOBULIN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943686
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026