510(k) · Cleared
ClearedN Latex B2-Microglobulin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JZG System, Test, Beta-2-Microglobulin Immunological
Cleared on Nov 20, 2000 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 20, 2000
- Review
- 80 days
- Class
- Class II
- Product code
- JZG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK002731 N Latex B2-MicroglobulinDade Behring, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK110874 Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin…Siemens Healthcare Diagnostics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK083463 Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK063272 Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator…Dade Behring, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012 · cites it directly0descendants
- K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension…Siemens Healthcare Diagnostics · 2009 · cites it directly0descendants
- K063272Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium…Dade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002731 | N Latex B2-Microglobulin | Dade Behring, Inc. | 2000 | — |
| +1 | K110874 | Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| +1 | K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator… | Siemens Healthcare Diagnostics | 2009 | 4 |
| +1 | K063272 | Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control… | Dade Behring, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110874 | Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator | 2012 | 0 |
| K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension… | 2009 | 0 |
| K063272 | Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium… | 2007 | 0 |
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, K110874 (Siemens Healthcare Diagnostics, Inc., 2012) 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/K002731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002731: N Latex B2-Microglobulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002731
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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