510(k) · Cleared
ClearedAdvia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JZG System, Test, Beta-2-Microglobulin Immunological
Cleared on Jan 20, 2012 as substantially equivalent to K002731 (Dade Behring, Inc., 2000) and 1 other predicate after a 297-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jan 20, 2012
- Review
- 297 days
- Class
- Class II
- Product code
- JZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K992858 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK992858 Abbott Axsym HomocysteineAbbott Laboratories · 1999 · Recalled
- 1 generation backK052788 N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HDade Behring, Inc. · 2006 · Recalled
- This deviceK110874 Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin…Siemens Healthcare Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992858 | Abbott Axsym Homocysteine | Abbott Laboratories | 1999 | 1 |
| −1 | K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H | Dade Behring, Inc. | 2006 | 2 |
| 0 (this device) | K110874 | Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K002731 | N Latex B2-MicroglobulinSummary page 2…n (NB32M) Common name Beta-2-Microglobulin Immunological Test System - Class II 510(k) Number k0027311 Manufacturer Siemens (formerly Dade Behring, Inc) Calibrator Predicate Device… | 2000 |
| * | K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HSummary page 2…ice Device Name Siemens N-protein standard SL Common name Calibrator, multi-analyte mixture 510(k) Number k052788 Manufacturer Siemens (formerly Dade Behring, Inc) Device Description: The AD VIA 1650 Chemistry f32-Micr… | 2006 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K002731.
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?
Reagent: for in vitro diagnostic use in the quantitative determination of β2-microglobulin in human serum or plasma (lithium heparin and potassium EDTA) on ADVIA 1650 Chemistry systems. The ADVIA 1650 Chemistry β2-Microglobulin (B2M) assay aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Calibrator: for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry β2-Microglobulin method
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/K110874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110874: Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110874
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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