510(k) · Cleared
ClearedAdvia Chemistry Microalbumin Calibrators, _2 Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions Diagnostics · JIX Calibrator, Multi-Analyte Mixture
Cleared on Oct 5, 2007 as substantially equivalent to K042243 (Diagnostic Chemicals, Ltd., 2004) after a 58-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Oct 5, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042243 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042243 Microalbumin Multi-Calibrator SetDiagnostic Chemicals, Ltd. · 2004 · Recalled
- This deviceK072204 Advia Chemistry Microalbumin Calibrators, _2 CalibratorsSiemens Medical Solutions Diagnostics · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042243 | Microalbumin Multi-Calibrator Set | Diagnostic Chemicals, Ltd. | 2004 | 1 |
| 0 (this device) | K072204 | Advia Chemistry Microalbumin Calibrators, _2 Calibrators | Siemens Medical Solutions Diagnostics | 2007 | — |
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 JIX? 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 |
|---|---|---|---|
| * | K042243 | Microalbumin Multi-Calibrator SetSummary page 1…________ Predicate Device: Devc Nm DCMirabmin Multi-Calibrator Set Common name Microalbumin Calibrator 510(k) Number k042243 Manufacturer Diagnostic Chemicals Limited Siemens Medical Solutions Diagnostics ADVIA Chemistry Microalbumnin… | 2004 |
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 a recall.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin method (this method is used for in vitro quantitation of albumin in urine).
The ADVIA® Chemistry Microalbumin_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin_2 method (this method is used for in vitro quantitation of albumin in urine).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072204 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072204: Advia Chemistry Microalbumin Calibrators, _2 Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072204
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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