510(k) · Cleared
ClearedAdvia Chemistry Liquid Specific Protein Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Feb 18, 2011 as substantially equivalent to K031608 (Randox Laboratories, Ltd., 2003) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Feb 18, 2011
- Review
- 60 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031608 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK031608 Randox Liquid Protein CalibratorRandox Laboratories, Ltd. · 2003 · Recalled
- This deviceK103701 Advia Chemistry Liquid Specific Protein CalibratorsSiemens Healthcare Diagnostics, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031608 | Randox Liquid Protein Calibrator | Randox Laboratories, Ltd. | 2003 | 1 |
| 0 (this device) | K103701 | Advia Chemistry Liquid Specific Protein Calibrators | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | K031608 | Randox Liquid Protein CalibratorSummary page 1…x Liquid Protein Calibrators AD VIA Chemistry Liquid Specific Protein Calibrator is substantially equivalent to the Randox Liquid Protein Calibrator cleared under K03 1608 and K06 1056. G. Device Description: AD VIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid buffe… | 2003 |
| * | K061056 | Randox Liquid Protein CalibratorSummary page 1…ein Calibrators AD VIA Chemistry Liquid Specific Protein Calibrator is substantially equivalent to the Randox Liquid Protein Calibrator cleared under K03 1608 and K06 1056. G. Device Description: AD VIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid buffered based pro… | 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?
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of AD VIA® Chemistry systems for the Alpha-Acid-G lycoprote in (AAG), Alpha-i -Antitrypsin (AAT), Ahti-streptolysin-0_2 (ASO -2), Complement 03 (C3), Complement 04 (04), Haptoglobin (HAPT), Immunoglobulin A-2 (IGA-2), Immunoglobulin G-2 (IGG&2), Immunoglobulin M-2 (IGM-2), Prealbumin (PREALB), Rheumatoid Factor (RF), Transferrin (TRF) methods
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103701 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103701: Advia Chemistry Liquid Specific Protein Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103701
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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