510(k) · Cleared
Recalled · Class II · 2022Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Jan 24, 2014 as substantially equivalent to K042193 (Diazyme Laboratories, 2004) and 1 other predicate after a 262-day review. Its family tree reaches back 2 generations to 2003. It has been recalled 5 times.
- Decided
- Jan 24, 2014
- Review
- 262 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K023763 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK023763 Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsRandox Laboratories, Ltd. · 2003 · Recalled
- 1 generation backK042193 Diazyme Glycated Serum Protein Enzymatic Assay KitDiazyme Laboratories · 2004
- This deviceK131307 Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine…Siemens Healthcare Diagnostics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023763 | Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls | Randox Laboratories, Ltd. | 2003 | 3 |
| −1 | K042193 | Diazyme Glycated Serum Protein Enzymatic Assay Kit | Diazyme Laboratories | 2004 | — |
| 0 (this device) | K131307 | Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
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 LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCP device
- #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K042193 | Diazyme Glycated Serum Protein Enzymatic Assay KitSummary page 2…Diazyme Glycated Serum Protein Assay 2. Common Name: Diazyme Glycated Serum Protein Assay 3. 510() Number k042 193 4. Manufacturer: Diazyme Lbratories Calibrators: 1. Device Name: Randox Fructosamine… | 2004 |
| * | K023763 | Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsSummary page 2…brators: 1. Device Name: Randox Fructosamine Calibrator 2. Common Name: Randox Fructosamine Calibrator 3. 510() Number k023 763 4. Manufacturer: Randox Laboratories, Ltd. G. Intended Use and Indication for Use: ADVIA Chemistry Fruc… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2022 | Class II | Z-0930-2022 | Device Design | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| Sep 22, 2020 | Class II | Z-0101-2021 | Device Design | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results… |
| Sep 22, 2020 | Class II | Z-0102-2021 | Device Design | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results… |
| May 4, 2020 | Class II | Z-2281-2020 | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. |
| May 4, 2020 | Class II | Z-2280-2020 | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 2025
MAUDE reports naming product code LCP, 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 | 7 | 133 | 1 | 5 |
| 2008 | 5 | 206 | 3 | 11 |
| 2009 | 6 | 158 | 6 | 15 |
| 2010 | 2 | — | 5 | 4 |
| 2011 | 10 | 176 | 51 | 27 |
| 2012 | 9 | 143 | 0 | 51 |
| 2013 | 2 | — | 4 | 193 |
| 2014 | 8 | 127 | 2 | 182 |
| 2015 | 3 | 239 | 2 | 64 |
| 2016 | 2 | — | 6 | 29 |
| 2017 | 5 | 218 | 1 | 149 |
| 2018 | 2 | — | 1 | 1,911 |
| 2019 | 4 | 269 | 0 | 114 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 8 |
| 2023 | 2 | — | 0 | 27 |
| 2024 | 1 | — | 1 | 39 |
| 2025 | 0 | — | 1 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA® Chemistry Fructosamine (FRUC) Assay
For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA® Chemistry systems. Measurement of fructosamine is representative of blood glucose levels over the preceding 2-3 weeks, and is useful for monitoring diabetic patients.
ADVIA® Chemistry Fructosamine Calibrator
For in vitro diagnostic use in the calibration of the ADVIA® Chemistry Fructosamine (FRUC) assay on ADVIA® Chemistry systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131307: Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131307
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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