# K131307: Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 24, 2014 after 262 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023763 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042193: Diazyme Glycated Serum Protein Enzymatic Assay Kit, Diazyme Laboratories (2004) Summary page 2.
- K023763: Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls, Randox Laboratories, Ltd. (2003) Summary page 2.

## Recalls of this device
- Feb 9, 2022 · Class II · Z-0930-2022: 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: 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. P
- Sep 22, 2020 · Class II · Z-0102-2021: 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. P
- May 4, 2020 · Class II · Z-2281-2020: 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: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

## Indications for use
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.

Source page: https://510kreport.com/device/K131307
Methodology: https://510kreport.com/methodology