# K021535: Advia Cantaur and Acs:180 Insulin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Jun 27, 2002 after 48 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903628 (1990). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903628: Aia-Pack Iri, Tosoh Corp. (1990) Summary page 1.

## Most influential descendants
- K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10 (2006), 1 descendant of its own
- K171168: VITROS Immunodiagnostic Products Insulin Calibrators (2017), 0 descendants of its own
- K162538: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (2016), 0 descendants of its own

## Recalls of this device
- Apr 5, 2017 · Class II · Z-2086-2017: Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other perfor
- Apr 5, 2017 · Class II · Z-2085-2017: Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other perfor

## Indications for use
The ACS: 180 and ADVIA Centaur Insulin calibrators are used for calibrating the ACS:180 and ADVIA Centaur Insulin Immunoassays. The ACS:180 and ADVIA Centaur Insulin are sandwich, chemiluminescence immunoassay for the quantitative determination of Insulin in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS: 180 and ADVIA Centaur Insulin Immunoassays can be used to aid in the diagnosis and treatment of diabetes mellitus and hypoglycemia.

Source page: https://510kreport.com/device/K021535
Methodology: https://510kreport.com/methodology