# K021532: Advia Centaur and Acs:180 C-Peptide 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951848 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951848: Aia-Pack CPR Assay, Tosoh Medics, Inc. (1996) Summary page 1.

## Most influential descendants
- K082141: Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10 (2008), 0 descendants of its own

## Indications for use
The ACS: 180 and ADVIA Centaur C-peptide calibrators are used for calibrating the ACS: 180 and ADVIA Centaur C-peptide Immunoassays. The ACS: 180 and ADVIA Centaur C-peptide are sandwich, chemiluminescence immunoassay for the quantitative determination of C-peptide in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS: 180 and ADVIA Centaur C-peptide Immunoassays can be used to aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

Source page: https://510kreport.com/device/K021532
Methodology: https://510kreport.com/methodology