# K082141: Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10

- Pathway: 510(k) (Abbreviated)
- Applicant: Biokit, S.A.
- Decided: Sep 3, 2008 after 35 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: 2 generations back to K951848 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021532: Advia Centaur and Acs:180 C-Peptide Calibrator, Bayer Diagnostics Corp. (2002) Summary page 1.
- K030452: Bayer Ligand Plus 1, 2, 3 Controls, Bayer Diagnostics Corp. (2003) Summary page 1.

## Indications for use
Calibrators The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine. Controls The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

Source page: https://510kreport.com/device/K082141
Methodology: https://510kreport.com/methodology