# K072036: Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Mar 19, 2008 after 238 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955851 (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)
- K955851: Axsym Vancomycin II, Abbott Laboratories (1996) Summary page 1.

## Most influential descendants
- K123947: Architect Ivancomycin (2013), 0 descendants of its own

## Recalls of this device
- Sep 13, 2010 · Not classified · Z-0629-2011: The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment.

## Indications for use
The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy. The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.

Source page: https://510kreport.com/device/K072036
Methodology: https://510kreport.com/methodology