# K042243: Microalbumin Multi-Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Oct 4, 2004 after 46 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072204: Advia Chemistry Microalbumin Calibrators, _2 Calibrators (2007), 0 descendants of its own

## Recalls of this device
- Sep 6, 2006 · Not classified · Z-0536-2007: Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct

## Indications for use
For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine.

Source page: https://510kreport.com/device/K042243
Methodology: https://510kreport.com/methodology