# K002674: Randox Microalbumin

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Oct 5, 2000 after 38 days
- Product code: DDZ (Albumin, Fitc, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050576: Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H (2005), 0 descendants of its own

## Recalls of this device
- Jan 31, 2024 · Class II · Z-1594-2024: Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient s

Source page: https://510kreport.com/device/K002674
Methodology: https://510kreport.com/methodology