# K050576: Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H

- Pathway: 510(k) (Traditional)
- Applicant: Good Biotech Corp.
- Decided: Apr 21, 2005 after 45 days
- Product code: DDZ (Albumin, Fitc, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- 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 K944664 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002674: Randox Microalbumin, Randox Laboratories, Ltd. (2000) Summary page 1.
- K944664: Wako Micro-Albumin B/Wako Micro Albumin Calibrator, Wako Chemicals USA, Inc. (1995) Summary page 1.

## Indications for use
Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease. GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples. GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K050576
Methodology: https://510kreport.com/methodology