510(k) Report

510(k) · Cleared

Cleared

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

K050576510(k) TraditionalCleared Apr 21, 200545-day reviewClass II21 CFR 866.5040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Good Biotech Corp. · DDZ Albumin, Fitc, Antigen, Antiserum, Control

Cleared on Apr 21, 2005 as substantially equivalent to K002674 (Randox Laboratories, Ltd., 2000) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1995.

Decided
Apr 21, 2005
Review
45 days
Class
Class II
Product code
DDZ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K944664 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK944664 · Wako Micro-Albumin B/Wako Micro Albumin Calibrator · Wako Chemicals USA, Inc. · 1995199619982000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K944664 · Wako Micro-Albumin B/Wako Micro Albumin Calibrator · Wako Chemicals USA, Inc. · 19950
  1. Root · 1 generation backK944664 Wako Micro-Albumin B/Wako Micro Albumin CalibratorWako Chemicals USA, Inc. · 1995
  2. This deviceK050576 Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L…Good Biotech Corp. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944664Wako Micro-Albumin B/Wako Micro Albumin CalibratorWako Chemicals USA, Inc.1995—
0 (this device)K050576Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-HGood Biotech Corp.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K050576, 1995–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DDZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K002674Randox Microalbumin
Summary page 1
…te Device Trade name, Randox Microalbumin Test kit Wako Micro-Albumin B/ Wako Micro Albumin Calibrator 5 10(k) number K002674 K944664 E-1 Description…
Randox Laboratories, Ltd.20001
*K944664Wako Micro-Albumin B/Wako Micro Albumin Calibrator
Summary page 1
…Randox Microalbumin Test kit Wako Micro-Albumin B/ Wako Micro Albumin Calibrator 5 10(k) number K002674 K944664 E-1 Description Good Biotech Corp. Microa…
Wako Chemicals USA, Inc.1995—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.

How does its category compare?

All DDZ devices

DDZ Albumin, Fitc, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DDZ

FDA has decided no DDZ device since 2007.

Median 510(k) review, days · DDZ

Too few DDZ 510(k)s in any year since 2007 to give a median.

Recalls per year · DDZ

No recall names DDZ since 2007.

Adverse event reports per year · DDZ

No MAUDE report names DDZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Good Biotech Corp.

8 FDA decisions under this applicant name. See the company

  • K063766Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-a,CA-0105-a,B,CGood Biotech Corp. · 2007
  • K052617Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO. 7510; Ferritin Controls, Level-L…Good Biotech Corp. · 2006
  • K050713Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set, Catalog Number: 4511Good Biotech Corp. · 2005
  • K022725Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013Good Biotech Corp. · 2002
  • K021757Crpex-BR C-Reactive Protein Lit Assay, Crpex-BR CRP Calibrator SetGood Biotech Corp. · 2002

Recent decisions in DDZ

The DDZ category page

  • K023860Microalbumin Reagent Set and CalibratorsPointe Scientific, Inc., · 2003
  • K002674Randox MicroalbuminRandox Laboratories, Ltd. · 20001 recall
  • K831902Fluorescein Conjugated Immunoglobin-Dako Corp. · 1983

https://510kreport.com/device/K050576 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050576: Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050576

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026