510(k) Report

510(k) · Cleared

Cleared

Dakocytomation Beta-2-Microglobulin Kit, Code NO. OA 368

K032692510(k) TraditionalCleared Jan 22, 2004142-day reviewClass II21 CFR 866.5630

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

Dako A/S · JZG System, Test, Beta-2-Microglobulin Immunological

Cleared on Jan 22, 2004 as substantially equivalent to K890421 (Abbott Laboratories, 1989) after a 142-day review. Its family tree reaches back 1 generation to 1989.

Decided
Jan 22, 2004
Review
142 days
Class
Class II
Product code
JZG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K890421 (1989). No later device cites it as a predicate yet.

K890421 · Imx B2-Microglobulin · Abbott Laboratories · 198919851990199520002005
K890421 · Imx B2-Microglobulin · Abbott Laboratories · 19890
  1. Root · 1 generation backK890421 Imx B2-MicroglobulinAbbott Laboratories · 1989
  2. This deviceK032692 Dakocytomation Beta-2-Microglobulin Kit, Code NO. OA 368Dako A/S · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K890421Imx B2-MicroglobulinAbbott Laboratories1989—
0 (this device)K032692Dakocytomation Beta-2-Microglobulin Kit, Code NO. OA 368Dako A/S2004—
FIG. 1 — Lineage of K032692, 1989–2004Source: 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 JZG? 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? (1)

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
*K890421Imx B2-Microglobulin
Summary page 2
…ally equivalent to the predicate device described herein with respect to indications for use, device design, materials, and method of manufacture: IMx B2 Microglobulin - K890421 The predicate device is commercially available and a marketed Class IIdevice indicated for use for the quantitative measurement…
Abbott Laboratories1989—

Also cleared against K890421: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K890421.

How does its category compare?

All JZG devices

JZG System, Test, Beta-2-Microglobulin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JZG

1in 2016

2007: 22009: 22012: 22016: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JZG

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

Recalls per year · JZG

1in 2024

2015: 12021: 12024: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JZG

1in 2024

2015: 502019: 12024: 1
2007high 50 (2015) · low 0 (2007)2025

MAUDE reports naming product code JZG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20080—00
20092—00
20100—00
20110—00
20122—00
20130—00
20140—00
20150—150
20161—00
20170—00
20180—00
20190—01
20200—00
20210—10
20220—00
20230—00
20240—11
20250—00
20260—0—

What is it indicated for?

For in vitro diagnostic use.

DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE ® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

Indications for use as stated in the FDA summary.

Also cleared against K890421

1 other device cites the same predicate.

  • K982471B2-Microglobulin Control Set SerumBoehringer Mannheim Corp. · 1998

More from Dako A/S

2 FDA decisions under this applicant name. See the company

  • K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004

Recent decisions in JZG

The JZG category page

  • K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc. · 2016
  • K122066Human Beta-2 Microglobulin Urine Kit for Use on the SpaplusThe Binding Site Group, Ltd. · 20121 recall
  • K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012
  • K083289Human Beta-2 Microglobulin KitThe Binding Site, Ltd. · 2009
  • K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1…Siemens Healthcare Diagnostics · 20094 recalls

https://510kreport.com/device/K032692 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032692: Dakocytomation Beta-2-Microglobulin Kit, Code NO. OA 368.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032692

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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