510(k) · Cleared

Cleared

N Antisera to Human ALPHA2-Macroglobulin

K053073510(k) TraditionalCleared Mar 28, 2006147-day reviewClass II21 CFR 866.5620

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

Dade Behring, Inc. · DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control

Cleared on Mar 28, 2006 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) after a 147-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Mar 28, 2006
Review: 147 days
Class: Class II
Product code: DEB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K860894 (1986). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
This deviceK053073 N Antisera to Human ALPHA2-MacroglobulinDade Behring, Inc. · 2006
Descendant · cites it directly · 0 of its ownK081249 Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860894	Behring Nephelometer System	Behring Diagnostics, Inc.	1986	—
0 (this device)	K053073	N Antisera to Human ALPHA2-Macroglobulin	Dade Behring, Inc.	2006	—
+1	K081249	Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System…	Dade Behring, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K053073, 1986–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DEB? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K860894	Behring Nephelometer System Summary page 1 …Immunology Product Code: DEB 3. Identification of the Legally Marketed Device: N Antisera to Human a2-Macroglobulin- K860894 4. Device Description: Proteins contained in human body fluids form immune complexes in an immunochemical…	Behring Diagnostics, Inc.	1986	—

Also cleared against K860894: 16 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081249	Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…	Dade Behring, Inc.	2008	0

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.
Of its descendants, K081249 (Dade Behring, Inc., 2008) has gone furthest, with 0 descendants of its own.
16 other devices also cite its predicate K860894.

How does its category compare?

All DEB devices

DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DEB

1in 2014

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DEB

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

Recalls per year · DEB

No recall names DEB since 2007.

Adverse event reports per year · DEB

No MAUDE report names DEB since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

In vitro diagnostic reagents for the quantitative determination of a 2-macroglobulin in

human serum and heparinized plasma by means of immunonephelometery on the

BNTM Systems. Measurement of a 2-macroglobulin may aid in the diagnosis of blood

clotting or clot lysis disorders.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053073 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053073: N Antisera to Human ALPHA2-Macroglobulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053073

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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