510(k) · Cleared

Cleared

N Antisera to Human ALPHA1-Antitrypsin

K053072510(k) TraditionalCleared Mar 28, 2006147-day reviewClass II21 CFR 866.5130

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

Dade Behring, Inc. · DEM Alpha-1-Antitrypsin, 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. 8 later devices descend from it.

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

Its longest line of descent runs back 1 generation to K860894 (1986). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
This deviceK053072 N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc. · 2006
Descendant · cites it directly · 6 of its ownK063663 Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator…Dade Behring, Inc. · 2007
Descendant · 2 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
Descendant · 2 generations on · 2 of its ownK071980 Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HDade Behring, Inc. · 2007
Descendant · 3 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
Descendant · 3 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007high 4 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all

K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc. · 2007 · cites it directly6descendants
K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 2 generations on4descendants
K071980Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HDade Behring, Inc. · 2007 · 2 generations on2descendants
K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 3 generations on1descendant
K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 3 generations on1descendant

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)	K053072	N Antisera to Human ALPHA1-Antitrypsin	Dade Behring, Inc.	2006	—
+1	K063663	Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and…	Dade Behring, Inc.	2007	—
+2	K072435	Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1…	Dade Behring, Inc.	2007	—
+2	K071980	Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,H	Dade Behring, Inc.	2007	—
+3	K083445	N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control…	Siemens Healthcare Diagnostics	2009	2
+3	K073561	Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…	Dade Behring, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	4	0
2008	2	0
2009	1	0
2023	1	0

FIG. 1 — Lineage of K053072, 1986–2023Source: 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 DEM? 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

Get a 510(k) Report

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: DEM 3. Identification of the Legally Marketed Device: N Antisera to Human ai-Antitrypsin- 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? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063663	Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…	Dade Behring, Inc.	2007	6
K063610	Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…	Dade Behring, Inc.	2007	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, K063663 (Dade Behring, Inc., 2007) has gone furthest, with 6 descendants of its own.
16 other devices also cite its predicate K860894.

How does its category compare?

All DEM devices

DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DEM

1in 2013

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DEM

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

Recalls per year · DEM

1in 2017

2007high 1 (2017) · low 0 (2007)2026

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

Adverse event reports per year · DEM

1in 2024

2007high 1 (2011) · low 0 (2007)2025

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

View these four charts as a table

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

What is it indicated for?

In vitro diagnostic reagents for the quantitative determination of ao-antitrypsin in human serum, heparinized and EDTA plasma by means of immunonephelometery on the BNTM Systems. The measurement of a 1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, al-antitrypsin deficiency has been associated with pulmonary emphysema in conjunction with other laboratory and clinical findings.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053072 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053072: N Antisera to Human ALPHA1-Antitrypsin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053072

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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