510(k) · Cleared

Cleared

Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)

K964766510(k) TraditionalCleared Apr 25, 1997149-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

Beckman Instruments, Inc. · DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

Cleared on Apr 25, 1997 as substantially equivalent to K771603 (Beckman Instruments, Inc., 1977) after a 149-day review. Its family tree reaches back 1 generation to 1977. 4 later devices descend from it.

Decided: Apr 25, 1997
Review: 149 days
Class: Class II
Product code: DEM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K771603 (1977). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
This deviceK964766 Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Beckman Instruments, Inc. · 1997
Descendant · cites it directly · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
Descendant · 2 generations on · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
Descendant · 3 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013
Descendant · 2 generations on · 0 of its ownK060940 Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2006

Most influential descendants

Showing 4 of 4 · See all

K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · cites it directly3descendants
K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc. · 2006 · 2 generations on1descendant
K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2013 · 3 generations on0descendants
K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K771603	Immochemistry System	Beckman Instruments, Inc.	1977	—
0 (this device)	K964766	Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)	Beckman Instruments, Inc.	1997	—
+1	K052819	Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance…	Ortho-Clinical Diagnostics, Inc.	2005	—
+2	K061588	Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator…	Ortho-Clinical Diagnostics, Inc.	2006	1
+3	K123930	Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance…	Ortho-Clinical Diagnostics, Inc.	2013	—
+2	K060940	Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…	Ortho-Clinical Diagnostics, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2013	1	0

FIG. 1 — Lineage of K964766, 1977–2013Source: 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
*	K771603	Immochemistry System Summary page 1 …2 Classification Name Alpha-1-antitrypsin immunological test system. (21 CFR § 866.5130) 4.0 Predicate Device(s): IMMAGE System Beckman Alphas- Beckman Instruments, \| K771603 Inc. 5.0 Description: The IMMAGE Immunochemistry System AAT Reagent in conjunction with' Beckman Calibrator 2, is intended for u…	Beckman Instruments, Inc.	1977	—

Also cleared against K771603: 6 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K052819	Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…	Ortho-Clinical Diagnostics, Inc.	2005	3

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, K052819 (Ortho-Clinical Diagnostics, Inc., 2005) has gone furthest, with 3 descendants of its own.
6 other devices also cite its predicate K771603.

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?

The IMMAGE Immunochemistry System Alpha-1-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha-1-antitrypsin by rate nephelometry.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964766 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964766: Immage Immunochemistry System Alpha-1-Antitrypsin (Aat).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964766

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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