510(k) Report

510(k) · Cleared

Cleared

Beckman Alpha-1-Microglobulin (A1M) Reagent

K933078510(k) TraditionalCleared Jan 11, 1994202-day reviewClass I21 CFR 866.5400

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

Beckman Instruments, Inc. · MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control

Cleared on Jan 11, 1994 after a 202-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 11, 1994
Review
202 days
Class
Class I
Product code
MGA
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2000: 1 descendant cleared1990200020102020
  1. This deviceK933078 Beckman Alpha-1-Microglobulin (A1M) ReagentBeckman Instruments, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK973928 Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK994325 Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc. · 2000
  4. Descendant · cites it directly · 0 of its ownK965033 Immage Immunochemistry System Alpha-1-Microglobulin (AI) ReagentBeckman Instruments, Inc. · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997 · cites it directly1descendant
  • K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc. · 2000 · 2 generations on0descendants
  • K965033Immage Immunochemistry System Alpha-1-Microglobulin (AI) ReagentBeckman Instruments, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933078Beckman Alpha-1-Microglobulin (A1M) ReagentBeckman Instruments, Inc.1994—
+1K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.1997—
+2K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc.2000—
+1K965033Immage Immunochemistry System Alpha-1-Microglobulin (AI) ReagentBeckman Instruments, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200010
FIG. 1 — Lineage of K933078, 1994–2000Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.19971
K965033Immage Immunochemistry System Alpha-1-Microglobulin (AI) ReagentBeckman Instruments, Inc.19970

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?

  • Of its descendants, K973928 (Beckman Instruments, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MGA devices

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

FDA decisions per year · MGA

FDA has decided no MGA device since 2007.

Median 510(k) review, days · MGA

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

Recalls per year · MGA

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MGA

No MAUDE report names MGA since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
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—

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in MGA

The MGA category page

  • K965033Immage Immunochemistry System Alpha-1-Microglobulin (AI) ReagentBeckman Instruments, Inc. · 1997

https://510kreport.com/device/K933078 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933078: Beckman Alpha-1-Microglobulin (A1M) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933078

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026