510(k) Report

510(k) · Cleared

Cleared

Human Alpha, Acid Glycoprotein

K791341510(k) TraditionalCleared Aug 16, 197931-day reviewClass I21 CFR 866.5420

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

Beckman Instruments, Inc. · DEX Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

Cleared on Aug 16, 1979 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 16, 1979
Review
31 days
Class
Class I
Product code
DEX
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2003: 1 descendant cleared19801990200020102020
  1. This deviceK791341 Human Alpha, Acid GlycoproteinBeckman Instruments, Inc. · 1979
  2. Descendant · cites it directly · 0 of its ownK032035 Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems…Beckman Coulter, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK964257 Immage Immunochemistry System Alpha-1-Acid Glycoprotein (Aag) ReagentBeckman Instruments, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…Beckman Coulter, Inc. · 2003 · cites it directly0descendants
  • K964257Immage Immunochemistry System Alpha-1-Acid Glycoprotein (Aag) ReagentBeckman Instruments, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K791341Human Alpha, Acid GlycoproteinBeckman Instruments, Inc.1979—
+1K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement…Beckman Coulter, Inc.2003—
+1K964257Immage Immunochemistry System Alpha-1-Acid Glycoprotein (Aag) ReagentBeckman Instruments, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200310
FIG. 1 — Lineage of K791341, 1979–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in DEX? 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?

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

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…Beckman Coulter, Inc.20030
K964257Immage Immunochemistry System Alpha-1-Acid Glycoprotein (Aag) 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, K032035 (Beckman Coulter, Inc., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DEX devices

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

FDA decisions per year · DEX

FDA has decided no DEX device since 2007.

Median 510(k) review, days · DEX

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

Recalls per year · DEX

No recall names DEX since 2007.

Adverse event reports per year · DEX

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code DEX, 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
20070—00
20080—00
20090—00
20100—00
20110—01
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 DEX

The DEX category page

  • K823765Anti Sera to Human OroscomucoidKent Laboratories, Inc. · 1982
  • K801909Lsa 290 Assay Reagents/NephelometricJ.T. Baker Chemical Co. · 1980
  • K781023Alpha-1-Acid Glycoprotein Serum, Anti-HUIcl Scientific · 1978
  • K760143Serum, Alpha-1-Glycoprotein Anti-HumanOxford Laboratories, Inc. · 1976

https://510kreport.com/device/K791341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K791341: Human Alpha, Acid Glycoprotein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K791341

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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