510(k) Report

510(k) · Cleared

Cleared

Additional Reagents Kits for Imm. System

K780913510(k) TraditionalCleared Jun 22, 197817-day reviewClass II21 CFR 866.5040

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

Beckman Instruments, Inc. · DCF Albumin, Antigen, Antiserum, Control

Cleared on Jun 22, 1978 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Jun 22, 1978
Review
17 days
Class
Class II
Product code
DCF
Recalls
None
Predicates
0

13 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2000: 3 descendants cleared1996: 1 descendant cleared1997: 3 descendants cleared2004: 1 descendant cleared2003: 1 descendant cleared2005: 1 descendant cleared2006: 2 descendants cleared2013: 1 descendant cleared19801990200020102020
  1. This deviceK780913 Additional Reagents Kits for Imm. SystemBeckman Instruments, Inc. · 1978
  2. Descendant · cites it directly · 4 of its ownK973932 Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc. · 1997
  3. Descendant · 2 generations on · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
  4. Descendant · cites it directly · 2 of its ownK964842 Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4…Beckman Instruments, Inc. · 1997
  5. Descendant · 3 generations on · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
  6. Descendant · 4 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1996: 11997: 32000: 32003: 12004: 12005: 12006: 22013: 1
1996high 3 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 13 · See all
  • K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc. · 1997 · cites it directly4descendants
  • K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on3descendants
  • K964842Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentBeckman Instruments, Inc. · 1997 · cites it directly2descendants
  • K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc. · 2006 · 3 generations on1descendant
  • K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2013 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K780913Additional Reagents Kits for Imm. SystemBeckman Instruments, Inc.1978—
+1K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.1997—
+2K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance…Ortho-Clinical Diagnostics, Inc.2005—
+1K964842Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentBeckman Instruments, Inc.1997—
+3K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator…Ortho-Clinical Diagnostics, Inc.20061
+4K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance…Ortho-Clinical Diagnostics, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199730
200030
200310
200410
200510
200620
201310
FIG. 1 — Lineage of K780913, 1978–2013Source: 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.

Planning a device in DCF? 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? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.19974
K964842Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentBeckman Instruments, Inc.19972
K994293Dimension C4 Flex Reagent CartridgeDade Behring, Inc.20000
K994296Dimension C3 Flex Reagent CartridgeDade Behring, Inc.20000
K994294Dimension TRNF Flex Reagent CartridgeDade Behring, Inc.20000
K971958Synchron LX Systems Transferrin (TRFN) ReagentBeckman Instruments, Inc.19970
K962294Immage Immunochemistry SystemBeckman Instruments, Inc.19960

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, K973932 (Beckman Instruments, Inc., 1997) has gone furthest, with 4 descendants of its own.

How does its category compare?

All DCF devices

DCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCF

1in 2016

2009: 12010: 32011: 12012: 12013: 12014: 12015: 12016: 1
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCF

167in 2010

2010: 167 days median
2007high 167 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DCF

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · DCF

12in 2025

2008: 12017: 32018: 22019: 62020: 22021: 32022: 32023: 52024: 92025: 12
2007high 12 (2025) · low 0 (2007)2025

MAUDE reports naming product code DCF, 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—01
20091—00
2010316700
20111—00
20121—00
20131—00
20141—00
20151—00
20161—00
20170—03
20180—02
20190—16
20200—02
20210—03
20220—03
20230—05
20240—09
20250—012
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 DCF

The DCF category page

  • K153560Optilite Low Level Albumin KitThe Binding Site Group, Ltd. · 2016
  • K143118Human Microalbumin kit for use on SPAPLUSThe Binding Site Group, Ltd. · 2015
  • K142346Urine/CSF Albumin, Urine/CSF Albumin CalibratorBeckman Coulter Ireland, Inc. · 2014
  • K121045Human Albumin CSF KitThe Binding Site Group, Ltd. · 2013
  • K113072Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012

https://510kreport.com/device/K780913 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780913: Additional Reagents Kits for Imm. System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780913

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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