510(k) Report

510(k) · Cleared

Cleared

Beckman Calibrator 2 (CAL2)

K973932510(k) TraditionalCleared Dec 15, 199761-day reviewClass II21 CFR 862.1150

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

Beckman Instruments, Inc. · JIX Calibrator, Multi-Analyte Mixture

Cleared on Dec 15, 1997 as substantially equivalent to K771603 (Beckman Instruments, Inc., 1977) and 4 other predicates after a 61-day review. Its family tree reaches back 1 generation to 1977. 4 later devices descend from it.

Decided
Dec 15, 1997
Review
61 days
Class
Class II
Product code
JIX
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K771603 (1977). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1979: 2 other ancestors1978: 1 other ancestor2005: 1 descendant cleared2006: 2 descendants cleared2013: 1 descendant clearedK771603 · Immochemistry System · Beckman Instruments, Inc. · 197719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K771603 · Immochemistry System · Beckman Instruments, Inc. · 19770
  1. Root · 1 generation backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
  2. This deviceK973932 Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc. · 1997
  3. Descendant · cites it directly · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
  4. Descendant · 2 generations on · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013
  6. 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K771603Immochemistry SystemBeckman Instruments, Inc.1977—
0 (this device)K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.1997—
+1K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance…Ortho-Clinical Diagnostics, Inc.2005—
+2K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator…Ortho-Clinical Diagnostics, Inc.20061
+3K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance…Ortho-Clinical Diagnostics, Inc.2013—
+2K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197920
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
201310
FIG. 1 — Lineage of K973932, 1977–2013Source: 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), 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 JIX? 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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K771603Immochemistry System
Summary page 1
…evice Name(s): 3.1 Proprietary Names Beckman Calibrator 2 (CAL2) 3.2 Classification Name Calibrator (21 CFR § 862.1150) Predicate Device(s): Beckman Beckman Beckman K771603 (AAT) Calibrator 2 Calibrator 2 Instruments, Inc. K780913 (PFB) K791339 (CER) K791340 (AMG) KS01977 (AT3) K940353 (B2M) Descrip…
Beckman Instruments, Inc.1977—
*K780913Additional Reagents Kits for Imm. System
Summary page 1
…(CAL2) 3.2 Classification Name Calibrator (21 CFR § 862.1150) Predicate Device(s): Beckman Beckman Beckman K771603 (AAT) Calibrator 2 Calibrator 2 Instruments, Inc. K780913 (PFB) K791339 (CER) K791340 (AMG) KS01977 (AT3) K940353 (B2M) Description: Beckman Calibrator 2 is derived from fresh frozen hu…
Beckman Instruments, Inc.1978—
*K791339Human Ceruloplasmin
Summary page 1
…assification Name Calibrator (21 CFR § 862.1150) Predicate Device(s): Beckman Beckman Beckman K771603 (AAT) Calibrator 2 Calibrator 2 Instruments, Inc. K780913 (PFB) K791339 (CER) K791340 (AMG) KS01977 (AT3) K940353 (B2M) Description: Beckman Calibrator 2 is derived from fresh frozen human plasma tha…
Beckman Instruments, Inc.1979—
*K791340Human ALPHA2 Macroglobulin
Summary page 1
…ame Calibrator (21 CFR § 862.1150) Predicate Device(s): Beckman Beckman Beckman K771603 (AAT) Calibrator 2 Calibrator 2 Instruments, Inc. K780913 (PFB) K791339 (CER) K791340 (AMG) KS01977 (AT3) K940353 (B2M) Description: Beckman Calibrator 2 is derived from fresh frozen human plasma that has been def…
Beckman Instruments, Inc.1979—
Kept off the family treeK501977Beckman Calibrator 2 (AT3)
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*K940353Beckman Beta-2-Microglobulin (B2M)
Summary page 1
…2.1150) Predicate Device(s): Beckman Beckman Beckman K771603 (AAT) Calibrator 2 Calibrator 2 Instruments, Inc. K780913 (PFB) K791339 (CER) K791340 (AMG) KS01977 (AT3) K940353 (B2M) Description: Beckman Calibrator 2 is derived from fresh frozen human plasma that has been defibrinated and processed. Ass…
Beckman Instruments, Inc.1994—

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.

NumberDeviceApplicantDecidedDescendants
K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20053

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?

  • None of the 5 ancestors has a 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 JIX devices

JIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIX

1in 2016

2007: 62008: 52009: 42010: 52011: 72012: 22013: 42014: 12015: 32016: 1
2007high 7 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIX

29in 2015

2007: 53 days median2008: 69 days median2009: 121 days median2010: 100 days median2011: 77 days median2013: 50 days median2015: 29 days median
2007high 121 (2009) · low 29 (2015)2026

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

Recalls per year · JIX

7in 2023

2007: 22008: 32009: 22010: 12011: 22012: 12014: 12016: 12017: 12018: 12019: 12020: 22023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2013)2026

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

Adverse event reports per year · JIX

18in 2025

2007: 1402008: 1732009: 392011: 92012: 32013: 242014: 352015: 42016: 62017: 172018: 162019: 122020: 222021: 92022: 112023: 132024: 152025: 18
2007high 173 (2008) · low 0 (2010)2025

MAUDE reports naming product code JIX, 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
20076532140
20085693173
20094121239
2010510010
201177729
20122—13
2013450024
20141—135
201532904
20161—16
20170—117
20180—116
20190—112
20200—222
20210—09
20220—011
20230—713
20240—015
20250—018
20260—1—

What is it indicated for?

CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha₁-antitrypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alpha₂-macroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.

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

Also cleared against K771603

6 other devices cite the same predicate.

  • K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4) Reagent, Synchron LX…Beckman Coulter, Inc. · 2003
  • K964842Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentBeckman Instruments, Inc. · 1997
  • K964766Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Beckman Instruments, Inc. · 1997
  • K965108Synchron LX Systems Immunoglobulin G/a/M ReagentBeckman Instruments, Inc. · 19972 recalls
  • K963868Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)Beckman Instruments, Inc. · 19972 recalls
  • K962294Immage Immunochemistry SystemBeckman Instruments, Inc. · 19962 recalls

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 JIX

The JIX category page

  • K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc. · 2016
  • K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015
  • K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL IIElitechgroup · 2015
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)Siemens Healthcare Diagnostics · 20152 recalls
  • K141388System CalibraterBeckman Coulter Ireland, Inc. · 2014

https://510kreport.com/device/K973932 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973932: Beckman Calibrator 2 (CAL2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973932

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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