510(k) Report

510(k) · Cleared

Cleared

Beckman Urine Protein Calibrator (Ucal)

K973928510(k) TraditionalCleared Dec 1, 199747-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 1, 1997 as substantially equivalent to K895883 (Beckman Instruments, Inc., 1989) and 3 other predicates after a 47-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided
Dec 1, 1997
Review
47 days
Class
Class II
Product code
JIX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K895883 (1989). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor2000: 1 descendant clearedK895883 · Beckman MA Microalbumin Reagent Kit · Beckman Instruments, Inc. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K895883 · Beckman MA Microalbumin Reagent Kit · Beckman Instruments, Inc. · 19890
  1. Root · 1 generation backK895883 Beckman MA Microalbumin Reagent KitBeckman Instruments, Inc. · 1989
  2. This deviceK973928 Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997
  3. Descendant · cites it directly · 0 of its ownK994325 Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc. · 2000

Most influential descendants

Showing 1 of 1 · See all
  • K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K895883Beckman MA Microalbumin Reagent KitBeckman Instruments, Inc.1989—
0 (this device)K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.1997—
+1K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K973928, 1989–2000Source: 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), 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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K895883Beckman MA Microalbumin Reagent Kit
Summary page 1
…oprietary Names Beckman Urine Protein Calibrator (UCAL) 3.2 Classification Name Calibrator (21 CFR § 862.1150) 4.0 Predicate Device(s): Device Beckman Urine Beckman K895883 (MA) Protein Calibrator | Protein Calibrator | Instruments, Inc. K926272 (TRU) K933078 (A1M) K951635 (IGU) 5.0 Description: Th…
Beckman Instruments, Inc.1989—
*K926272Beckman Transferrin Kit
Summary page 1
…on Name Calibrator (21 CFR § 862.1150) 4.0 Predicate Device(s): Device Beckman Urine Beckman K895883 (MA) Protein Calibrator | Protein Calibrator | Instruments, Inc. K926272 (TRU) K933078 (A1M) K951635 (IGU) 5.0 Description: The Beckman Urine Protein Calibrator is prepared from human urine to which…
Beckman Instruments, Inc.1993—
*K933078Beckman Alpha-1-Microglobulin (A1M) Reagent
Summary page 1
…rator (21 CFR § 862.1150) 4.0 Predicate Device(s): Device Beckman Urine Beckman K895883 (MA) Protein Calibrator | Protein Calibrator | Instruments, Inc. K926272 (TRU) K933078 (A1M) K951635 (IGU) 5.0 Description: The Beckman Urine Protein Calibrator is prepared from human urine to which albumin, trans…
Beckman Instruments, Inc.1994—
*K951635Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator…
Summary page 1
…862.1150) 4.0 Predicate Device(s): Device Beckman Urine Beckman K895883 (MA) Protein Calibrator | Protein Calibrator | Instruments, Inc. K926272 (TRU) K933078 (A1M) K951635 (IGU) 5.0 Description: The Beckman Urine Protein Calibrator is prepared from human urine to which albumin, transferrin, alpha-1…
Beckman Instruments, Inc.1995—

Also cleared against K895883: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc.20000

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 4 ancestors has a recall.
  • Of its descendants, K994325 (Beckman Coulter, Inc., 2000) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K895883.

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?

UCAL (Urine Protein Calibrator), when used in conjunction with Beckman microalbumin (MA), urine transferrin (TRU), alpha-1-microglobulin (A1M), and urine immunoglobulin G (IGU) 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 K895883

2 other devices cite the same predicate.

  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K965035Immage Immunochemistry System Microalbumin (MA) ReagentBeckman Instruments, Inc. · 1997

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/K973928 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973928: Beckman Urine Protein Calibrator (Ucal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973928

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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