510(k) Report

510(k) · Cleared

Cleared

Careside Globulin

K980055510(k) TraditionalCleared Jan 28, 199822-day reviewClass I21 CFR 862.1330

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

Exigent Diagnostics, Inc. · JGE Turbidimetric Method, Globulin

Cleared on Jan 28, 1998 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 22-day review. Its family tree reaches back 1 generation to 1991.

Decided
Jan 28, 1998
Review
22 days
Class
Class I
Product code
JGE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.

K912844 · Kodak Ektachem Dtii System · Eastman Kodak Company · 1991199019921994199619982000
K912844 · Kodak Ektachem Dtii System · Eastman Kodak Company · 19910
  1. Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
  2. This deviceK980055 Careside GlobulinExigent Diagnostics, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912844Kodak Ektachem Dtii SystemEastman Kodak Company1991—
0 (this device)K980055Careside GlobulinExigent Diagnostics, Inc.1998—
FIG. 1 — Lineage of K980055, 1991–1998Source: 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.

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  • 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? (1)

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
*K912844Kodak Ektachem Dtii System
Summary page 1
…Vitros TP and Albumin DT Slides (formerly Eastman Kodak, In¢.) and Johpson and Johmson's Vitros DT 60 (formerly Eastman Kodak’s DT 6O II). Predicate Device S10K number: K912844/A Product Code: 751IF PHONE NO. : 3183386783 Jan. 26 1998 B2:15PM P3 FROM : EXIGENT DIAGNOSTICS INC. PHONE NO.…
Eastman Kodak Company1991—

Also cleared against K912844: 28 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.
  • 28 other devices also cite its predicate K912844.

How does its category compare?

All JGE devices

JGE Turbidimetric Method, Globulin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGE

FDA has decided no JGE device since 2007.

Median 510(k) review, days · JGE

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

Recalls per year · JGE

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JGE

No MAUDE report names JGE since 2007.

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—10
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—

What is it indicated for?

For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to calculate globulin and albumin/globulin ratio from albumin and globulin results generated on the CareSide Analyzer by professionals to aid in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

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 K912844

28 other devices cite the same predicate.

  • K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+DT Slides: 153…Ortho-Clinical Diagnostics, Inc. · 20091 recall
  • K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131…Ortho-Clinical Diagnostics, Inc. · 2008
  • K020484Careside LDHCareside, Inc. · 2002
  • K020486Careside GGTCareside, Inc. · 2002
  • K020487Careside AltCareside, Inc. · 2002
  • K020488Careside TrglycerideCareside, Inc. · 2002

More from Exigent Diagnostics, Inc.

9 FDA decisions under this applicant name. See the company

  • K982118Careside AnalyzerExigent Diagnostics, Inc. · 1998
  • K981899Careside HDL-CholesterolExigent Diagnostics, Inc. · 1998
  • K981183Careside GlucoseExigent Diagnostics, Inc. · 1998
  • K980043Careside CreatinineExigent Diagnostics, Inc. · 1998
  • K980056Careside AnalyzerExigent Diagnostics, Inc. · 1998

https://510kreport.com/device/K980055 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980055: Careside Globulin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980055

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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