510(k) Report

510(k) · Cleared

Cleared

Careside GGT

K020486510(k) TraditionalCleared Jul 1, 2002138-day reviewClass I21 CFR 862.1360

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

Careside, Inc. · JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase

Cleared on Jul 1, 2002 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 138-day review. Its family tree reaches back 1 generation to 1991.

Decided
Jul 1, 2002
Review
138 days
Class
Class I
Product code
JPZ
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 · 199119901992199419961998200020022004
K912844 · Kodak Ektachem Dtii System · Eastman Kodak Company · 19910
  1. Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
  2. This deviceK020486 Careside GGTCareside, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912844Kodak Ektachem Dtii SystemEastman Kodak Company1991—
0 (this device)K020486Careside GGTCareside, Inc.2002—
FIG. 1 — Lineage of K020486, 1991–2002Source: 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 JPZ? 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? (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
…n and Johnson's Vitros DTSC 60 (formerly Eastman Kodak's DTSC 60 11). Predicate Device 5 10K number: K9 12844/A Product Code: 75JPZ CARESIDE, Pnc.…
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 JPZ devices

JPZ Colorimetric Method, Gamma-Glutamyl Transpeptidase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPZ

FDA has decided no JPZ device since 2007.

Median 510(k) review, days · JPZ

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

Recalls per year · JPZ

No recall names JPZ since 2007.

Adverse event reports per year · JPZ

1in 2013

2011: 32013: 1
2007high 3 (2011) · low 0 (2007)2025

MAUDE reports naming product code JPZ, 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—03
20120—00
20130—01
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 the CARESIDE Analyzer to quantitatively measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Indications for use as stated in the FDA summary.

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
  • K020487Careside AltCareside, Inc. · 2002
  • K020488Careside TrglycerideCareside, Inc. · 2002
  • K993634Careside AnalyzerCareside, Inc. · 1999

More from Careside, Inc.

22 FDA decisions under this applicant name. See the company

  • K020484Careside LDHCareside, Inc. · 2002
  • K020487Careside AltCareside, Inc. · 2002
  • K020488Careside TrglycerideCareside, Inc. · 2002
  • K002792Careside CholinesteraseCareside, Inc. · 2000
  • K001462Careside HemoglobinCareside, Inc. · 2000

Recent decisions in JPZ

The JPZ category page

  • K961919Dma Gamma Glutamyltransferase (GGT) ProcedureData Medical Associates, Inc. · 1996
  • K923509Gamma-GTRandox Laboratories, Ltd. · 1992
  • K923091King Diagnostics Gamma GT ReagentKing Diagnostics, Inc. · 1992
  • K905618GGT ReagentAmresco, Inc. · 1991
  • K903304Roche Cobas Ready GGT ReagentRoche Diagnostic Systems, Inc. · 1990

https://510kreport.com/device/K020486 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020486: Careside GGT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020486

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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