510(k) Report

510(k) · Cleared

Cleared

Careside LDH

K020484510(k) TraditionalCleared Jul 3, 2002140-day reviewClass II21 CFR 862.1440

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

Careside, Inc. · CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

Cleared on Jul 3, 2002 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 140-day review. Its family tree reaches back 1 generation to 1991.

Decided
Jul 3, 2002
Review
140 days
Class
Class II
Product code
CFH
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 deviceK020484 Careside LDHCareside, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912844Kodak Ektachem Dtii SystemEastman Kodak Company1991—
0 (this device)K020484Careside LDHCareside, Inc.2002—
FIG. 1 — Lineage of K020484, 1991–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 CFH? 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
Get a 510(k) Report

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
…Johnson’s Vitros DT 60 (formerly Eastman Kodak’s DT 60 II). Predicate Device 5 10K number: K912844/A Product Code: 75CFJ ~ CARESIDE, Inc.…
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 CFH devices

CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFH

FDA has decided no CFH device since 2007.

Median 510(k) review, days · CFH

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

Recalls per year · CFH

No recall names CFH since 2007.

Adverse event reports per year · CFH

No MAUDE report names CFH 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—00
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 the CARESIDE Analyzer to measure LDH activity from anti-coagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with certain liver diseases, heart diseases, and tumors of the lung, kidneys, and liver.

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
  • K020486Careside GGTCareside, 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

  • K020486Careside GGTCareside, Inc. · 2002
  • K020487Careside AltCareside, Inc. · 2002
  • K020488Careside TrglycerideCareside, Inc. · 2002
  • K002792Careside CholinesteraseCareside, Inc. · 2000
  • K001462Careside HemoglobinCareside, Inc. · 2000

Recent decisions in CFH

The CFH category page

  • K050790Spotchem II LDH TestArkray, Inc. · 2005
  • K895138Clinistat LDH Reagent TestHeraeus Kulzer, Inc. · 1989
  • K894578IQ LDHBd Becton Dickinson Vacutainer Systems Preanalytic · 1989
  • K880630Lactate Dehydrogenase (LDH-L)Tech-Co, Inc. · 1988
  • K860349Lactate Dehydrogenase (LDH) Reagent SetSterling Diagnostics, Inc. · 1986

https://510kreport.com/device/K020484 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020484: Careside LDH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020484

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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