Cleared Traditional

CARESIDE LDH (K020484) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020484 · Careside, Inc. · Chemistry device
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Jul 2002
Decision
140d
Days
Class 2
Risk

K020484 is an FDA 510(k) clearance for the CARESIDE LDH. Classified as Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (product code CFH), Class II - Special Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on July 3, 2002 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Careside, Inc. devices

Submission Details

510(k) Number K020484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2002
Decision Date July 03, 2002
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 88d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.