Cleared Traditional

K940224 - CARDIO REP LD (FDA 510(k) Clearance)

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

K940224 · Helena Laboratories · Chemistry device
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Aug 1994
Decision
211d
Days
Class 2
Risk

K940224 is an FDA 510(k) clearance for the CARDIO REP LD. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 211 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - 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.

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Submission Details

510(k) Number K940224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1994
Decision Date August 17, 1994
Days to Decision 211 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 88d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
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.