Cleared Traditional

CARDIO REP LD (K940224) - 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.

View all Helena Laboratories devices

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

All 27
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K940224.
SPIFE LD-12 KIT, MODEL 3338
K022455 · Helena Laboratories · Oct 2002
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467 · Helena Laboratories · Mar 2002
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
K921455 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1992
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
K905861 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1991
ROCHO ISOMUNE - LD
K894081 · Roche Diagnostic Systems, Inc. · Aug 1989
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
K892818 · Helena Laboratories · Jun 1989