Cleared Traditional

TITAN GEL REP LDH-6 HV (K874145) - FDA 510(k) Clearance

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

K874145 · Helena Laboratories · Chemistry device
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Nov 1987
Decision
42d
Days
Class 2
Risk

K874145 is an FDA 510(k) clearance for the TITAN GEL REP LDH-6 HV. 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 November 24, 1987 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Helena Laboratories devices

Submission Details

510(k) Number K874145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date November 24, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K874145.
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K020467 · Helena Laboratories · Mar 2002
CARDIO REP LD
K940224 · Helena Laboratories · Aug 1994
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