Cleared Traditional

K781125 - LDH ISOENZYME REAGENT

K781125 is the FDA 510(k) clearance for LDH ISOENZYME REAGENT by Electrophoresis Corp. of America. It is a Class 2 Chemistry device (product code CFE) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K781125 · Electrophoresis Corp. of America · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1978
Decision
38d
Days
Class 2
Risk

K781125 is an FDA 510(k) clearance for the LDH ISOENZYME REAGENT. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 38 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 Electrophoresis Corp. of America devices

Submission Details

510(k) Number K781125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 10, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 23
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K781125.
TRANSPHOR TM LD LACTATE DEHYDROGENASE
K800568 · Corning Medical & Scientific · Apr 1980
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373 · Hoffmann-La Roche, Inc. · Oct 1979
LDH CLINI GEL KIT
K791827 · Clinical Sciences, Inc. · Oct 1979
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080 · Corning Medical & Scientific · Feb 1978