Cleared Traditional

K791373 - ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS

K791373 is an FDA 510(k) clearance for ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS, manufactured by Hoffmann-La Roche, Inc.. The device is a Class 2 Chemistry device with product code CFE cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K791373 · Hoffmann-La Roche, Inc. · Chemistry device
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Oct 1979
Decision
94d
Days
Class 2
Risk

K791373 is an FDA 510(k) clearance for the ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 94 days - within the typical 510(k) review window.

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 Hoffmann-La Roche, Inc. devices

FDA 510(k) Submission Details - K791373

510(k) Number K791373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1979
Decision Date October 26, 1979
Days to Decision 94 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
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFE Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K791373.
TITAN GEL LDH ISO-ENZYME CONTROL
K830872 · Helena Laboratories · Apr 1983
PARAGON ELECTROPHORESIS LACTATE REAG.KIT
K802628 · Beckman Instruments, Inc. · Dec 1980
TRANSPHOR TM LD LACTATE DEHYDROGENASE
K800568 · Corning Medical & Scientific · Apr 1980
LDH CLINI GEL KIT
K791827 · Clinical Sciences, Inc. · Oct 1979
ENZYME STABILIZING REAGENT (ESR)
K791656 · Electrophoresis Corp. of America · Sep 1979
LDH ISOENZYME REAGENT
K791657 · Electrophoresis Corp. of America · Sep 1979