Cleared Traditional

ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS (K791373) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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
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