Cleared Traditional

K791827 - LDH CLINI GEL KIT

K791827 is the FDA 510(k) clearance for LDH CLINI GEL KIT by Clinical Sciences, Inc.. It is a Class 2 Chemistry device (product code CFE) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K791827 · Clinical Sciences, Inc. · Chemistry device
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Oct 1979
Decision
14d
Days
Class 2
Risk

K791827 is an FDA 510(k) clearance for the LDH CLINI GEL KIT. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 14 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 Clinical Sciences, Inc. devices

Submission Details

510(k) Number K791827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1979
Decision Date October 01, 1979
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 22
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K791827.
PARAGON ELECTROPHORESIS LACTATE REAG.KIT
K802628 · Beckman Instruments, Inc. · Dec 1980
TRANSPHOR TM LD LACTATE DEHYDROGENASE
K800568 · Corning Medical & Scientific · Apr 1980
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
K791373 · Hoffmann-La Roche, Inc. · Oct 1979
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080 · Corning Medical & Scientific · Feb 1978