Cleared Traditional

K802628 - PARAGON ELECTROPHORESIS LACTATE REAG.KIT

K802628 is an FDA 510(k) clearance for PARAGON ELECTROPHORESIS LACTATE REAG.KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code CFE cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K802628 · Beckman Instruments, Inc. · Chemistry device
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Dec 1980
Decision
49d
Days
Class 2
Risk

K802628 is an FDA 510(k) clearance for the PARAGON ELECTROPHORESIS LACTATE REAG.KIT. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1980 after a review of 49 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K802628

510(k) Number K802628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1980
Decision Date December 11, 1980
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 22
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K802628.
TITAN GEL ISO DOT LDH KIT
K842669 · Helena Laboratories · Nov 1984
CORNING LACTATE DEHYDROPHORETIC ASSAY
K841433 · Corning Medical & Scientific · May 1984
TITAN GEL LDH ISO-ENZYME CONTROL
K830872 · Helena Laboratories · Apr 1983
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