Cleared Traditional

K791085 - PLUS CHEM

K791085 is the FDA 510(k) clearance for PLUS CHEM by Smithkline Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K791085 · Smithkline Diagnostics, Inc. · Chemistry device
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Jul 1979
Decision
35d
Days
Class 2
Risk

K791085 is an FDA 510(k) clearance for the PLUS CHEM, DETERMINATION OF LD (LDH-P). Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on July 17, 1979 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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 Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K791085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date July 17, 1979
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
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 - CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

All 82
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K791085.
LDH (L-P) REAGENT
K800120 · Gilford Diagnostics · Feb 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658 · Hoffmann-La Roche, Inc. · Jan 1980
SPIN CHEM REAGENT, DETERMINATION OF LDH-
K791081 · Smithkline Diagnostics, Inc. · Jul 1979
LD-P REAGENT (LDH P-L REAGENT)
K790771 · Gilford Diagnostics · May 1979
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
K790248 · Boehringer Laboratories · Apr 1979
SERUM, LACTIC DEHYDROGENASE
K790020 · Fisher Scientific Co., LLC · Feb 1979