Cleared Traditional

K790771 - LD-P REAGENT (LDH P-L REAGENT)

K790771 is the FDA 510(k) clearance for LD-P REAGENT (LDH P-L REAGENT) by Gilford Diagnostics. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K790771 · Gilford Diagnostics · Chemistry device
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May 1979
Decision
25d
Days
Class 2
Risk

K790771 is an FDA 510(k) clearance for the LD-P REAGENT (LDH P-L REAGENT). Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on May 15, 1979 after a review of 25 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 Gilford Diagnostics devices

Submission Details

510(k) Number K790771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1979
Decision Date May 15, 1979
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
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 83
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K790771.
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658 · Hoffmann-La Roche, Inc. · Jan 1980
SPIN CHEM REAGENT, DETERMINATION OF LDH-
K791081 · Smithkline Diagnostics, Inc. · Jul 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
K791085 · Smithkline Diagnostics, Inc. · Jul 1979
NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)
K790248 · Boehringer Laboratories · Apr 1979
SERUM, LACTIC DEHYDROGENASE
K790020 · Fisher Scientific Co., LLC · Feb 1979
LDH REAGENT SYSTEM
K781765 · American Monitor Corp. · Nov 1978