Cleared Traditional

K781724 - NAD REDUCTION METHOD

K781724 is the FDA 510(k) clearance for NAD REDUCTION METHOD by Medical Analysis Systems, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K781724 · Medical Analysis Systems, Inc. · Chemistry device
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Nov 1978
Decision
23d
Days
Class 2
Risk

K781724 is an FDA 510(k) clearance for the NAD REDUCTION METHOD, LACTATE PYRIVATE. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Medical Analysis Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1978 after a review of 23 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K781724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1978
Decision Date November 03, 1978
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 K781724.
SERUM, LACTIC DEHYDROGENASE
K790020 · Fisher Scientific Co., LLC · Feb 1979
LDH REAGENT SYSTEM
K781765 · American Monitor Corp. · Nov 1978
LDH
K781775 · Gilford Diagnostics · Nov 1978
SINGLE VIAL LDH-L TRIS
K781538 · Boehringer Mannheim Corp. · Oct 1978
SINGLE VIAL LACTATE
K780563 · Boehringer Mannheim Corp. · Apr 1978
ULTRAZYME PLUS LDH
K780101 · Harleco · Feb 1978