Cleared Traditional

K770401 - LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (FDA 510(k) Clearance)

Class I Chemistry device.

K770401 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Apr 1977
Decision
55d
Days
Class 1
Risk

K770401 is an FDA 510(k) clearance for the LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE. Classified as Analyzer, Enzyme, For Clinical Use (product code JJI), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 26, 1977 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2500 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K770401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1977
Decision Date April 26, 1977
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJI Analyzer, Enzyme, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.