Cleared Traditional

K943996 - DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (FDA 510(k) Clearance)

Class I Toxicology device.

K943996 · Dupont Medical Products · Toxicology device
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Optimized for regulatory review, auditing and printing
Oct 1994
Decision
65d
Days
Class 1
Risk

K943996 is an FDA 510(k) clearance for the DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Dupont Medical Products (N. Billerica, US). The FDA issued a Cleared decision on October 20, 1994 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1485 - the FDA toxicology device 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 Dupont Medical Products devices

Submission Details

510(k) Number K943996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date October 20, 1994
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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.