Cleared Traditional

K943996 - DUPONT ACA PLUS LUTEINIZING HORMONE (LH...

K943996 is an FDA 510(k) clearance for DUPONT ACA PLUS LUTEINIZING HORMONE (LH..., manufactured by Dupont Medical Products. The device is a Class 1 Toxicology device with product code CEP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K943996 · Dupont Medical Products · Toxicology device
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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

FDA 510(k) Submission Details - K943996

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

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.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 79
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K943996.
CONCEIVE OVULATION PREDICTOR
K953063 · Quidel Corp. · Aug 1995
COAT-A-COUNT LH IRMA
K951748 · Diagnostic Products Corp. · May 1995
CHEMILUMINESCENCE LH
K935319 · Nichols Institute Diagnostics · Apr 1995
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993