Cleared Traditional

SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT (K942638) - FDA 510(k) Clearance

Class I Chemistry device.

K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
96d
Days
Class 1
Risk

K942638 is an FDA 510(k) clearance for the SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Orangeburg, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K942638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date September 07, 1994
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
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.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 18
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K942638.
ELECSYS LH ASSAY
K964694 · Boehringer Mannheim Corp. · Jan 1997
OPUS HLH
K962866 · Behring Diagnostics, Inc. · Aug 1996
COAT-A-COUNT LH IRMA
K951748 · Diagnostic Products Corp. · May 1995
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990