Cleared Traditional

K964693 - ELECSYS FSH ASSAY

K964693 is an FDA 510(k) clearance for ELECSYS FSH ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K964693 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
24d
Days
Class 1
Risk

K964693 is an FDA 510(k) clearance for the ELECSYS FSH ASSAY. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K964693

510(k) Number K964693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date December 16, 1996
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
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 - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 54
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K964693.
FSH MENOPAUSE PREDICTOR TEST
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K964720 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
DSL ACTIVE FSH IRMA
K962118 · Diagnostic Systems Laboratories, Inc. · Sep 1996
AMERLITE FSH ASSAY
K952285 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
K941221 · Dupont Medical Products · Jul 1994
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K935612 · Abbott Laboratories · Jun 1994