Cleared Traditional

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY (K940005) - FDA 510(k) Clearance

Class I Chemistry device.

K940005 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
59d
Days
Class 1
Risk

K940005 is an FDA 510(k) clearance for the ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on March 3, 1994 after a review of 59 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K940005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date March 03, 1994
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 87
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K940005.
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · Abbott Laboratories · Jun 1994
AFFINITY FSH TEST SYSTEM
K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
K895108 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · Abbott Laboratories · Feb 1989
HTSH RIABEAD DIAGNOSTIC KIT
K810381 · Abbott Laboratories · Feb 1981