Cleared Traditional

K831742 - QUANTIMUNE HFSH RIA HUMAN FOLLICLE-

K831742 is the FDA 510(k) clearance for QUANTIMUNE HFSH RIA HUMAN FOLLICLE- by Bio-Rad. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831742 · Bio-Rad · Chemistry device
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Jul 1983
Decision
48d
Days
Class 1
Risk

K831742 is an FDA 510(k) clearance for the QUANTIMUNE HFSH RIA HUMAN FOLLICLE-. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 48 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 devices

Submission Details

510(k) Number K831742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1983
Decision Date July 18, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 44
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K831742.
LEE-BEAD BETA FSH (EIA)
K854837 · Leeco Diagnostics, Inc. · Jan 1986
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · American Dade · Dec 1985
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361 · Amersham Corp. · May 1985
IMMO PHASE FSH RADIOIMMUNOASSAY
K822227 · Corning Medical & Scientific · Aug 1982
AMERLEX ESH KIT
K820754 · Amersham Corp. · Apr 1982
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · Immunalysis Corporation · Jul 1981