Cleared Traditional

K820048 - FSH RADIOIMMUNOASSAY TEST SYSTEM

K820048 is an FDA 510(k) clearance for FSH RADIOIMMUNOASSAY TEST SYSTEM, manufactured by Monobind. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K820048 · Monobind · Chemistry device
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Feb 1982
Decision
27d
Days
Class 1
Risk

K820048 is an FDA 510(k) clearance for the FSH RADIOIMMUNOASSAY TEST SYSTEM. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 27 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.

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FDA 510(k) Submission Details - K820048

510(k) Number K820048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1982
Decision Date February 04, 1982
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 69
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K820048.
GAMMADAB [125] FSH RADIOIMMUNAY KIT
K821611 · Clinical Assays, Inc. · Jun 1982
AMERLEX ESH KIT
K820754 · Amersham Corp. · Apr 1982
FOLLICLE STIMULATING HORMONE KIT
K820358 · Pcl-Ria, Inc. · Mar 1982
ANDRIA-FSH RIA TEST KIT
K813086 · Intl. Immunoassay Laboratories, Inc. · Dec 1981
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · Immunalysis Corporation · Jul 1981
FOLLICLE STIMULATING HORMONE ANTISERUM
K810852 · Pcl-Ria, Inc. · Apr 1981