Cleared Traditional

K863678 - FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM

K863678 is an FDA 510(k) clearance for FOLLICLE STIMULATING HORMONE IMMUNOASSA..., manufactured by Nichols Institute Diagnostics. 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.

K863678 · Nichols Institute Diagnostics · Chemistry device
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Oct 1986
Decision
27d
Days
Class 1
Risk

K863678 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on October 16, 1986 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.

View all Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K863678

510(k) Number K863678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date October 16, 1986
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 68
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K863678.
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
K870520 · Hybritech, Inc. · Mar 1987
TERUMO SENSIBEAD EIA FSH KIT
K863928 · Terumo Medical Corp. · Dec 1986
UBI MAGIWEL(TM) FSH QUANTITATIVE
K864080 · United Biotech, Inc. · Nov 1986
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
K862813 · Serono Diagnostics, Inc. · Sep 1986
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
K862439 · Boots-Celltech Diagnostics, Inc. · Aug 1986
DELFIA (TM) HFSH KIT
K862043 · Lkb Instruments, Inc. · Jun 1986