Cleared Traditional

K883305 - BINAX FSH IRMA TEST KIT

K883305 is the FDA 510(k) clearance for BINAX FSH IRMA TEST KIT by Binax, Inc.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K883305 · Binax, Inc. · Chemistry device
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Oct 1988
Decision
63d
Days
Class 1
Risk

K883305 is an FDA 510(k) clearance for the BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 63 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 Binax, Inc. devices

Submission Details

510(k) Number K883305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1988
Decision Date October 06, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
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 37
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K883305.
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · Abbott Laboratories · Feb 1989
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · Ciba Corning Diagnostics Corp. · Dec 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · Diagnostic Products Corp. · Nov 1988
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
K881142 · Amersham Corp. · Jul 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123 · Nichols Institute Diagnostics · Apr 1988
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
K873051 · American Dade · Oct 1987