Cleared Traditional

K880218 - BINAX PROLACTIN IRMA DIAGNOSTIC KIT

K880218 is an FDA 510(k) clearance for BINAX PROLACTIN IRMA DIAGNOSTIC KIT, manufactured by Binax, Inc.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K880218 · Binax, Inc. · Chemistry device
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Mar 1988
Decision
41d
Days
Class 1
Risk

K880218 is an FDA 510(k) clearance for the BINAX PROLACTIN IRMA DIAGNOSTIC KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on March 1, 1988 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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

FDA 510(k) Submission Details - K880218

510(k) Number K880218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1988
Decision Date March 01, 1988
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

CFT Device Classification - Class 1, General Controls

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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 - CFT Radioimmunoassay, Prolactin (lactogen)

All 65
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K880218.
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FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
K874621 · Cyberfluor, Inc. · Jan 1988
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355 · Medix Biotech, Inc. · Oct 1987
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K873400 · Serono Diagnostics, Inc. · Sep 1987