Cleared Traditional

K864439 - BECKMAN EPSILON(TM) PROLACTIN TEST KIT

K864439 is an FDA 510(k) clearance for BECKMAN EPSILON(TM) PROLACTIN TEST KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K864439 · Beckman Instruments, Inc. · Chemistry device
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Jan 1987
Decision
70d
Days
Class 1
Risk

K864439 is an FDA 510(k) clearance for the BECKMAN EPSILON(TM) PROLACTIN TEST KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on January 21, 1987 after a review of 70 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K864439

510(k) Number K864439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date January 21, 1987
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 52
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K864439.
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
BINAX PROLACTIN IRMA DIAGNOSTIC KIT
K880218 · Binax, Inc. · Mar 1988
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355 · Medix Biotech, Inc. · Oct 1987
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860 · Hybritech, Inc. · Nov 1986
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240 · Abbott Laboratories · Sep 1986
DELFIA (TM) HUMAN PROLACTIN
K861542 · Lkb Instruments, Inc. · Jun 1986