Cleared Traditional

K873355 - MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. ...

K873355 is the FDA 510(k) clearance for MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. ... by Medix Biotech, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K873355 · Medix Biotech, Inc. · Chemistry device
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Oct 1987
Decision
50d
Days
Class 1
Risk

K873355 is an FDA 510(k) clearance for the MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 50 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K873355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1987
Decision Date October 09, 1987
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 49
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K873355.
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
K883878 · Amersham Corp. · Nov 1988
PRL-QUANT
K883269 · Leeco Diagnostics, Inc. · Sep 1988
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
K864439 · Beckman Instruments, Inc. · Jan 1987
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860 · Hybritech, Inc. · Nov 1986
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240 · Abbott Laboratories · Sep 1986