Cleared Traditional

K920345 - PROLACTIN ENZYME IMMUNOASSAY TEST KIT (...

K920345 is the FDA 510(k) clearance for PROLACTIN ENZYME IMMUNOASSAY TEST KIT (... by Medix Biotech, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K920345 · Medix Biotech, Inc. · Chemistry device
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Mar 1992
Decision
51d
Days
Class 1
Risk

K920345 is an FDA 510(k) clearance for the PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED). 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 March 18, 1992 after a review of 51 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 K920345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1992
Decision Date March 18, 1992
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 K920345.
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K913280 · Pb Diagnostic Systems, Inc. · Aug 1991
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
K904714 · Ciba Corning Diagnostics Corp. · Nov 1990