Cleared Traditional

K920921 - ELISA TUBE PROLACTIN TEST KIT

K920921 is an FDA 510(k) clearance for ELISA TUBE PROLACTIN TEST KIT, manufactured by Bio Clinic Co.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K920921 · Bio Clinic Co. · Chemistry device
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Apr 1992
Decision
40d
Days
Class 1
Risk

K920921 is an FDA 510(k) clearance for the ELISA TUBE PROLACTIN TEST KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Bio Clinic Co. (St. Louis, US). The FDA issued a Cleared decision on April 8, 1992 after a review of 40 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 Bio Clinic Co. devices

FDA 510(k) Submission Details - K920921

510(k) Number K920921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1992
Decision Date April 08, 1992
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 66
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K920921.
VISTA PROLACTIN ASSAY
K926386 · Syva Co. · Mar 1993
IMMULITE PROLACTIN
K925846 · Diagnostic Products Corp. · Mar 1993
AMERLITE PROLACTIN-30 ASSAY
K922170 · Eastman Kodak Company · Sep 1992
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
K920345 · Medix Biotech, Inc. · Mar 1992
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135 · Amersham Corp. · Feb 1992
OPUS(R) PROLACTIN TEST SYSTEM
K913280 · Pb Diagnostic Systems, Inc. · Aug 1991