Cleared Traditional

K801020 - GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-

K801020 is an FDA 510(k) clearance for GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-, manufactured by Travenol Laboratories, S.A.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K801020 · Travenol Laboratories, S.A. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1980
Decision
69d
Days
Class 1
Risk

K801020 is an FDA 510(k) clearance for the GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 69 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 Travenol Laboratories, S.A. devices

FDA 510(k) Submission Details - K801020

510(k) Number K801020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1980
Decision Date July 08, 1980
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
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 K801020.
MARRIA-HPRL RIA KIT
K812112 · Intl. Immunoassay Laboratories, Inc. · Aug 1981
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · Corning Medical & Scientific · Jan 1981
LACTI-QUANT
K801849 · Nuclear Medical Laboratories, Inc. · Sep 1980
PROLACTIN RIA KIT
K800740 · Amersham Corp. · Apr 1980
125 I PROLACTIN HORMONE RIA KIT
K792166 · Diagnostic Products Corp. · Nov 1979