Cleared Traditional

K820039 - LEECO PRL-QUANT DIAGNOSTIC TEST KIT

K820039 is the FDA 510(k) clearance for LEECO PRL-QUANT DIAGNOSTIC TEST KIT by Leeco Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K820039 · Leeco Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
15d
Days
Class 1
Risk

K820039 is an FDA 510(k) clearance for the LEECO PRL-QUANT DIAGNOSTIC TEST KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Leeco Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 15 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 Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K820039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1982
Decision Date January 22, 1982
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K820039.
TANDEM PROLACTIN KIT
K821545 · Hybritech, Inc. · Jun 1982
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT
K821305 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
CENTRIA PROLACTIN TEST SET
K813572 · Ventrex Laboratories, Inc. · Mar 1982
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · Corning Medical & Scientific · Jan 1981
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020 · Travenol Laboratories, S.A. · Jul 1980
PROLACTIN RIA KIT
K800740 · Amersham Corp. · Apr 1980