Cleared Traditional

K883269 - PRL-QUANT

K883269 is the FDA 510(k) clearance for PRL-QUANT by Leeco Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K883269 · Leeco Diagnostics, Inc. · Chemistry device
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Sep 1988
Decision
41d
Days
Class 1
Risk

K883269 is an FDA 510(k) clearance for the PRL-QUANT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Leeco Diagnostics, Inc. (Southfield, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 41 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 K883269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1988
Decision Date September 13, 1988
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
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 K883269.
MILENIA(TM) PROLACTIN (MKPR1,5)
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AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
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PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
K873355 · Medix Biotech, Inc. · Oct 1987
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
K864439 · Beckman Instruments, Inc. · Jan 1987