Cleared Traditional

K813572 - CENTRIA PROLACTIN TEST SET

K813572 is an FDA 510(k) clearance for CENTRIA PROLACTIN TEST SET, manufactured by Ventrex Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K813572 · Ventrex Laboratories, Inc. · Chemistry device
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Mar 1982
Decision
94d
Days
Class 1
Risk

K813572 is an FDA 510(k) clearance for the CENTRIA PROLACTIN TEST SET. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventrex Laboratories, Inc. devices

FDA 510(k) Submission Details - K813572

510(k) Number K813572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1981
Decision Date March 26, 1982
Days to Decision 94 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
6d slower than avg
Panel avg: 88d · This submission: 94d
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 K813572.
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · Abbott Laboratories · Oct 1982
TANDEM PROLACTIN KIT
K821545 · Hybritech, Inc. · Jun 1982
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT
K821305 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982
LEECO PRL-QUANT DIAGNOSTIC TEST KIT
K820039 · Leeco Diagnostics, Inc. · Jan 1982
MARRIA-HPRL RIA KIT
K812112 · Intl. Immunoassay Laboratories, Inc. · Aug 1981
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · Corning Medical & Scientific · Jan 1981