Cleared Traditional

K813572 - CENTRIA PROLACTIN TEST SET

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

K813572 · Ventrex Laboratories, Inc. · Chemistry device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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

Submission Details

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.

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 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

PROLACTIN (125) RADIOIMMUNAOASSAY

K803273 · Corning Medical & Scientific · Jan 1981

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-

K801020 · Travenol Laboratories, S.A. · Jul 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K813572

Ventrex Laboratories, Inc.

Mchenry, IL · US

Regulatory profile

82 submissions 82 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active