Cleared Traditional

IMMULITE PROLACTIN (K925846) - FDA 510(k) Clearance

Class I Chemistry device.

K925846 · Diagnostic Products Corp. · Chemistry device
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Mar 1993
Decision
107d
Days
Class 1
Risk

K925846 is an FDA 510(k) clearance for the IMMULITE PROLACTIN. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 5, 1993 after a review of 107 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K925846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1992
Decision Date March 05, 1993
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
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 79
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K925846.
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994
VISTA PROLACTIN ASSAY
K926386 · Syva Co. · Mar 1993
AFFINITY PROLACTIN TEST SYSTEM
K902698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · Baxter Healthcare Corp · Jun 1990
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578 · Diagnostic Products Corp. · Apr 1990