Cleared Traditional

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698) - FDA 510(k) Clearance

Class I Chemistry device.

K944698 · Organon Teknika Corp. · Chemistry device
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Mar 1995
Decision
179d
Days
Class 1
Risk

K944698 is an FDA 510(k) clearance for the AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 179 days - an extended review 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: 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K944698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date March 21, 1995
Days to Decision 179 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 88d · This submission: 179d
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 23
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K944698.
ELECSYS PROLACTIN ASSAY
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AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994
COBAS CORE PROLACTIN EIA
K930305 · Roche Diagnostic Systems, Inc. · Aug 1993
VISTA PROLACTIN ASSAY
K926386 · Syva Co. · Mar 1993
IMMULITE PROLACTIN
K925846 · Diagnostic Products Corp. · Mar 1993
AMERLITE PROLACTIN-30 ASSAY
K922170 · Eastman Kodak Company · Sep 1992