Cleared Traditional

K944698 - AURAFLEX PROLACTIN 200 TEST PACK

K944698 is an FDA 510(k) clearance for AURAFLEX PROLACTIN 200 TEST PACK, manufactured by Organon Teknika Corp.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K944698 · Organon Teknika Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K944698

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.

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 56
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K944698.
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
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DSL ACTIVE PROLACTIN IRMA
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ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680 · Bio-Rad Laboratories, Inc. · Oct 1995
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K943811 · Biomerieux Vitek, Inc. · Nov 1994
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994
DUPONT ACA PLUS PROLACTIN (PROL) METHOD
K941220 · Dupont Medical Products · Jun 1994