Cleared Traditional

K952607 - AURAFLEX TPO-AB

K952607 is an FDA 510(k) clearance for AURAFLEX TPO-AB, manufactured by Organon Teknika Corp.. The device is a Class 2 Immunology device with product code JNL cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K952607 · Organon Teknika Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
86d
Days
Class 2
Risk

K952607 is an FDA 510(k) clearance for the AURAFLEX TPO-AB. Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K952607

510(k) Number K952607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1995
Decision Date August 25, 1995
Days to Decision 86 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 104d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JNL Device Classification - Class 2, Special Controls

Product Code JNL Immunochemical, Thyroglobulin Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - JNL Immunochemical, Thyroglobulin Autoantibody

All 11
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K952607.
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · Hycor Biomedical, Inc. · Nov 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · Hycor Biomedical, Inc. · Nov 1996
AURAFLEX TG-AB AND TPO-AB
K951320 · Organon Teknika Corp. · Aug 1995
AUTOSTAT II ANTI-TPO
K943580 · Cogent Diagnotics , Ltd. · Apr 1995
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · Cogent Diagnotics , Ltd. · Sep 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371 · Cogent Diagnotics , Ltd. · Sep 1992