Cleared Traditional

K951320 - AURAFLEX TG-AB AND TPO-AB

K951320 is an FDA 510(k) clearance for AURAFLEX TG-AB AND 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 155-day FDA review.

K951320 · Organon Teknika Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
155d
Days
Class 2
Risk

K951320 is an FDA 510(k) clearance for the AURAFLEX TG-AB AND 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 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K951320

510(k) Number K951320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1995
Decision Date August 25, 1995
Days to Decision 155 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
51d slower than avg
Panel avg: 104d · This submission: 155d
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 K951320.
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006
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 TPO-AB
K952607 · Organon Teknika Corp. · Aug 1995
AUTOSTAT II ANTI-TPO
K943580 · Cogent Diagnotics , Ltd. · Apr 1995
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · Cogent Diagnotics , Ltd. · Sep 1992