Cleared Traditional

K951362 - THYROGLOBULIN EIA TEST KIT

K951362 is an FDA 510(k) clearance for THYROGLOBULIN EIA TEST KIT, manufactured by Immunoprobe, Inc.. The device is a Class 2 Immunology device with product code JNL cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K951362 · Immunoprobe, Inc. · Immunology device
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Nov 1995
Decision
241d
Days
Class 2
Risk

K951362 is an FDA 510(k) clearance for the THYROGLOBULIN EIA TEST KIT. Classified as Immunochemical, Thyroglobulin Autoantibody (product code JNL), Class II - Special Controls.

Submitted by Immunoprobe, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on November 20, 1995 after a review of 241 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 Immunoprobe, Inc. devices

FDA 510(k) Submission Details - K951362

510(k) Number K951362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1995
Decision Date November 20, 1995
Days to Decision 241 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 105d · This submission: 241d
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 16
Devices cleared under the same product code (JNL) and FDA review panel - the closest regulatory comparables to K951362.
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · Monobind · Jul 1997
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
AURAFLEX TPO-AB
K952607 · Organon Teknika Corp. · Aug 1995
AUTOSTAT II ANTI-TPO
K943580 · Cogent Diagnotics , Ltd. · Apr 1995