Cleared Traditional

K941361 - MICROSOMAL EIA TEST KIT

K941361 is an FDA 510(k) clearance for MICROSOMAL 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 51-day FDA review.

K941361 · Immunoprobe, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
51d
Days
Class 2
Risk

K941361 is an FDA 510(k) clearance for the MICROSOMAL 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 May 11, 1994 after a review of 51 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 Immunoprobe, Inc. devices

FDA 510(k) Submission Details - K941361

510(k) Number K941361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date May 11, 1994
Days to Decision 51 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
54d faster than avg
Panel avg: 105d · This submission: 51d
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 K941361.
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
AUTOSTAT ANTI-THYROGLOBULIN
K923370 · Cogent Diagnotics , Ltd. · Sep 1992
AUTOSTAT ANTI-THYROID MICROSSOMAL
K923371 · Cogent Diagnotics , Ltd. · Sep 1992
SYNELISA TPO ANTIBODIES
K921787 · Elias U.S.A., Inc. · Jul 1992