Cleared Traditional

K960370 - THYROGLOBULIN ANTIBODY ELISA

K960370 is an FDA 510(k) clearance for THYROGLOBULIN ANTIBODY ELISA, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K960370 · Immco Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
147d
Days
Class 2
Risk

K960370 is an FDA 510(k) clearance for the THYROGLOBULIN ANTIBODY ELISA. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on June 20, 1996 after a review of 147 days - within the typical 510(k) review window.

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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K960370

510(k) Number K960370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date June 20, 1996
Days to Decision 147 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 104d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZO Device Classification - Class 2, Special Controls

Product Code JZO System, Test, Thyroid 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 - JZO System, Test, Thyroid Autoantibody

All 61
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K960370.
THYROGLOBULIN ASSAY SYSTEM
K972190 · American Laboratory Products Co., Ltd. · Jul 1997
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K963695 · Diagnostic Products Corp. · Jan 1997
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · Immco Diagnostics, Inc. · Jun 1996
DIASTAT ANTI-THYROID PEROXIDASE KIT
K951487 · Shield Diagnostics, Ltd. · Jun 1995
DIASTAT ANTI-THYROGLOBULIN KIT
K952183 · Shield Diagnostics, Ltd. · Jun 1995
ORGENTEC ANTI-TPO ELISA
K952129 · American Laboratory Products Co., Ltd. · Jun 1995