Cleared Traditional

K841580 - TSH RECEPTOR ANTIBODY KIT 125I TSH

K841580 is an FDA 510(k) clearance for TSH RECEPTOR ANTIBODY KIT 125I TSH, manufactured by Clinetics Corp.. The device is a Class 2 Chemistry device with product code JZO cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K841580 · Clinetics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
188d
Days
Class 2
Risk

K841580 is an FDA 510(k) clearance for the TSH RECEPTOR ANTIBODY KIT 125I TSH. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Clinetics Corp. (Tustin, US). The FDA issued a Cleared decision on October 22, 1984 after a review of 188 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5870 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinetics Corp. devices

FDA 510(k) Submission Details - K841580

510(k) Number K841580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date October 22, 1984
Days to Decision 188 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 88d · This submission: 188d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JZO System, Test, Thyroid Autoantibody

All 74
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K841580.
NOVA LITE TM THYROID
K904224 · Inova Diagnostics, Inc. · Oct 1990
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
K881933 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1988
SERA-TEK MICROSOMAL ANTIBODY TEST
K865053 · Miles Laboratories, Inc. · Feb 1987
CORDIA TG
K821489 · Cordis Corp. · Jun 1982
AGGLUTINOTEST-THYROGLOBULIN
K791458 · Volu Sol Medical Industries · Dec 1979
TEST, (IVDP) THYROID ANTIBODY
K760154 · Zeus Scientific, Inc. · Jul 1976