Cleared Traditional

K821489 - CORDIA TG

K821489 is an FDA 510(k) clearance for CORDIA TG, manufactured by Cordis Corp.. The device is a Class 2 Chemistry device with product code JZO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821489 · Cordis Corp. · Chemistry device
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Jun 1982
Decision
22d
Days
Class 2
Risk

K821489 is an FDA 510(k) clearance for the CORDIA TG. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Cordis Corp. (Walker, US). The FDA issued a Cleared decision on June 9, 1982 after a review of 22 days - a notably fast clearance 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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K821489

510(k) Number K821489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 09, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 61
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K821489.
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
AGGLUTINOTEST-THYROGLOBULIN
K791458 · Volu Sol Medical Industries · Dec 1979
TEST, (IVDP) THYROID ANTIBODY
K760154 · Zeus Scientific, Inc. · Jul 1976