Cleared Traditional

K915428 - KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT

K915428 is an FDA 510(k) clearance for KRONUS KALIBRE THYROGLOBULIN ANTIBODY E..., manufactured by Kronus. The device is a Class 2 Immunology device with product code JZO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K915428 · Kronus · Immunology device
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Mar 1992
Decision
119d
Days
Class 2
Risk

K915428 is an FDA 510(k) clearance for the KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Kronus (Dana Point, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 119 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 Kronus devices

FDA 510(k) Submission Details - K915428

510(k) Number K915428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1991
Decision Date March 30, 1992
Days to Decision 119 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 105d · This submission: 119d
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 74
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K915428.
SYNELISA TMAB
K915133 · Elias U.S.A., Inc. · Apr 1992
SYNELISA TGAB
K915134 · Elias U.S.A., Inc. · Apr 1992
SYNELISA TGAB/TMAB
K915135 · Elias U.S.A., Inc. · Apr 1992
IMMUNOWELL THYROGLOBULIN TEST
K905485 · General Biometrics, Inc. · Jan 1991
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