Cleared Traditional

K904224 - NOVA LITE TM THYROID

K904224 is the FDA 510(k) clearance for NOVA LITE TM THYROID by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K904224 · Inova Diagnostics, Inc. · Immunology device
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Oct 1990
Decision
32d
Days
Class 2
Risk

K904224 is an FDA 510(k) clearance for the NOVA LITE TM THYROID. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 15, 1990 after a review of 32 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K904224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1990
Decision Date October 15, 1990
Days to Decision 32 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 104d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (JZO) and FDA review panel - the closest regulatory comparables to K904224.
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
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