Cleared Traditional

K930485 - QUANTA LITE(TM) THYROID M ELISA

K930485 is the FDA 510(k) clearance for QUANTA LITE(TM) THYROID M ELISA by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code JZO) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K930485 · Inova Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
46d
Days
Class 2
Risk

K930485 is an FDA 510(k) clearance for the QUANTA LITE(TM) THYROID M ELISA. 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 March 16, 1993 after a review of 46 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 K930485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1993
Decision Date March 16, 1993
Days to Decision 46 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
58d faster than avg
Panel avg: 104d · This submission: 46d
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 K930485.
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K963695 · Diagnostic Products Corp. · Jan 1997
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · Immco Diagnostics, Inc. · Jun 1996
THYROGLOBULIN ANTIBODY ELISA
K960370 · Immco Diagnostics, Inc. · Jun 1996
ELIAS TGAB
K925922 · Elias U.S.A., Inc. · Jan 1993
ELIAS TMAB
K925923 · Elias U.S.A., Inc. · Jan 1993
SYNELISA TMAB
K915133 · Elias U.S.A., Inc. · Apr 1992