Cleared Traditional

K930486 - QUANTA LITE(TM) THYROID T ELISA

K930486 is an FDA 510(k) clearance for QUANTA LITE(TM) THYROID T ELISA, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DDC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K930486 · Inova Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
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Mar 1993
Decision
45d
Days
Class 2
Risk

K930486 is an FDA 510(k) clearance for the QUANTA LITE(TM) THYROID T ELISA. Classified as Thyroglobulin, Antigen, Antiserum, Control (product code DDC), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 15, 1993 after a review of 45 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

FDA 510(k) Submission Details - K930486

510(k) Number K930486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1993
Decision Date March 15, 1993
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 105d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDC Device Classification - Class 2, Special Controls

Product Code DDC Thyroglobulin, Antigen, Antiserum, Control
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 - DDC Thyroglobulin, Antigen, Antiserum, Control

All 10
Devices cleared under the same product code (DDC) and FDA review panel - the closest regulatory comparables to K930486.
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K991179 · Zeus Scientific, Inc. · Jun 1999
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835 · Monobind · Jul 1997
AUTOSTAT II ANTI-THYROGLOBULIN
K943625 · Cogent Diagnotics , Ltd. · Dec 1994
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · Miles Laboratories, Inc. · Feb 1987
THYMUNE-M
K780873 · Burroughs Wellcome Co. · Jun 1978
THYMUNE-T
K780874 · Burroughs Wellcome Co. · Jun 1978