Cleared Traditional

QUANTA LITE GP210 ELISA (K040885) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040885 · Inova Diagnostics, Inc. · Immunology device
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Jun 2004
Decision
81d
Days
Class 2
Risk

K040885 is an FDA 510(k) clearance for the QUANTA LITE GP210 ELISA. Classified as Autoantibodies, Nuclear Pore Glycoprotein Gp210 (product code NRI), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 25, 2004 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - 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 K040885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date June 25, 2004
Days to Decision 81 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
23d faster than avg
Panel avg: 104d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRI Autoantibodies, Nuclear Pore Glycoprotein Gp210
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
Definition The Device Is Used For The Detection, In Human Serum Or Plasma, Of Autoantibodies To Gp210 (nuclear Pore Glycoprotein Gp210) As An Aid In The Diagnosis Of Primary Biliary Cirrhosis.
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.