Cleared Traditional

K063565 - QUANTA LITE SS-A 52 ELISA

K063565 is an FDA 510(k) clearance for QUANTA LITE SS-A 52 ELISA, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code OBE cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K063565 · Inova Diagnostics, Inc. · Immunology device
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Apr 2007
Decision
127d
Days
Class 2
Risk

K063565 is an FDA 510(k) clearance for the QUANTA LITE SS-A 52 ELISA. Classified as Anti-ss-a 52 Autoantibodies (product code OBE), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 4, 2007 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K063565

510(k) Number K063565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2006
Decision Date April 04, 2007
Days to Decision 127 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
22d slower than avg
Panel avg: 105d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBE Device Classification - Class 2, Special Controls

Product Code OBE Anti-ss-a 52 Autoantibodies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
Definition The Device Is Used For The Detection, In Human Serum Or Plasma, Of Autoantibodies To Ss-a 52. The Detection Of Ss-a 52 Autoantibodies May Aid In The Diagnosis Of Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis And Dermatomyositis.
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.