Cleared Traditional

QUANTA LITE APS/PT IGG AND IGM ELISA (K090755) - FDA 510(k) Clearance

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

K090755 · Inova Diagnostics, Inc. · Immunology device
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Feb 2010
Decision
318d
Days
Class 2
Risk

K090755 is an FDA 510(k) clearance for the QUANTA LITE APS/PT IGG AND IGM ELISA. Classified as Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex (product code OPN), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 1, 2010 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K090755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date February 01, 2010
Days to Decision 318 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
214d slower than avg
Panel avg: 104d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OPN Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
Definition For The Detection Of Autoantibodies To Phosphatidylserine (ps), Prothrombin (pt), Or Phosphatidylserine/prothrombin (ps/pt) Complex In Human Serum Or Plasma. To Aid In The Diagnosis Of Certain Autoimmune Thrombotic Disorders Such As Anti-phospholipid Syndrome And Those Secondary To Systemic Lupus Erythematosus Or Other Lupus-like Diseases
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.