Cleared Traditional

K090755 - QUANTA LITE APS/PT IGG AND IGM ELISA

K090755 is an FDA 510(k) clearance for QUANTA LITE APS/PT IGG AND IGM ELISA, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code OPN cleared through the Traditional 510(k) pathway after a 318-day FDA review.

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

FDA 510(k) Submission Details - K090755

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 105d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OPN Device Classification - Class 2, Special Controls

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.