Cleared Traditional

QUANTA LITE OMP PLUS ELISA (K081248) - FDA 510(k) Clearance

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

K081248 · Inova Diagnostics, Inc. · Immunology device
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Oct 2008
Decision
178d
Days
Class 2
Risk

K081248 is an FDA 510(k) clearance for the QUANTA LITE OMP PLUS ELISA. Classified as Antibodies, Outer-membrane Proteins (product code OKM), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 27, 2008 after a review of 178 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5785 - 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

Submission Details

510(k) Number K081248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2008
Decision Date October 27, 2008
Days to Decision 178 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
74d slower than avg
Panel avg: 104d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OKM Antibodies, Outer-membrane Proteins
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5785
Definition For The Detection Of Anti-outer Membrane Protein (anti-omp) Antibodies In Human Serum. To Aid In The Diagnosis Of Crohn's Disease.
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.