Cleared Traditional

K101185 - NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

K101185 is an FDA 510(k) clearance for NUCLEIC ACID DETECTION IMMUNOASSAY (NAD..., manufactured by Iris Molecular Diagnostics. The device is a Class 2 Immunology device with product code OWM cleared through the Traditional 510(k) pathway after a 510-day FDA review.

K101185 · Iris Molecular Diagnostics · Immunology device
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Sep 2011
Decision
510d
Days
Class 2
Risk

K101185 is an FDA 510(k) clearance for the NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY. Classified as Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers (product code OWM), Class II - Special Controls.

Submitted by Iris Molecular Diagnostics (Carlsbad, US). The FDA issued a Cleared decision on September 20, 2011 after a review of 510 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6040 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

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FDA 510(k) Submission Details - K101185

510(k) Number K101185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2010
Decision Date September 20, 2011
Days to Decision 510 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
405d slower than avg
Panel avg: 105d · This submission: 510d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWM Device Classification - Class 2, Special Controls

Product Code OWM Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6040
Definition Determines Rate Of Increase Of Total Prostate Specific Antigen At Ultrasensitive Concentration Levels (picogram/ml Serum), And Identifies Those Patients Following Prostatectomies Which Are At Reduced Risk For Recurrence Of Prostate Cancer.
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.