Cleared Traditional

K060564 - INFINITI SYSTEM (FDA 510(k) Clearance)

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

K060564 · AutoGenomics, Inc. · Pathology device
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Feb 2007
Decision
341d
Days
Class 2
Risk

K060564 is an FDA 510(k) clearance for the INFINITI SYSTEM. Classified as Test, Factor V Leiden Mutations, Genomic Dna Pcr (product code NPQ), Class II - Special Controls.

Submitted by AutoGenomics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 7, 2007 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.7280 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all AutoGenomics, Inc. devices

Submission Details

510(k) Number K060564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2006
Decision Date February 07, 2007
Days to Decision 341 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 77d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7280
Definition In Vitro Diagnostic Test To Detect The Factor V Leiden Mutation In Genomic Dna, As An Aid To Diagnosis In The Evaluation Of Patients With Suspected Thrombophilia.
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 Pathology devices follow this clearance model.