Cleared Traditional

REAL-TIME PCR INTERNAL CONTROL 2B SET (K083430) - FDA 510(k) Clearance

Class I Microbiology device.

K083430 · Nanogen, Inc. · Microbiology device
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Jan 2009
Decision
57d
Days
Class 1
Risk

K083430 is an FDA 510(k) clearance for the REAL-TIME PCR INTERNAL CONTROL 2B SET. Classified as Internal Polymerase Chain Reaction Control, Not Assay Specific (product code OLD), Class I - General Controls.

Submitted by Nanogen, Inc. (San Diego, US). The FDA issued a Cleared decision on January 15, 2009 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nanogen, Inc. devices

Submission Details

510(k) Number K083430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2008
Decision Date January 15, 2009
Days to Decision 57 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 102d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLD Internal Polymerase Chain Reaction Control, Not Assay Specific
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
Definition Internal Control That Can Be Used In Real-time Polymerase Chain Reaction (pcr) Assays To Detect Systemic Variation That May Arise During The Extraction And Amplification Process Associated With Real-time Pcr Assays. It Is Not Intended To Monitor Other Real-time Pcr Processes.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.