Cleared Special

K183223 - Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K183223 · Diasorin Molecular, LLC · Microbiology device
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Dec 2018
Decision
29d
Days
Class 2
Risk

K183223 is an FDA 510(k) clearance for the Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack. Classified as Bordetella Pertussis Dna Assay System (product code OZZ), Class II - Special Controls.

Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on December 19, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diasorin Molecular, LLC devices

Submission Details

510(k) Number K183223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2018
Decision Date December 19, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OZZ Bordetella Pertussis Dna Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Qualitative In Vitro Diagnostic Assay Intended To Detect Bordetella Pertussis Dna Extracted From Human Respiratory Specimens. Detection Of Bordetella Pertussis Dna Aids In The Diagnosis Of Bordetella Pertussis Respiratory Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infection.
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 Microbiology devices follow this clearance model.