Cleared Special

K152523 - JBAIDS Influenza A & B Detection Kit

K152523 is an FDA 510(k) clearance for JBAIDS Influenza A & B Detection Kit, manufactured by U.S Army Medical Materiel Development Activity. The device is a Class 2 Microbiology device with product code OCC cleared through the Special 510(k) pathway after a 28-day FDA review.

K152523 · U.S Army Medical Materiel Development Activity · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
28d
Days
Class 2
Risk

K152523 is an FDA 510(k) clearance for the JBAIDS Influenza A & B Detection Kit. Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by U.S Army Medical Materiel Development Activity (Fort Detrick, US). The FDA issued a Cleared decision on October 1, 2015 after a review of 28 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.

FDA 510(k) Submission Details - K152523

510(k) Number K152523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2015
Decision Date October 01, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

OCC Device Classification - Class 2, Special Controls

Product Code OCC Respiratory Virus Panel Nucleic Acid Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.
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.

Regulatory Peers - OCC Respiratory Virus Panel Nucleic Acid Assay System

All 79
Devices cleared under the same product code (OCC) and FDA review panel - the closest regulatory comparables to K152523.
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
K152386 · Luminex Molecular Diagnostics, Inc. · Dec 2015
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
K151226 · Cepheid · Dec 2015
ProFlu+ Assay
K153219 · Hologic, Inc. · Nov 2015
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
K152408 · Focus Diagnostics, Inc. · Sep 2015
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
K143653 · Nanosphere, Inc. · Sep 2015
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
K151464 · Alere Scarborough, Inc. · Jul 2015
K152523 · JBAIDS Influenza A & B Detection Kit
Download PDF FDA Summary U.S Army Medical Mate…