Gram-positive Bacteria And Their Resistance Markers

Device Code: 3553

Product Code(s): PAM

Definition: A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.

Device Classification Information

Device Type ID3553
Device NameGram-positive Bacteria And Their Resistance Markers
Physical StateBlood
Technical MethodMultiplexed DNA Hybridization Array
Target AreaSystemic
Regulation DescriptionMultiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3365 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePAM
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3553
DeviceGram-positive Bacteria And Their Resistance Markers
Product CodePAM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMultiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures.
CFR Regulation Number866.3365 [🔎]
Premarket Reviews
ManufacturerDecision
GREAT BASIN SCIENTIFIC, INC.
 
SUBSTANTIALLY EQUIVALENT
1
ICUBATE, INC.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
False Positive Result
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 2
Recalls
Manufacturer Recall Class Date Posted
1
BioFire Diagnostics, Inc.
II Jun-20-2014
2
BioFire Diagnostics, LLC
II Oct-30-2018
3
Great Basin Scientific, Inc.
II Jan-19-2017
4
Luminex Corporation
III Feb-11-2019
5
Luminex Corporation
II Nov-10-2018
6
Nanosphere, Inc.
II Sep-30-2014
7
Nanosphere, Inc.
II Sep-23-2014
TPLC Last Update: 2019-04-02 20:32:17

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