The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The Alethia Pertussis assay utilizes loop
Alethia™ Pertussis - 480750

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Bordetella pertussis in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OZZ

Device Name: Bordetella Pertussis Dna Assay System

Device Class: 2

Physical State: Bordetella pertussis DNA detection assay systems are devices that consist of reagents and instruments for the detection of Bordetella pertussis DNA extracted from human respiratory specimens.

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.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to Bordetella pertussis DNA extracted from human respiratory specimens.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: in vitro diagnostic assay

Regulation Number: 866.3980

Third Party Flag: N

Medical Specialty: MI

Device Id: 00840733102226

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A