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Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Page Type
Product Code
Definition
A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Physical State
Gastrointestinal bacterial panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens.
Technical Method
A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Target Area
In vitro diagnostic device
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3990
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
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CFR § 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay

§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.

(a) Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

(b) Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).

[80 FR 67314, Nov. 2, 2015]

FDA Browser

by Innolitics

MI/
subpart-d—serological-reagents/
PCI
View Source

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Page Type
Product Code
Definition
A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Physical State
Gastrointestinal bacterial panel multiplex nucleic acid-based assay systems are devices that consist of reagents and instruments for the simultaneous detection and identification of multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens.
Technical Method
A qualitative in vitro diagnostic assay intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Target Area
In vitro diagnostic device
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3990
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
View Source

CFR § 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay

§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.

(a) Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

(b) Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).

[80 FR 67314, Nov. 2, 2015]