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U.S. Department of Health and Human Services

Product Classification
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Device groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
Regulation Description Streptococcus spp. nucleic acid-based assay.
Definition An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
Physical State May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification
Technical Method Uses nucleic acid amplification technology to detect Groups A, C and G Sreptococci
Target Area Throat swab specimen
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePGX
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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