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U.S. Department of Health and Human Services

Product Classification

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Device joint biological agent identification and diagnostic system (jbaids) tularemia detection kit
Regulation Description Francisella tularensis serological reagents.
Definition To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.
Physical State Kit contains 6 vacuum-sealed pouches of freeze-dried PCR reagents, containing 4 vials each, and six pouches containing one tube each of reconstitution buffer and reagent grade water. Designed to be used on the JBAIDS instrument (K051713).
Technical Method Real-time polymerase chain reaction (PCR)amplification and detection system.
Target Area Matrices: whole blood, sputum, colony and blood cultures.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOEH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3280
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible