Product Classification

• Device: blood collection device for cell-free nucleic acid
• Regulation Description: Blood collection device for cell-free nucleic acids.
• Definition: A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.
• Physical State: Direct-draw blood collection tube.
• Technical Method: Provides physical containment of blood specimen; integrity of blood specimen is stabilized by chemical reagents.
• Target Area: Human blood
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: QMA
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1676
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible