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U.S. Department of Health and Human Services

Product Classification

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Device capillary blood collection device for alternative site collection
Regulation Description Blood specimen collection device.
Definition A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
Physical State Sterile blood collection device which may or may not have micro-needles or other skin puncture mechanism integrated with the device. The device may include an anticoagulant or preservative.
Technical Method The blood is drawn into the collection device by puncture of capillaries located near the surface of the skin using micro-needles or similar small sharp objects.
Target Area Capillary whole blood for in vitro diagnostic testing
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePRJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1675
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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