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U.S. Department of Health and Human Services

Product Classification

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Device prescription use blood glucose meter for near-patient testing
Regulation Description Glucose test system.
Definition Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
Physical State The device is comprised of glucose test strips and a meter that measures and displays the result.
Technical Method The user obtains a blood sample and applies it to a test strip that contains an enzyme that reacts with the glucose on the test strip. The test strip is inserted in the meter, which measures the amount of glucose in the blood sample.
Target Area Whole blood
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePZI
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1345
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible