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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter HPart 862Subpart D → §862.3652


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D—Clinical Toxicology Test Systems


§862.3652   Organophosphate test system.

(a) Identification. An organophosphate test system is a device intended to measure organophosphate metabolites quantitatively in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The distribution of these devices is limited to laboratories with experienced personnel who are trained to measure and evaluate organophosphate exposure and guide public health response.

(2) Analytical testing must demonstrate the device has appropriate performance characteristics, including adequate precision and accuracy across the measuring range and near medical decision points.

[82 FR 48415, Oct. 18, 2017]

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