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# Class 2 Designation for Organophosphate Test System
- URL: https://www.fdaweb.com/class-2-designation-for-organophosphate-test-system/
- Published: 2017-10-18T12:00:00.000Z
- Updated: 2026-09-14T22:56:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139899

*Federal Register* notice: FDA has classified the organophosphate test system into Class 2 (special controls). The agency action is the result of a 2013 de novo petition from the Centers for Disease Control and Prevention for its Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS. The agency has named the generic type of device organophosphate test system, and it is identified as 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 are intended to aid in the confirmation and investigation of organophosphate exposure. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-18/pdf/2017-22590.pdf?ref=fdaweb.com).