In separate actions, the FDA recently lowered the risk classifications for a laboratory test designed to diagnose diabetes mellitus and a genetic bone marrow test for patients with leukemia or myelodysplastic syndrome. In an Aug. 25 Federal Register notice (79 Fed. Reg. 50,549), the Food and Drug Administration (FDA) issued a final order to reclassify the COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay, a class III (highest risk) device into class II (special controls) to provide a reasonable assurance of the device’s safety and effectiveness. The order is effective Sept. 24. The FDA issued an order to the manufacturer classifying the device into class II on May 23, 2013. According to the final order, the device is assigned the generic name hemoglobin A1c test system. It is indicated to measure the percentage concentration of hemoglobin A1c in blood. The order said the measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus. Three potential risks associated with using the device are identified in the final order, which also includes steps to mitigate the risks. Roche Diagnostics Corp., based in Basel, […]
In separate actions, the FDA recently lowered the risk classifications for a laboratory test designed to diagnose diabetes mellitus and a genetic bone marrow test for patients with leukemia or myelodysplastic syndrome.
In an Aug. 25 Federal Register notice (79 Fed. Reg. 50,549), the Food and Drug Administration (FDA) issued a final order to reclassify the COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay, a class III (highest risk) device into class II (special controls) to provide a reasonable assurance of the device’s safety and effectiveness. The order is effective Sept. 24. The FDA issued an order to the manufacturer classifying the device into class II on May 23, 2013.
According to the final order, the device is assigned the generic name hemoglobin A1c test system. It is indicated to measure the percentage concentration of hemoglobin A1c in blood. The order said the measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.
Three potential risks associated with using the device are identified in the final order, which also includes steps to mitigate the risks.
Roche Diagnostics Corp., based in Basel, Switzerland, requested the reclassification. Its main U.S. office is in Indianapolis. Hoffmann-La Roche, also of Basel, owns Roche Diagnostics Corp.
Leukemia Test Reclassified
In a Sept. 3 Federal Register notice (79 Fed. Reg. 52,195), the FDA issued a final order to reclassify the early growth response 1 (EGR1) gene fluorescence in situ hybridization test system for specimen characterization, a class III (highest risk) device into class II (special controls) to provide a reasonable assurance of the device’s safety and effectiveness. The order is effective Oct. 3. The FDA issued an order to the manufacturer classifying the device into class II on July 29, 2013.
According to the final order, the device is intended to detect the EGR1 probe target on chromosome 5q in bone marrow specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The order said the assay results are intended to be interpreted only by a qualified pathologist or cytogeneticist.
Two potential risks (false negatives, false positives) associated with using the device are identified in the final order, which also includes steps to mitigate the risks.
The device reclassification request was made by Abbott Molecular Inc., based in Des Plaines, Ill., a subsidiary of Abbott Park, Ill.-based Abbott Laboratories.
Takeaway: The FDA has modified risk classifications for certain tests to reflect a lower risk.
