FDA顾问团对Osmetech公司尿道感染(Uti)检测设备
WASHINGTON (Reuters Health) -The Microbiology Devices Advisory Panel to the US Food and Drug Administration (FDA) expressed serious concern on Thursday about an Osmetech Plc device designed to diagnose urinary tract infections (UTIs).
Without taking a formal vote, the experts uniformly told attending FDA officials that they found the company's data inadequate, and also expressed some concern about the FDA's current standards for such devices. The FDA said it might clear the device despite the panel's reservations.
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The in vitro device, which Osmetech describes as an "electronic nose," is designed to sense gases that are released from microorganisms into the "headspace" above a urine sample. It is intended for use by clinical laboratory healthcare workers and, if approved, could significantly speed the time it takes to diagnose UTIs.
Osmetech's 510k application aimed to demonstrate that the device qualifies for approval because it is substantially equivalent to standard culture techniques, as well as to Uriscreen, a rapid urine analysis device already marketed by Diatech Diagnostics. Uriscreen is designed for use by consumers, but Osmetech said that the difference between the intended user populations has no effect on safety or efficacy.
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Osmetech is claiming substantial equivalence to Uriscreen based on the fact that both tests detect UTIs by measuring compounds produced by bacteria. The company acknowledged, however, that its test differs from Uriscreen in the specific compounds it measures and the technology it uses.
Osmetech's data showed that its device generated 115 false-positive results and 28 false-negative results from a batch of 1,028 samples. The study suggests the device would have only about a 44% positive predictive value for the presence of bacteria, but would be able to screen out non-infected urine about 96% of the time.
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The panel members took exception to the device's accuracy rate, although it was roughly equivalent to the performance of Uriscreen. "There may be approved products that are sadly inadequate in practice," cautioned Dr. L. Barth Reller, a clinical microbiologist at Duke University Medical Center who serves as a consultant to the committee. He urged the agency to set a higher bar.
The panel also raised a number of other issues, including an objection to the fact that the company was permitted to prescreen some samples in order to obtain a higher number of positive samples, although the intent of the test was to allow rapid identification of negative samples.
, 百拇医药
The FDA often follows the advice of its expert advisors, but the agency is not bound by their recommendations. Dr. Steven Gutman, who heads up the FDA division responsible for reviewing clinical laboratory devices, said the new test might well be cleared based on its equivalence to the Diatech device. "It will be legally challenging not to allow a better-characterized device on the market," he pointed out., 百拇医药
Without taking a formal vote, the experts uniformly told attending FDA officials that they found the company's data inadequate, and also expressed some concern about the FDA's current standards for such devices. The FDA said it might clear the device despite the panel's reservations.
, 百拇医药
The in vitro device, which Osmetech describes as an "electronic nose," is designed to sense gases that are released from microorganisms into the "headspace" above a urine sample. It is intended for use by clinical laboratory healthcare workers and, if approved, could significantly speed the time it takes to diagnose UTIs.
Osmetech's 510k application aimed to demonstrate that the device qualifies for approval because it is substantially equivalent to standard culture techniques, as well as to Uriscreen, a rapid urine analysis device already marketed by Diatech Diagnostics. Uriscreen is designed for use by consumers, but Osmetech said that the difference between the intended user populations has no effect on safety or efficacy.
, 百拇医药
Osmetech is claiming substantial equivalence to Uriscreen based on the fact that both tests detect UTIs by measuring compounds produced by bacteria. The company acknowledged, however, that its test differs from Uriscreen in the specific compounds it measures and the technology it uses.
Osmetech's data showed that its device generated 115 false-positive results and 28 false-negative results from a batch of 1,028 samples. The study suggests the device would have only about a 44% positive predictive value for the presence of bacteria, but would be able to screen out non-infected urine about 96% of the time.
, http://www.100md.com
The panel members took exception to the device's accuracy rate, although it was roughly equivalent to the performance of Uriscreen. "There may be approved products that are sadly inadequate in practice," cautioned Dr. L. Barth Reller, a clinical microbiologist at Duke University Medical Center who serves as a consultant to the committee. He urged the agency to set a higher bar.
The panel also raised a number of other issues, including an objection to the fact that the company was permitted to prescreen some samples in order to obtain a higher number of positive samples, although the intent of the test was to allow rapid identification of negative samples.
, 百拇医药
The FDA often follows the advice of its expert advisors, but the agency is not bound by their recommendations. Dr. Steven Gutman, who heads up the FDA division responsible for reviewing clinical laboratory devices, said the new test might well be cleared based on its equivalence to the Diatech device. "It will be legally challenging not to allow a better-characterized device on the market," he pointed out., 百拇医药