Dive Brief:
- Accelerate Diagnostics has pulled a Becton Dickinson-partnered sample prep instrument from the market after the Food and Drug Administration told it to obtain 510(k) clearance.
- The company listed the product as a Class I device exempt from 510(k) requirements. However, the FDA has now clarified that Accelerate Diagnostics must have 510(k) clearance to market and distribute the device.
- Analysts at Craig-Hallum said they are “somewhat surprised by the [FDA’s] decision as Arc does not directly lead to a patient result” and warned the action could delay the product by at least one year.
Dive Insight:
The FDA’s action affects the Accelerate Arc system and related blood culture system. The company calls the product a “novel application of inline centrifugation and automated sample prep techniques” that provides “a suspension of cleaned microbial cells for direct transfer” to a matrix-assisted laser desorption/ionization (MALDI) spotting plate.
While the device supports a process for identifying organisms from blood cultures, the Craig-Hallum analysts see it as “a cog in the lab’s workflow” that is “very similar to an individual lab centrifuge, chemistry or sample handling equipment.” Officials at the FDA see things differently.
“[The] FDA’s rationale was that MALDI mass spectrometers are 510(k) cleared instruments that are used to yield patient results, and since Arc falls within that workflow it also needs to be a 510(k) cleared instrument,” the analysts wrote in a note to investors.
After determining the regulatory status of Arc, the FDA told Accelerate Diagnostics to stop marketing the device in the U.S., remove or correct promotional information and revise its listing of the technology as a Class I device. Accelerate Diagnostics said it plans to promptly take all of the actions requested by the FDA.
The company has also sent a pre-submission package to the FDA to get feedback on a planned filing for 510(k) clearance. According to the analysts, Accelerate Diagnostics wants a meeting to get clarity from the FDA and requirements for studies. The analysts said they would be surprised if the device is back on the market before the third quarter of next year. The BD partnership is unaffected by the FDA’s action.
Shares in Accelerate Diagnostics fell 39% to below $1 on the day of the news.
