CLN - Regulatory Roundup

FDA Proposes 510(k) Exemption for Certain Flow Cytometry Instruments

Regulatory Roundup: May 2019

The Food and Drug Administration (FDA) has issued a proposed order to exempt certain class II flow cytometry instruments from 510(k) premarket notification requirements, subject to certain limitations and conditions. The proposed exemption applies only to cytometry instruments used for counting or characterizing cells. These instruments use well-understood and mature technology. The intent of this proposed order is to reduce the regulatory burden by providing a more streamlined and efficient process to bring these instruments to market, while also making flow cytometry instruments used to count or characterize cells more accessible to healthcare providers. To be considered exempt from premarket review, a flow cytometry instrument’s performance must be demonstrated with either fluorescent beads or detection materials coupled with fresh, fixed, stabilized cells that have been cleared, approved, or exempted from the premarket notification requirement.

FDA will continue to review the relevant functionality of cytometry devices when they are used clinically with an in vitro diagnostic device reagent or test kit that is subject to FDA premarket review. Additionally, cytometry instruments used for sorting or collecting cells, and instruments that are used as automated hematology analyzers or that perform automated differential cell counts, will still require premarket notification 510(k) clearance.

Anthrax Tests Should Go Through 510(k) Review Process, FDA Rules

In response to device manufacturers seeking advice on how the Food and Drug Administration (FDA) reviews tests for Bacillus anthracis—the bacteria that causes anthrax—FDA has issued a final rule classifying these tests into class II (moderate-risk) with special controls. This means the agency will continue to require a 510(k) premarket notification for these devices. These devices were previously unclassified and were considered part of a group of devices known as preamendment devices, because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act were signed into law. Because of this, prior to the final rule there had not been a definitive agency determination about the testing criteria required or the regulatory pathway to use for this type of device. FDA issued this rule to provide a clear and predictable review pathway for anthrax test developers and also to help these manufacturers address potential safety risks for lab workers using these devices.

FDA Grants De Novo Authorization to HemoSonics POC Coagulation Test

HemoSonics has received de novo marketing authorization from the Food and Drug Administration (FDA) for the Quantra QPlus system, which includes the fully automated Quantra Hemostasis Analyzer platform and QPlus cartridge. The Quantra QPlus system provides actionable information on coagulation status to clinicians at the point of care. It uses a fully sealed consumable cartridge and a patented ultrasound technology called sonic estimation of elasticity via resonance (SEER) sonorheometry to provide viscoelastic results in 15 minutes or less. SEER sonorheometry works by sending ultrasound pulses through a blood sample to induce resonance, causing the sample to oscillate. As the blood coagulates and its stiffness increases, the frequency of oscillation also increases. Clot times and stiffness values are then measured from the evolving shear modulus. The Quantra system also assesses platelet contribution to clot stiffness and the likelihood of there being residual heparin in a sample. Studies have demonstrated strong correlation between the Quantra and both standard laboratory tests and other viscoelastic hemostasis assays.

Ortho Gets CE Mark for Multi-test MicroSlide Technology

The CE mark has been granted to Ortho Clinical Diagnostics for the Vitros XT MicroSlide, a new technology that enables labs to use a single blood sample to run two tests simultaneously that are commonly ordered together. The postage-stamp-sized slides include the Vitros XT Urea-Crea slides for blood urea nitrogen and creatinine testing, Vitros XT Trig-Chol slides for triglycerides and cholesterol, and Vitros XT Glu-Ca slides for glucose and calcium. They come with spreading, masking, scavenger, and reagent layers already combined on a thin piece of film. This layered dry slide technology is what enables separate reaction domains. When plasma, serum, urine, or cerebrospinal fluid come in contact with these dry chemical layers, a spectral reaction then occurs. To measure this reaction, the Vitros XT MicroSlide uses Ortho’s optics technology, Digital Chemistry, which is designed to work with a reduced patient sample size of 3.8 µL. All slides run on the Vitros XT 7600 Integrated System. Ortho has also submitted the slides to the Food and Drug Admini­stration for premarket review.

FDA Clears GenePOC Strep A Test

GenePOC, a member of the Debiopharm Group, has received Food and Drug Administration clearance for the GenePOC Strep A assay. This qualitative assay detects group A streptococcus nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It provides results as early as 42 minutes for positive specimens and in approximately 70 minutes for negative specimens, without the need for culture confirmation, and could serve as an alternative to throat cultures and rapid antigen diagnostic tests for group A streptococcus. The GenePOC Strep A assay is designed for use with the revogene platform, an automated, standalone device that performs fluorescence-based real-time polymerase chain reaction testing on single-use proprietary microfluidic cartridges. The revogene has the ability to process eight clinical samples simultaneously and detect up to 12 genetic targets per sample.

FDA Starts Reorganization of the Center for Devices and Radiological Health

The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is beginning to reorganize in order to enhance communication among CDRH staff and enable more efficient activities across the total medical device product life cycle from premarket review to postmarket surveillance. Specifically, the reorganization will integrate CDRH’s premarket and postmarket program functions along product lines, creating a new structure that consolidates and integrates many of the current aspects of product review, quality, surveillance, and enforcement into a new, team-based approach. Implementation of the reorganization began on March 18 of this year, and FDA aims to complete it by September 30. While the reorganization is underway, individuals should continue to communicate with their current contacts in CDRH.