510(k)

FDA clears DeepX Diagnostics digital dermatoscope to screen for suspected skin cancer lesions
By LabPulse.com staff writers
The device has conducted more than 180 thousand assessments in pharmacies and primary care clinics in Europe; DeepX is poised to enter the U.S. market.
June 6, 2023
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Leica Biosystems granted FDA clearance for Class II mismatch repair panel
By LabPulse.com staff writers
The Bond MMR Antibody Panel is available for clinical use on its automated Bond-III and Bond-Max immunohistochemistry instruments.
April 3, 2023
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FDA grants 510(k) clearance to DiaSorin for COVID-19 and flu A/B assay
By Leo O'Connor
The test detects and differentiates influenza A, influenza B, and SARS-CoV-2 viruses to help ensure physicians can recommend the most appropriate treatment for each patient.
March 20, 2023
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Becton Dickinson nabs FDA clearance for infectious vaginitis molecular test
By LabPulse.com staff writers
The BD vaginal panel running on the high-throughput BD Cor molecular diagnostic system tests for multiple common types of vaginitis using only a swab and one test.
March 16, 2023
Bd Vaginal Panel Cor System
FDA grants clearance to Abbott for first commercial laboratory test to detect traumatic brain injury
By LabPulse.com staff writers
The test runs on Abbott's Alinity i laboratory immunoassay instrument, providing a result in 18 minutes to help clinicians quickly assess concussion and triage patients, Abbott said. Negative results rule out the need for a CT scan.
March 7, 2023
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Copan Diagnostics receives second FDA clearance for semiautomated preanalytical processor
By LabPulse.com staff writers
With this second clearance, Colibri can prepare microbial suspensions for antibiotic susceptibility testing with the BioMérieux Vitek 2 system.
October 11, 2022
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OIG: FDA recommendations for future pandemics
By Leo O'Connor
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
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Week in Review: Multicancer early detection at ESMO, DiaSorin nabs FDA clearance for COVID-19 kit, IVD industry urges Congress to enact SALSA, and more
By Leo O'Connor
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September 14, 2022
FDA grants 510(k) clearance to DiaSorin for COVID-19 kit
By LabPulse.com staff writers
The kit, which runs on DiaSorin's Liaison MDX molecular diagnostics system, provides a sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens.
September 13, 2022
2021 08 23 18 25 2180 Covid Treatment Doctor 400
PixCell Medical, Insight Medical to distribute hematology analyzer
By LabPulse.com staff writers
PixCell said that its HemoScreen hematology analyzer delivers lab-grade diagnostics at the point of care without the need for external reagents or extensive training.
September 5, 2022
2021 01 12 23 44 3780 Blood Test Samples Lab 400
Cue Health requests FDA de novo clearance for at-home flu test
By LabPulse.com staff writers
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
2022 09 02 19 52 9683 Flu Season Ahead 400
NanoDx, SkyWater launch nano biosensor
By LabPulse.com staff writers
The companies said that as a result of the development, NanoDx is ready to prepare and submit the product for review by the U.S. Food and Drug Administration (FDA) with the aim of eventually commercializing a product based on the technology.
August 25, 2022
2021 06 30 22 19 4138 Digital Science Lab 400
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