510(k): Page 3

Abbott to develop new glucose-ketone monitoring system
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for the device, which will be the same size as the company's FreeStyle Libre 3 sensor, it said.
June 5, 2022
2021 09 27 23 55 5067 Diabetes Insulin Glucose Blood 400
Accelerate commercializes blood culture kit
By LabPulse.com staff writers
The move to commercialize the Accelerate Arc and BC system follows the completion of its IVD registration with the U.S. Food and Drug Administration (FDA).
May 15, 2022
2020 11 11 19 32 2939 Modern Lab Equipment 400
Qiagen's new HSV assay cleared in Europe
By LabPulse.com staff writers
With this latest regulatory clearance, Qiagen is now offering 15 CE-IVD assays for use on NeuMoDx 96 and 288 systems, in addition to the capability to process laboratory-developed tests (LDTs), the company said.
May 5, 2022
2019 05 02 23 38 2538 Check Mark 400
FDA clears COVID-19 test based on breath samples
By LabPulse.com staff writers
The InspectIR COVID-19 breathalyzer test provides results in less than three minutes, according to an FDA news release. It is the first COVID-19 breathalyzer test to receive FDA clearance, with others in development.
April 14, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
AMP calls for thorough evaluation of VALID Act
By LabPulse.com staff writers
The VALID Act would modify current oversight mechanisms for laboratory-developed testing (LDTs), and groups like AMP are expressing concerns with the current draft. The legislation removes the requirement for approval of LDTs by the U.S. Food and Drug Administration (FDA) in national emergencies. It also gives the FDA the ability to regulate in vitro clinical tests.
April 7, 2022
2022 04 08 18 37 5850 American Captial Building 400
Theralink lands payment code for advanced breast cancer assay
By LabPulse.com staff writers
Making use of both laser capture microdissection and reverse phase protein array technologies, the Theralink assay measures the tumor cell levels of activated proteins -- the primary targets of most U.S. Food and Drug Administration-approved therapies and biopharmaceutical investigational drugs, according to the company. As a result, oncologists can utilize this potentially predictive molecular tool when selecting appropriate therapies, Theralink said.
March 21, 2022
2021 05 21 20 55 6118 Breast Cancer 3 D 400
Foundation Medicine nabs FDA clearance for NSLC diagnostic
By LabPulse.com staff writers
The test received FDA clearance in February for identifying patients with microsatellite instability-high solid tumors who may benefit from pembrolizumab (Keytruda) treatment. FoundationOne CDx can now also be used as a companion diagnostic to identify patients with NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations.
March 17, 2022
2019 10 09 17 32 0093 Dna Cancer Cell 400
Diadem wins CE-IVD Mark for Alzheimer's prognostic blood test
By LabPulse.com staff writers
The prognostic blood test can predict likely progression to Alzheimer's disease up to six years in advance of symptoms, according to the company. AlzoSure previously received breakthrough device designation by the U.S. Food and Drug Administration (FDA) in January.
February 28, 2022
2022 03 02 00 55 3488 Woman Dementia Alzheimer 400
CMS will cover free over-the-counter COVID-19 tests
By Will Morton
No date has been established, yet CMS said by early spring Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free at local pharmacies and other participating facilities. The policy applies to tests cleared by the U.S. Food and Drug Administration (FDA).
February 2, 2022
2020 03 13 20 59 0533 White House 400
Siemens launches ELF test in the U.S. for NASH assessment
By LabPulse.com staff writers
The ELF test is ordered by a physician and generates a numeric score that has been proven to assess prognosis in patients with advanced fibrosis (F3 or F4) due to NASH. The test is now commercially available after receiving de novo marketing authorization from the U.S. Food and Drug Administration (FDA) in August 2021.
January 25, 2022
2019 08 20 22 16 4501 Liver Anatomy 400
Copan launches new colony selection software
By LabPulse.com staff writers
The software automatically detects and "tags" the best colonies to be picked for specimen workup, the company said. The software can interpret growth based on each laboratory's custom rules, presumptively identify colonial morphology, and preselect the best isolated colonies for workup, Copan added.
January 19, 2022
2022 01 20 22 11 6124 Copan Pheno Matrix Tag Plate 400
Agendia, Illumina partner on genomic testing for breast cancer
By LabPulse.com staff writers
Illumina and Agendia plan to develop new tests to enhance the care of breast cancer patients by using the Illumina MiSeqDx sequencing platform to expand the range of gene panels available for solid tumor analysis, Agendia said.
January 10, 2022
2020 01 16 22 39 3973 Dna Sequencing Genome 400
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