YourBio Health gets FDA clearance for device to collect capillary whole blood

LabPulse.com staff writers
Apr 24, 2023
Lab Blood Samples Social

YourBio Health on Monday announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its TAP Micro Select device for collecting capillary whole blood samples.

The firm said that it has been developing Touch Activated Phlebotomy (TAP) technology that forms the basis of the device for more than 15 years with the aim of enabling painless and remote blood collection.

TAP Micro Select uses a bladeless microneedle array to enable virtually-painless collection of up to 500 μL of whole, capillary blood.

The device is suited for use in decentralized clinical trials and health and wellness testing by reducing barriers to blood collection, YourBio Health said.

Latest in 510(k)
Fda Button Social
FDA clears DeepX Diagnostics digital dermatoscope to screen for suspected skin cancer lesions
June 6, 2023
Digital Pathology Cytology Social
Leica Biosystems granted FDA clearance for Class II mismatch repair panel
April 3, 2023
Visit our Molecular Diagnostics Community
Sponsored
Visit our Molecular Diagnostics Community
April 5, 2024
Bd Vaginal Panel Cor System
Becton Dickinson nabs FDA clearance for infectious vaginitis molecular test
March 16, 2023
Related Stories
Lab Blood Woman2 Social
CE mark
Tasso nabs CE Mark for high-volume liquid blood collection device
2022 06 09 18 00 5852 Lab Blood Samples 400
FDA Clearance
Tasso nabs FDA clearance for blood collection lancet
2021 01 12 23 44 3780 Blood Test Samples Lab 400
Collaboration
Babson, BD expand blood sample collection partnership
Visit our Molecular Diagnostics Community
Sponsor Content
Visit our Molecular Diagnostics Community
More in 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
Fda Button Social
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
Digital Pathology Cytology Social
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
Fda Button Social
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
Football Player Concussion Social
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
Lab Virus Bacteria Research
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
2021 11 29 23 50 3003 Fda Button 20211129235739
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
Dear LabPulse.com member,
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
Page 1 of 17
Next Page