FDA Watch

The Month in Global New Diagnostic Test Approvals

In addition to Emergency Use Authorization clearances for 15 COVID-19 tests, the FDA cleared a number of other non-coronavirus tests via its standard pathways. Here’s the rundown of key new approvals announced during March 2020.


Manufacturer(s) Product(s)
Life Technologies (Thermo Fisher Scientific) Clearance for Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer
Magnolia Medical Technologies Clearance for expanded Steripath Gen2 Initial Specimen Diversion Device line of blood contamination reduction products
Meridian Bioscience Clearance for Curian analyzer and Curian HpSA assay using immunofluorescent technology to detect Helicobacter pylori antigens in stool samples
Roche Clearance for CINtec Plus Cytology test to assess risk of cervical cancer in women with HPV infections
Roche Breakthrough device designation for Elecsys Galad score to diagnose early-stage hepatocellular carcinoma
Roche Clearance for Cobas Influenza A/B and RSV nucleic acid test running on firm’s Cobas Liat
Roche Clearance for Tina-quant C-Reactive Protein IV test for measuring C-reactive protein in serum and plasma on firm’s Cobas c systems
MFB Fertility Clearance for Proov at-home progesterone ovulation test
Abbott Clearances for i-Stat Chem8+ cartridge running on iStat 1 system for measuring:
*Glucose and creatinine
*Hematocrit (for determining total red cell volumes)
*Sodium, potassium, chloride and blood urea nitrogen
Siemens Healthineers Clearance for Advia Centaur BR assay to measure cancer antigen CA 27.29 using the Advia Centaur systems
BioMérieux Clearance for marketing Vitek 2 AST-GN Polymyxin B quantitative assay for antimicrobial susceptibility testing of Gram-negative bacilli
ARK Diagnostics Clearance for ARK Fentanyl II immunoassay to measure fentanyl in human urine at a cutoff concentration of 1.0 ng/mL on automated clinical chemistry lab analyzers
Ortho Clinical Diagnostics 510(k) clearance for Vitros BRAHMS procalcitonin assay to identify bacterial infections
Kurin Clearance for novel push-button needle


New CE Marks & Global Certifications

Notable European CE certifications announced during the period:


Manufacturer(s) Product(s)
Euroimmun (part of PerkinElmer) CE marking for Anti-SARS-CoV-2 ELISA tests for immunoglobulin classes A and G
Thermo Fisher Scientific CE marking for COVID-19 diagnostic test
DiaCarta CE marking for QuantiVirus SARS-CoV-2 test
AusDiagnostics CE marking for multiplex PCR assay for SARS-CoV2, influenza and respiratory syncytial virus (RSV)
Vision Medicals CE-IVD marking for SARS-CoV-2 Clinical Sequencing assay
3D Medicine Science & Technology CE marking for SARS-CoV-2 and Influenza A&B RT-qPCR detection kit
Qiagen CE marking for QiaStat-Dx Respiratory SARS-CoV-2 Panel to detect and differentiate SARS-CoV-2 and 21 other respiratory pathogens
Credo Diagnostics Biomedical CE marking for assay to detect SARS-CoV-2
Genematrix CE-IVD certification for Neoflex COVID-19 kit
CerTest BioTec CE marking for ViaSure SARS-CoV-2 Real Time PCR Detection Kit
Genomica CE marking for COVID-19 (SARS-CoV2) diagnostic kits
BGI CE-IVD marking Real-Time Fluorescent RT-PCR kit for detecting SARS-CoV-2
EliTech Group CE marking for GeneFinder COVID-19 RealAmp kit
Snibe Diagnostic CE marking for Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits
Co-Diagnostics CE-IVD marking for Logix Smart Coronavirus COVID-19
GenoScreen CE-IVD marking for Deeplex Myc-TB kit for tuberculosis antibiotic susceptibility and resistance
DxTerity Diagnostics CE marking for DxCollect at-home fingerstick blood collection device for RNA and DNA testing


Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Fosun Pharmaceutical China National Medical Products Administration emergency approval for SARS-CoV-2 detection kit
A*STAR and Tan Tock Seng Hospital Singapore Health Sciences Authority provisional approval for SARS-CoV-2 test

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