Although 443 different COVID-19 laboratory tests and collection products have received Emergency Use Authorization (EUA), Section 510(k) premarket clearance remains the pathway through which most new in vitro diagnostic tests and other medical devices reach the US market.¹ Accordingly, analyzing 510(k) clearances offers insight into the kinds of new lab tests that are emerging from the R&D pipeline. Here’s a quick briefing of 510(k) clearances issued in the past year.²

The 2022 Section 510(k) Year in Review

The FDA granted 510(k) clearance allowing for the marketing of 70 different lab tests or panels last year. That count doesn’t include related laboratory products like reagents, collection devices, results analysis software or testing platforms and instruments. Abbott and its various subsidiaries garnered the most clearances with 13, including three tests run on the firm’s Alinity m platform:

• The Alinity m STI Assay, a real-time PCR test to detect a range of sexually-transmitted infections (STIs);
• The Alinity i STAT High Sensitivity Troponin-I assay for diagnosis of myocardial infarction; and
• The Alinity m EBV quantitative test for Epstein-Barr Virus.

Abbott also got 510(k) clearance to market tests for albumin BCP2, creatinine, urea nitrogen2, Toxo IgG antibodies, β-amylase2, bilirubin, cholesterol, influenza, and strep.

Roche finished the year with 11 clearances. Eight of those products were Elecsys tests, including a new assay for early detection of Alzheimer’s disease, as well as immunoassays for testosterone 2 and IgG class antibodies to herpes simplex virus (HSV-1). The FDA also cleared three new tests for the Roche Cobas systems:

• Cobas SARS-CoV-2 Qualitative for use on the Cobas 6800/8800 Systems;
• Cobas HCV for hepatitis C;
• Cobas Influenza A/B & RSV nucleic acid for use on the Cobas Liat System;

Other companies that received multiple 510(k) clearances for new lab tests in 2022 included:

• BioFire (4 infectious disease tests);
• Becton Dickinson (3, including one test for STIs and two for bacterial pathogens);
• Cepheid (3 genetic Xpert tests run on the firm’s GeneXpert Dx System);
• Beckman Coulter (2 blood tests—one for total immunoglobulin E (IgE) and one for early detection of pregnancy); and
• Swiss Precision (2 early pregnancy tests).

By clinical application, it’s not surprising that tests for infectious diseases were the most common with 10 new products receiving 510(k) clearance, followed by pregnancy detection (6), STIs (5), and cardiovascular and cancer indications (4 apiece).

References

1. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas
2. https://www.fda.gov/medical-devices/510k-clearances/510k-devices-cleared-2022

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Of course, a new year has begun. Here are some of the key new FDA EUAs and clearances that were announced in January 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s)	Product
Micronoma	Breakthrough device designation for OncobiotaLUNG blood-based test categorizing lung nodules into high or low risk of malignancy
Scope Molecular Laboratory	EUA for SARS nCoV-2019 Multiplexed Assay RT PCR test for serial COVID-19 testing
Selux Diagnostics	510(k) clearance for Next Generation Phenotyping (NGP) System along with test panel to determine antimicrobial susceptibility of gram-positive bacteria
Cytovale	510(k) clearance for IntelliSep test for early detection of sepsis
DiaCarta	EUA for QuantiVirus MPXV Test Kit, monkeypox PCR test
Prenetics Global	Clearance for ACTOnco, a comprehensive genomic profiling test for solid tumors developed by ACT Genomics
Precision BioLogic	510(k) clearance for CRYOcheck Chromogenic Factor IX test for managing hemophilia B
Burning Rock	Breakthrough device clearance for OverC Multi-Cancer Detection Blood Test (MCDBT) for early detection of esophageal, liver, lung, ovarian, and pancreatic cancers in average risk patients ages 50 to 75
Datar Cancer Genetics	Breakthrough device clearance for TriNetra-Glio liquid biopsy test to diagnose brain tumors inaccessible to conventional biopsy
Becton Dickinson	EUA for Viasure Monkeypox virus Real-Time PCR Reagents assay for use on BD Max System
Visby Medical	EUA for RT-PCR assay to simultaneously detect and differentiate between SARS-CoV-2, influenza A, and influenza B viral RNA
Advin Biotech	EUA for Advin COVID-19 Antigen Test @Home for over-the-counter use
Oceanit Foundry	EUA for Assure-100 Rapid COVID-19 Home Test antigen assay for over-the-counter use
Foundation Medicine (Roche subsidiary)	Clearance for FoundationOne Liquid CDx test as companion diagnostic for Genentech's Rozlytrek (entrectinib)

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Manufacturer(s)	Product(s)
Geneseeq Technology	Shielding multi-cancer minimal residual disease detection (MRD) kit
Geneseeq Technology	MERCURY multi-cancer early detection (MCED) kit
MedMira	Vyra CoV2Flu Antigen Test combination assay for SARS-CoV-2 and influenza A and B
Roche	In Vitro Diagnostic Regulation (IVDR) certificate for qualitative immunohistochemical cancer biomarker assay that detects expression of PD-L1 for use as a companion diagnostic to assess likely response of cancer patients to Merck & Co.’s Keytruda, Roche’s Tecentriq, and other immune checkpoint inhibitors
Virax Biolabs	HPV test kit covering 18 human papillomavirus genotypes

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
Sysmex	Japan	Blood-based HISCL β-Amyloid 1-42 Assay Kit and HISCL β-Amyloid 1-40 Assay Kit for Alzheimer’s disease