FDA Clears Sekisui’s OSOM COVID-19/Flu Combo Test

SEKISUI Diagnostics says it has won FDA 510(k) clearance for the OSOM COVID-19/Flu A&B Combo Test and is launching the product now — a lateral-flow antigen panel that reads SARS-CoV-2 and influenza A/B from a single anterior nasal swab at the point of care. The San Diego-based company's 27 October 2026 announcement frames the clearance around timing as much as performance: it positions the new test as a fully cleared alternative to its existing combo test, which has sold under an FDA Emergency Use Authorization since 2024, ahead of the planned end of the COVID-19 EUA pathway this season.

A cleared product where an authorized one used to be

The regulatory shift matters more than it might look. An Emergency Use Authorization is a pandemic-era mechanism FDA can revoke or let lapse once the underlying public health emergency determination ends; a 510(k) clearance is a standing marketing authorization that does not depend on an active emergency declaration. SEKISUI's own announcement makes that distinction the center of its pitch: Erica Blight, the company's VP of Strategy, is quoted saying the clearance gives customers “a 510(k) cleared alternative” as the COVID-19 EUA pathway is planned to end this season. For point-of-care sites — urgent care clinics, pharmacies, physician offices — that is the practical question a combo-test purchase now has to answer: will this product still be legally marketable once the emergency authorization it might otherwise have relied on goes away.

What the test does

The OSOM COVID-19/Flu A&B Combo Test is a single-swab, single-run lateral-flow antigen test. It detects and differentiates three targets — SARS-CoV-2 nucleocapsid antigen, influenza A nucleoprotein antigen and influenza B nucleoprotein antigen — from one anterior nasal swab, intended to let a point-of-care site triage a respiratory-symptom patient into one of several categories without ordering separate tests or sending a sample to a central lab. Its CLIA-waived status means it can be run in settings holding only a CLIA Certificate of Waiver, the least burdensome laboratory-oversight category, which is what makes a product like this viable for urgent care and pharmacy point-of-care use rather than requiring a moderate- or high-complexity laboratory. Each kit ships with two additional patient tests, branded “QC Inside,” that sites can run against known positive or negative material at no extra cost, rather than having to purchase separate external control kits.

“[This clearance gives] our customers a 510(k) cleared alternative” ahead of the planned termination of the COVID-19 Emergency Use Authorization pathway this season. Erica Blight, VP of Strategy, SEKISUI Diagnostics

What RA/QA teams should take from it

• EUA-to-clearance transitions are accelerating. IVD manufacturers still selling a respiratory combo test under an EUA should treat this as a live reminder to confirm their own product's authorization status against FDA's current EUA-termination timeline, not assume an emergency authorization persists indefinitely.
• CLIA-waiver status is doing real commercial work here. A clearance alone does not open point-of-care and retail-pharmacy channels; the CLIA waiver is what does, and it is a separate FDA determination worth tracking independently in a competitor's labeling.
• The 510(k) number is not yet public. SEKISUI's own release does not state it, and this newsroom could not independently verify one against FDA's database this run — a gap worth watching for sponsors benchmarking submission timelines against comparable combo-test clearances.
• Built-in QC is a labeling and workflow detail, not a footnote. Bundling control material directly in the kit is a design choice other IVD sponsors targeting point-of-care settings may want to track as a competitive and usability benchmark.

Frequently asked questions

What did FDA clear for SEKISUI Diagnostics?

The OSOM COVID-19/Flu A&B Combo Test, a lateral-flow antigen test that detects and differentiates SARS-CoV-2 nucleocapsid antigen and influenza A and B nucleoprotein antigens from a single anterior nasal swab. SEKISUI announced the FDA 510(k) clearance and commercial launch on 27 October 2026; the test is CLIA-waived for point-of-care use in professional healthcare settings.

How is this different from SEKISUI's existing combo test?

SEKISUI has sold a COVID-19/flu combo antigen test, the OSOM Flu SARS-CoV-2 Combo Test, under FDA Emergency Use Authorization (EUA230045) since 2024. The new OSOM COVID-19/Flu A&B Combo Test carries a full 510(k) clearance rather than an EUA. The company's VP of Strategy, Erica Blight, says the clearance gives customers a 510(k)-cleared alternative ahead of the planned termination of the COVID-19 EUA pathway this season.

What comes in the kit?

Each kit includes two extra patient tests, branded "QC Inside," for free external quality control runs — intended to let point-of-care sites verify test performance without buying separate control material.

Is this the test's FDA 510(k) number public yet?

SEKISUI's own announcement does not state the specific 510(k) number, and this newsroom could not independently confirm it against FDA's public database this run. This article does not print an unverified figure.