CareStart Flu A&B Plus

Q: What is the product code of K191514?

The FDA product code is PSZ – Devices Detecting Influenza A, B, And C Virus Antigens, a Class II (moderate risk) device regulated under 21 CFR 866.3328.

FDA 510(k) K191514 · Access Bio, Inc.

Substantially Equivalent

510(k) numberK191514

Submission

Device name: CareStart Flu A&B Plus
Applicant: Access Bio, Inc.
Somerset, NJ, US
Received: June 7, 2019
Decision date: February 18, 2020
Decision: Substantially Equivalent (SESE)
Type: Dual Track 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PSZ – Devices Detecting Influenza A, B, And C Virus Antigens
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3328
Specialty: Microbiology

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

Other 510(k)s with product code PSZ

510(k)	Device	Applicant	Decision
K254262	Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAPSZ · Dual Track	Ortho Clinical Diagnostics Inc. (QuidelOrtho)	09/04/2026SE
K252283	Nano-Check Influenza A+B TestPSZ · Dual Track	Nano-Ditech Corporation	01/15/2026SE
K250398	Innovita Flu A/B Antigen Rapid TestPSZ · Traditional	Innovita (Tangshan) Biological Technology Co.…	07/03/2025SE
K241188	Acucy® Influenza A&B Test with the Acucy® 2 SystemPSZ · Dual Track	SEKISUI Diagnostics, LLC	04/18/2025SE
K232434	BD Veritor System for Rapid Detection of Flu A+B CLIA Waived KitPSZ · Traditional	Bd	12/05/2023SE
K223016	BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ · Traditional	Bd	01/27/2023SE
K192719	Osom Ultra Plus Flu A&B Test KitPSZ · Dual Track	SEKISUI Diagnostics, LLC	04/03/2020SE
K182001	Acucy Influenza A&B Test with the Acucy SystemPSZ · Dual Track	SEKISUI Diagnostics, LLC	12/17/2018SE
K182157	BioSign Flu A+BPSZ · Special	Princeton BioMeditech Corp.	09/18/2018SE
K181853	Alere BinaxNOW Influenza A & B Card 2, Alere ReaderPSZ · Special	Alere Scarborough, Inc.	08/08/2018SE

More from Alere Scarborough, Inc.

510(k)	Device	Decision
K251604	CareSuperb COVID-19/Flu A&B Antigen Combo Home TestSCA · Traditional	08/22/2025SE
K241915	CareSuperb COVID-19 Antigen Home TestQYT · Traditional	01/29/2025SE

Questions and answers

When was CareStart Flu A&B Plus cleared by the FDA?

CareStart Flu A&B Plus (K191514) received a 510(k) decision of Substantially Equivalent on February 18, 2020, 256 days after the submission was received.

What is the product code of K191514?

The FDA product code is PSZ – Devices Detecting Influenza A, B, And C Virus Antigens, a Class II (moderate risk) device regulated under 21 CFR 866.3328.