FDA product code PSZ: Devices Detecting Influenza A, B, And C Virus Antigens

PSZ is the FDA product code for devices detecting influenza a, b, and c virus antigens. It is a Class II device, regulated under 21 CFR 866.3328 and reviewed by the Microbiology panel. FDA has cleared 73 510(k) submissions under PSZ, 6 in the last five years, from 28 different applicants. The average 510(k) review took 109 days (median 58); 230 days on average over the last three years. FDA has posted 5 recalls for PSZ devices, 1 initiated in the last five years.

Definition

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.

Classification

Field	Value
Device name	Devices Detecting Influenza A, B, And C Virus Antigens
Device class	Class II
Regulation	21 CFR 866.3328
Review panel	MI — Microbiology
Medical specialty	Microbiology
Premarket route	510(k)

510(k) clearances per year for PSZ

Year	Clearances	Avg. review days
2017	3	152
2018	5	50
2020	2	223
2023	2	118
2025	2	248
2026	2	212

Compare with all 510(k) review times · Search every PSZ clearance

Top PSZ applicants

Applicant	Clearances	Latest
Becton, Dickinson and Company	10	2015-06-10
Becton, Dickinson & CO	6	2016-02-25
Binax, Inc.	6	2009-08-12
Quidel Corp.	5	2011-10-24
Princeton BioMeditech Corp.	4	2018-09-18

23 more applicants have PSZ clearances. See the full list in Caduvo.

Most recent PSZ clearances

510(k)	Applicant	Device	Decision date	Review days
K254262	Ortho Clinical Diagnostics Inc. (QuidelOrtho)	Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA	2026-09-04	248
K252283	Nano-Ditech Corporation	Nano-Check Influenza A+B Test	2026-01-15	177
K250398	Innovita (Tangshan) Biological Technology Co., Ltd.	Innovita Flu A/B Antigen Rapid Test	2025-07-03	141
K241188	SEKISUI Diagnostics, LLC	Acucy® Influenza A&B Test with the Acucy® 2 System	2025-04-18	354
K232434	Bd	BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit	2023-12-05	116

Recalls for PSZ devices

5 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-01-05.

Year	Recalls
2017	1
2019	2
2020	1
2022	1

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

G0008 — Administration of influenza virus vaccine
Q2039 — Influenza virus vaccine, not otherwise specified
Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu)

Frequently asked questions

What is FDA product code PSZ?

PSZ is the FDA product code for devices detecting influenza a, b, and c virus antigens. It is a Class II device, regulated under 21 CFR 866.3328 and reviewed by the Microbiology panel.

What device class is PSZ?

Class II, regulation 21 CFR 866.3328. Typical premarket route: 510(k).

How long does a 510(k) take for product code PSZ?

Across 73 cleared submissions the average was 109 days from receipt to decision (median 58).

Which companies have the most PSZ clearances?

Becton, Dickinson and Company (10); Becton, Dickinson & CO (6); Binax, Inc. (6); Quidel Corp. (5); Princeton BioMeditech Corp. (4).

Have PSZ devices been recalled?

Yes: 5 product recalls across 4 recall events; the most recent began 2022-01-05.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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