510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153012Substantially Equivalent

Sofia Influenza A+B FIA

Ortho-Clinical Diagnostics, Inc., San Diego, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153012 is the FDA 510(k) clearance record for Sofia Influenza A+B FIA, a class II device, cleared for Quidel Corporation on under FDA product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens). FDA's definition for product code PSZ reads: "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". FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K153012.

Clearance record

Decision date
Received
(90 days to decision)
Product code
PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Regulation
21 CFR 866.3328
Device class
Class II
Review panel
Microbiology
Applicant
Quidel Corporation 12544 High Bluff Dr., Suite 200, San Diego, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSZ

Trailing 12 months
2 clearances under product code PSZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260