510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K230349Substantially Equivalent

Lyra RSV+hMPV Assay

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

K230349 is the FDA 510(k) clearance record for Lyra RSV+hMPV Assay, a class II device, cleared for Quidel Corporation on under FDA product code OEM (Human Metapneumovirus (Hmpv) Rna Assay System). FDA's definition for product code OEM reads: "A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in...". FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K230349.

Clearance record

Decision date
Received
(29 days to decision)
Product code
OEM Human Metapneumovirus (Hmpv) Rna Assay System
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Quidel Corporation 10165 Mckellar Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEM

Trailing 12 months

FDA records hold no clearances under product code OEM in the trailing twelve months.

FDA records show no clearances under product code OEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260