OEM · Class II · 21 CFR 866.3980

FDA Product Code OEM: Human Metapneumovirus (hmpv) Rna Assay System

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 Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infections.

Leading manufacturers include Quidel Corp., Gen-Probe Prodesse, Inc. and Prodesse, Inc..

6
Total
6
Cleared
80d
Avg days
2008
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Human Metapneumovirus (hmpv) Rna Assay System Devices (Product Code OEM)

6 devices
1–6 of 6
Cleared Mar 10, 2023
Lyra RSV+hMPV Assay
K230349
Quidel Corporation
Microbiology · 29d
Cleared Aug 14, 2013
PRO HMPV+ ASSAY
K132200
Gen-Probe Prodesse, Inc.
Microbiology · 29d
Cleared Mar 08, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K122189
Quidel Corp.
Microbiology · 227d
Cleared Jan 16, 2013
PRO HMPV+ ASSAY
K123838
Gen-Probe Prodesse, Inc.
Microbiology · 34d
Cleared Dec 15, 2011
QUIDEL MOLECULAR HMPV ASSAY
K112490
Quidel Corp.
Microbiology · 108d
Cleared Nov 07, 2008
PRO HMPV+ ASSAY
K082688
Prodesse, Inc.
Microbiology · 53d

About Product Code OEM - Regulatory Context

510(k) Submission Activity

6 total 510(k) submissions under product code OEM since 2008, with 6 receiving FDA clearance (average review time: 80 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.