Pro Hmpv+ Assay
FDA 510(k) K123838 · Gen-Probe Prodesse, Inc.
510(k) numberK123838
Submission
- Device name
- Pro Hmpv+ Assay
- Applicant
- Gen-Probe Prodesse, Inc.
Waukesha, WI, US - Received
- December 13, 2012
- Decision date
- January 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OEM – Human Metapneumovirus (Hmpv) Rna Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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.
Other 510(k)s with product code OEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230349 | Lyra RSV+hMPV AssayOEM · Special | Quidel Corporation | 03/10/2023SE |
| K132200 | Pro Hmpv+ AssayOEM · Special | Gen-Probe Prodesse, Inc. | 08/14/2013SE |
| K122189 | Quidel Molecular RSV + HMPV AssayOEM · Traditional | Quidel Corp. | 03/08/2013SE |
| K112490 | Quidel Molecular HMPV AssayOEM · Traditional | Quidel Corp. | 12/15/2011SE |
| K082688 | Pro Hmpv+ AssayOEM · Traditional | Prodesse, Inc. | 11/07/2008SE |
More from Prodesse, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132238 | Proparaflu+ AssayOOU · Special | 08/26/2013SE |
| K132237 | Prodesse Profast+ AssayOQW · Special | 08/26/2013SE |
| K132200 | Pro Hmpv+ AssayOEM · Special | 08/14/2013SE |
| K132159 | Proadeno+ AssayOCC · Special | 08/14/2013SE |
| K132129 | Prodesse Proflu+ AssayOCC · Special | 08/09/2013SE |
| K123274 | Progastro SSCS AssayPCH · Traditional | 01/16/2013SE |
| K110968 | Proflu+ AssayOCC · Traditional | 06/27/2011SE |
| K102952 | Prodesse ProadenoOCC · Traditional | 12/03/2010SE |
| K101855 | Profast+ AssayOQW · Traditional | 07/23/2010SE |
Questions and answers
When was Pro Hmpv+ Assay cleared by the FDA?
Pro Hmpv+ Assay (K123838) received a 510(k) decision of Substantially Equivalent on January 16, 2013, 34 days after the submission was received.
What is the product code of K123838?
The FDA product code is OEM – Human Metapneumovirus (Hmpv) Rna Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.