Genzyme Osom Influenza a & B Test
FDA 510(k) K051244 · Genzyme Corp.
510(k) numberK051244
Submission
- Device name
- Genzyme Osom Influenza a & B Test
- Applicant
- Genzyme Corp.
Cambridge, MA, US - Received
- May 16, 2005
- Decision date
- February 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSZ – Devices Detecting Influenza A, B, And C Virus Antigens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3328
- Specialty
- Microbiology
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.
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| K252283 | Nano-Check Influenza A+B TestPSZ · Dual Track | Nano-Ditech Corporation | 01/15/2026SE |
| K250398 | Innovita Flu A/B Antigen Rapid TestPSZ · Traditional | Innovita (Tangshan) Biological Technology Co.… | 07/03/2025SE |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 SystemPSZ · Dual Track | SEKISUI Diagnostics, LLC | 04/18/2025SE |
| K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived KitPSZ · Traditional | Bd | 12/05/2023SE |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ · Traditional | Bd | 01/27/2023SE |
| K192719 | Osom Ultra Plus Flu A&B Test KitPSZ · Dual Track | SEKISUI Diagnostics, LLC | 04/03/2020SE |
| K191514 | CareStart Flu A&B PlusPSZ · Dual Track | Access Bio, Inc. | 02/18/2020SE |
| K182001 | Acucy Influenza A&B Test with the Acucy SystemPSZ · Dual Track | SEKISUI Diagnostics, LLC | 12/17/2018SE |
| K182157 | BioSign Flu A+BPSZ · Special | Princeton BioMeditech Corp. | 09/18/2018SE |
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| K102242 | Osom C. Difficile Toxin A/B TestLLH · Traditional | 12/21/2010SE |
| K092633 | Osom Influenza A&B Test , Model PN190PSZ · Special | 09/25/2009SE |
| K080662 | Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorNDY · Traditional | 05/15/2008SE |
| K063739 | Sepramesh, Model 5959-1214FTL · Traditional | 01/17/2007SE |
| K061508 | Osom Influenza A&B TestPSZ · Traditional | 06/12/2006SE |
| K053066 | Sepramesh Ip Bioresorbable Coating/Permanent MeshFTL · Traditional | 12/19/2005SE |
| K043035 | Sepragel ENT Bioresorbable Packing/StentKHJ · Traditional | 07/11/2005SE |
| K040241 | N-Geneous Wide Range CRP Reagent and Calibrator SetDCK · Traditional | 06/25/2004SE |
| K040868 | Sepramesh Ip Bioresorbable Barrier - Permanent MeshFTM · Traditional | 06/04/2004SE |
| K033864 | Genzyme Osom Trichomonas Rapid TestJWZ · Traditional | 04/02/2004SE |
Questions and answers
When was Genzyme Osom Influenza a & B Test cleared by the FDA?
Genzyme Osom Influenza a & B Test (K051244) received a 510(k) decision of Substantially Equivalent on February 21, 2006, 281 days after the submission was received.
What is the product code of K051244?
The FDA product code is PSZ – Devices Detecting Influenza A, B, And C Virus Antigens, a Class II (moderate risk) device regulated under 21 CFR 866.3328.