Aptima Trichomonas Vaginalis Assay - Panther
FDA 510(k) K122062 · Gen-Probe, Inc.
510(k) numberK122062
Submission
- Device name
- Aptima Trichomonas Vaginalis Assay - Panther
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- July 13, 2012
- Decision date
- January 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3860
- Specialty
- Immunology
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
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| K231316 | Aptima Trichomonas vaginalis AssayOUY · Traditional | Hologic, Inc. | 11/06/2023SE |
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| K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…OUY · Traditional | Cepheid | 08/29/2016SE |
| K161182 | Solana Trichomonas AssayOUY · Traditional | Quidel Corporation | 08/15/2016SE |
| K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…OUY · Traditional | Cepheid | 10/16/2015SE |
| K143329 | AmpliVue Trichomonas AssayOUY · Traditional | Quidel Corporation | 03/17/2015SE |
| K130268 | BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA AssayOUY · Traditional | Becton, Dickinson & CO | 08/23/2013SE |
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|---|---|---|
| K111409 | Aptima Combo 2 AssayLSL · Traditional | 05/03/2012SE |
| K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae MODEL#1091LSL · Traditional | 01/25/2007SE |
| K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199MKZ · Traditional | 01/22/2007SE |
| K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091LSL · Traditional | 11/07/2006SE |
| K061413 | Aptima CT Assay on the Tigris DTS SystemMKZ · Traditional | 10/13/2006SE |
| K061509 | Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196LSL · Traditional | 10/04/2006SE |
| K060652 | Tigris DTS Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/17/2006SE |
| K053446 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088MKZ · Traditional | 07/25/2006SE |
| K043224 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/09/2005SE |
| K043144 | Gen-Probe Aptima Assay for Neisseria GonorrhoeaeLSL · Traditional | 03/14/2005SE |
Questions and answers
When was Aptima Trichomonas Vaginalis Assay - Panther cleared by the FDA?
Aptima Trichomonas Vaginalis Assay - Panther (K122062) received a 510(k) decision of Substantially Equivalent on January 9, 2013, 180 days after the submission was received.
What is the product code of K122062?
The FDA product code is OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System, a Class II (moderate risk) device regulated under 21 CFR 866.3860.