Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays
FDA 510(k) K032194 · Gen-Probe, Inc.
510(k) numberK032194
Submission
- Device name
- Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- July 18, 2003
- Decision date
- December 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LSL – Dna-Reagents, Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code LSL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae AssayLSL · Traditional | Hologic, Inc. | 01/26/2024SE |
| K180681 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic, Inc. | 06/13/2018SE |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systemsLSL · Traditional | Roche Molecular Systems, Inc. | 03/21/2018SE |
| K173840 | Xpert CT/NGLSL · Traditional | Cepheid | 03/16/2018SE |
| K163184 | cobas® CT/NG v2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 02/09/2017SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 05/20/2014SE |
| K140354 | Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time Ct/NgLSL · Traditional | Abbott Molecular, Inc. | 05/09/2014SE |
| K140887 | Cobas Ct/Ng V2.0 TestLSL · Special | Roche Molecular Systems, Inc. | 05/05/2014SE |
| K132270 | Cobas Ct/Ng V2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 12/02/2013SE |
| K132251 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic / Gen-Probe Incorporated | 10/17/2013SE |
More from Hologic / Gen-Probe Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K122062 | Aptima Trichomonas Vaginalis Assay - PantherOUY · Traditional | 01/09/2013SE |
| 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 |
Questions and answers
When was Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays cleared by the FDA?
Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays (K032194) received a 510(k) decision of Substantially Equivalent on December 24, 2003, 159 days after the submission was received.
What is the product code of K032194?
The FDA product code is LSL – Dna-Reagents, Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.3390.