Xtag CF60 Kit V2
FDA 510(k) K083845 · Luminex Molecular Diagnostics, Inc.
Submission
- Device name
- Xtag CF60 Kit V2
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, Ontario, CA - Received
- December 24, 2008
- Decision date
- December 11, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUA – System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5900
- Specialty
- Immunology
The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic…
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|---|---|---|---|
| K163347 | xTAG Cystic Fibrosis 39 Kit v2NUA · Special | Luminex Molecular Diagnostics, Inc. | 12/15/2016SESK |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA · Special | Luminex Molecular Diagnostics, Inc. | 12/15/2016SESK |
| K083846 | Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267NUA · Traditional | Luminex Molecular Diagnostics, Inc. | 09/01/2009SE |
| K083294 | Verigene CFTR Nucleic Acid Test and Verigene CFTR Polyt Nucleic Acid TestNUA · Traditional | Nanosphere, Inc. | 07/24/2009SE |
| K090901 | Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test…NUA · Traditional | Osmetech Molecular Diagnostics | 07/06/2009SE |
| K063787 | Inplex CF Molecular TestNUA · Traditional | Third Wave Technologies, Inc. | 03/13/2008SE |
| K062028 | Cystic Fibrosis Genotyping Assay, Model 6L20-01NUA · Traditional | Celera Diagnostics | 09/07/2007SE |
| K060627 | Tag-It Cystic Fibrosis KitNUA · Special | Tm Bioscience Corporation | 06/07/2006SE |
| K060543 | Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800NUA · Special | Clinical Micro Sensors, Inc. | 03/28/2006SE |
| K051435 | Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 DNA Detection System…NUA · Traditional | Clinical Micro Sensors | 01/19/2006SE |
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| K170492 | xTAG CYP2D6 Kit v3NTI · Special | 08/11/2017SE |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2NUA · Special | 12/15/2016SESK |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA · Special | 12/15/2016SESK |
Questions and answers
When was Xtag CF60 Kit V2 cleared by the FDA?
Xtag CF60 Kit V2 (K083845) received a 510(k) decision of Substantially Equivalent on December 11, 2009, 352 days after the submission was received.
What is the product code of K083845?
The FDA product code is NUA – System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, a Class II (moderate risk) device regulated under 21 CFR 866.5900.