Cystic Fibrosis Genotyping Assay, Model 6L20-01
FDA 510(k) K062028 · Celera Diagnostics
Submission
- Device name
- Cystic Fibrosis Genotyping Assay, Model 6L20-01
- Applicant
- Celera Diagnostics
Alameda, CA, US - Received
- July 18, 2006
- Decision date
- September 7, 2007
- 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 |
| K083845 | Xtag CF60 Kit V2NUA · Traditional | Luminex Molecular Diagnostics, Inc. | 12/11/2009SE |
| 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 |
| 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 |
Questions and answers
When was Cystic Fibrosis Genotyping Assay, Model 6L20-01 cleared by the FDA?
Cystic Fibrosis Genotyping Assay, Model 6L20-01 (K062028) received a 510(k) decision of Substantially Equivalent on September 7, 2007, 416 days after the submission was received.
What is the product code of K062028?
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.