Definition: A Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection System Is Used To Qualitatively Detect Constitutional Gains And Losses In Chromosomal Copy Numbers Across The Human Genome Using Microarray Methods. It Is Intended As An Aid
| Device Type ID | 3102 |
| Device Name | System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection |
| Physical State | The Test System Consists Of A Multiplex Qualitative Amplification Based Test System Which May Utilize Different Types Of Microarrays And/or Probes To Represent The Whole Genome. The Device May Integrate Scanning, Reagent Handling, Hybridization, Wash |
| Technical Method | The Test System Uses Amplification Of Extracted Genomic DNA Followed By Hybridization Of The Amplified, Labeled Fragments To Homologous Probes On A Microarray. The System Uses Signal Intensities From The Bound Probes As The Basis For Determination Of |
| Target Area | Human Peripheral Whole Blood Or Clinical Samples |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5920 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 3102 |
| Device | System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection |
| Product Code | PFX |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.5920 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AGILENT TECHNIOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AGILENT TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFE TECHNOLOGIES | ||
GRANTED | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Affymetrix Inc | III | Jun-03-2016 |