Definition: Internal Control That Can Be Used In Real-time Polymerase Chain Reaction (pcr) Assays To Detect Systemic Variation That May Arise During The Extraction And Amplification Process Associated With Real-time Pcr Assays. It Is Not Intended To Monitor Othe
| Device Type ID | 643 |
| Device Name | Internal Polymerase Chain Reaction Control, Not Assay Specific |
| Physical State | It Is A Nonsense, Non-specific Deoxyribonucleic Acid (DNA) Sequence Cloned Into A Plasmid Vector And Supplied In A Tris Ethylenediaminetetraacetic Acid Buffer. |
| Technical Method | The Internal Control Template Is A Synthetic Deoxyribonucleic Acid (DNA) Sequence That Can Be Added To Samples Prior To Nucleic Acid Extraction. With The Addition Of Specific Primer And Probe Sets, It Is Then Amplified Along With The Target DNA Seque |
| Target Area | It Is For In Vitro Diagnostic Tests. |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OLD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |