Definition: A Quality Control Material (unassayed) For Clinical Chemistry Is A Device Intended For Medical Purposes For Use In A Test System To Estimate Test Precision And To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instr
| Device Type ID | 642 |
| Device Name | Multi-analyte Controls Unassayed |
| Physical State | Quality Control Material |
| Technical Method | Quality Control Material |
| Target Area | In Vitro Diagnostic |
| 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) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OHQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 642 |
| Device | Multi-analyte Controls Unassayed |
| Product Code | OHQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| CFR Regulation Number | 862.1660 [🔎] |
| Device Problems | |
|---|---|
Human Factors Issue | 2 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 3 |