| CLSI C39-A (Replaces C39-P) A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard |
| Recognition Date | 2004-03-08 |
| Recognition List | 009 |
| Recognition Number | 7-89 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Tracey Bosworth FDA/OMPT/CDRH/OIR/DCTD/CHTB/ 301-796-2981 Tracey.Bosworth@fda.hhs.gov |
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This document describes a designated comparison method to standardize the ionized calcium measurements made by ion-selective electrode (ISE) potentiometry.
| Regulation Number | Device Name | Device Class | Product Code |
| §862.1150 | Calibrator, Multi-Analyte Mixture | Class 2 | JIX |
| §862.1150 | Calibrator, Primary | Class 2 | JIS |
| §862.1150 | Calibrator, Secondary | Class 2 | JIT |
| §862.1145 | Atomic Absorption, Calcium | Class 2 | JFN |
| §862.1145 | Azo Dye, Calcium | Class 2 | CJY |
| §862.1145 | Cresolphthalein Complexone, Calcium | Class 2 | CIC |
| §862.1145 | Electrode, Ion Specific, Calcium | Class 2 | JFP |
| Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994. |