21 CFR 862.1660 — Electrolyte Controls (Assayed And Unassayed)
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1660
Identification
A quality control material (assayed and 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 instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification Rationale
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 | 17 | |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 67 | |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 97 | |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 61 | |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 493 | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 673 | |
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | 1 | 9 | |
| MJX | Kit, Serological, Positive Control | 1 | 7 | |
| MJY | Kit, Serological, Negative Control | 1 | 1 | |
| MJZ | Kit, Direct Antigen, Positive Control | 1 | 3 | |
| MKA | Kit, Direct Antigen, Negative Control | 1 | 0 | |
| OHQ | Multi-Analyte Controls Unassayed | 1 | 0 | |
| OLD | Internal Polymerase Chain Reaction Control, Not Assay Specific | 1 | 1 |
