(48 days)
Multichem Alc control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analyte, HbA1c, as listed in the package insert.
The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. A minimum of two levels of control are available to allow performance monitoring within the clinical range of HbA1c assay method. Multichem A1c control is prepared from human red blood cells with added chemicals and stabilizers. The control is provided in liquid form for convenience.
The provided document describes the Multichem A1c device, which is an assayed quality control material for monitoring the precision of laboratory testing procedures for HbA1c. The study described focuses on the stability and value assignment of this quality control material, rather than the performance of a diagnostic algorithm or device in detecting disease. Therefore, many of the requested categories for a diagnostic device (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, and standalone performance) are not applicable in the traditional sense.
Here's the information that can be extracted and presented based on the context of a quality control device:
1. Acceptance Criteria and Reported Device Performance
Device: Multichem A1c (Assayed) Control
Purpose: Quality Control Material for HbA1c testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Value Assignment Ranges | Level 1: |
- % HbA1c (DCCT/NGSP): Target 4.00-7.00%
- A1c (IFCC mmol/mol): Target 20.2-53.0 mmol/mol
Level 2: - % HbA1c (DCCT/NGSP): Target 8.00-13.00%
- A1c (IFCC mmol/mol): Target 63.9-119.0 mmol/mol | Value assignments performed successfully on Tosoh, Beckman, and Trinity analysers, with targets and ranges established for each. Specific targets and ranges for each level and analyzer combination are provided in Section 8.0. The control ranges are set based on 3 standard deviations of imprecision with a minimum applied range of ±10%. |
| Open Vial Stability | Maximum Allowable Degradation / Drift Limit
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. 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.