(39 days)
CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
CONE-TROL Liquid Chemistry Control is prepared from human serum to which purified biochemical material (human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. The control is provided in liquid form for user convenience.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria for performance metrics. However, we can infer the implicit "acceptance criteria" and how the device's performance aligns with them based on the stability testing described. The primary "performance" being evaluated here is the stability of the control material over time under various storage conditions.
| Acceptance Criteria (Inferred) | Reported Device Performance (CONE-TROL Liquid Chemistry Control) |
|---|---|
| Closed Vial Stability (2-8°C): Control material remains stable for at least 30 days at 2-8°C (matching predicate). | Acceptable stability through 33 days at 2-8°C (real-time testing). |
| Open Vial Stability (2-8°C): Control material remains stable for at least 14 days at 2-8°C after opening (matching predicate). | Acceptable stability through 15 days at 2-8°C after opening and simulating handling (real-time testing). |
| **Shelf Life (Frozen |
§ 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.