(254 days)
For in vitro diagnostic use as a control for calibration verification of the IMMULITE® Unconjugated Estriol (uE3) assays on the IMMULITE 1000, 2000 systems.
The calibration verification material is assayed control with four levels. The analyte levels for IMMULITE 1000 are 0.00, 0.16, 2.70 and 11.2 ng/ml, and 0.00, 0.19, 2.90 and 12.00 for IMULITE 2000 systems. The matrix is estriol in processed horse serum.
One set of four vials, 2 mL each, containing low, intermediate and high levels of unconjugated estriol in processed horse serum, with preservative, and an unconjugated estriol free sample. The calibration verification material (CVM) is supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. CVM's are for single use only, immediately after opening, and discard after use.
Here's a breakdown of the acceptance criteria and the study details for the IMMULITE® Unconjugated Estriol (uE3) Calibration Verification Material, based on the provided 510(K) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device revolve around the precision and accuracy of the assigned values for the Calibration Verification Materials (CVMs) across different platforms.
| Parameter | Acceptance Criteria (IMMULITE/IMMULITE® 1000) | Reported Device Performance (IMMULITE/IMMULITE® 1000) | Acceptance Criteria (IMMULITE® 2000) | Reported Device Performance (IMMULITE® 2000) |
|---|---|---|---|---|
| CVM 1 (0 ng uE3/mL) | Range: 0 - 0.07 ng uE3/mL | CVM 1 = 0.0 ng/mL (Target) | Range: 0 - 0.07 ng uE3/mL | CVM 1 = 0.0 ng/mL (Target) |
| Precision: NA | Consistent with 0 target | Precision: NA | Consistent with 0 target | |
| CVM 2 (Target u: 0.16 ng uE3/mL) | Range: 0.07 - 0.25 ng uE3/mL | Within range (based on value assignment) | Range: 0.09 - 0.29 ng uE3/mL | Within range (based on value assignment) |
| Precision: |
§ 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.