(98 days)
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.
This document describes the Fujirebio Diagnostics Tumor Marker Control, a quality control product intended to monitor the precision of laboratory testing procedures for various tumor markers. It is a Class I, reserved medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's performance as a control material. Instead, its performance is measured by its equivalence to a predicate device in terms of intended use, analytes, matrix, form, and stability. The performance is reported by comparing its features and characteristics to those of the predicate devices.
| Feature / Criterion | Fujirebio Diagnostics Tumor Marker Control (Proposed Device) | Bio-Rad Lyphochek® Tumor Marker Plus Control (Predicate) / ARCHITECT HE4 Control Kit (Predicate for HE4) |
|---|---|---|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class I, reserved | Class I, reserved |
| CFR section | 862.1660 | 862.1660 |
| Product Code | JJY | JJY |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | Assayed control serum to monitor the precision of laboratory testing procedures for AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA. | Assayed quality control serum to monitor precision for analytes listed in package insert (Lyphochek). Verification of accuracy and precision for ARCHITECT i System (HE4). |
| Matrix | Human Serum | Human Serum (Lyphochek); Protein buffer (ARCHITECT HE4) |
| Form | Lyophilized | Lyophilized (Lyphochek); Liquid (ARCHITECT HE4) |
| Analytes | AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, HE4, PSA, Free PSA | AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, PSA, Free PSA (Lyphochek); HE4 (ARCHITECT HE4) |
| Stability - Reconstituted at 2-8°C | 14 days at 2-8°C, except Free PSA (7 days) | 14 days at 2-8°C, except Free PSA (7 days) |
| Number of Levels | 2 | 3 |
| PSA Stability (reconstituted) | Total PSA - 14 days, Free PSA - 7 days | Total PSA – 7 days, Free PSA - 7 days |
| Reconstitution Volume | 3.0 mLs | 2.0 mLs |
| Additional Analytes | HE4 (Human Epididymis Protein 4) | ACTH, Aldosterone, Beta-2-Microglobulin, CA 27.29, Calcitonin, hCG, Prolactin, Prostatic Acid Phosphatase, and Thyroglobulin (Lyphochek) |
| Stability (unopened) | 18 months at 2-8°C | 3 years at 2-8°C (Lyphochek); 9 Months (ARCHITECT HE4) |
| Stability - Reconstituted at 2-8°C | CEA and Total PSA 14 days at 2-8°C | CEA 11 days at 2-8°C, Total PSA 7 days at 2-8°C |
| **Stability - Reconstituted at |
§ 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.