(12 days)
Architect Prolactin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System.
Architect Prolactin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 contain prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
The provided text is a 510(k) summary for the Bio-Rad Architect Prolactin MasterCheck, a medical device intended for calibrating and verifying the performance of the Abbott Architect i System's Prolactin assay. The document does not contain details about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies in the context of an AI device.
It solely focuses on:
- Device Description: Composition and intended use of the Architect Prolactin MasterCheck.
- Substantial Equivalence Claim: Comparison to a predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set) based on intended use, form, matrix, storage, analytes, and open vial claim.
- FDA 510(k) Clearance: The letter from the FDA granting clearance for marketing.
Therefore, I cannot provide the requested information as it is not present in the given document.
§ 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.