(30 days)
Architect Testosterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Architect Testosterone MasterCheck Level 0 contains bovine serum Architect Testosterone MasterCheck Levels 1, 2 and 3 contain testosterone prepared in bovine serum. Preservative: Antimicrobial agent.
The provided document is a 510(k) summary for a medical device called "Architect Testosterone MasterCheck." This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of analytical performance.
Instead, the document primarily addresses:
- Device Description: What the Architect Testosterone MasterCheck is (bovine serum with testosterone).
- Intended Use: Verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System.
- Substantial Equivalence Comparison: A table comparing its characteristics (intended use, form, matrix, storage, analytes, open vial claim) to a predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set).
- Regulatory Classification: Class I device.
- FDA Clearance: Notification of clearance for marketing based on substantial equivalence.
Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as this type of information is not present in the provided 510(k) summary.
In summary, the document does not contain the information needed to answer the questions about acceptance criteria and a study proving device performance.
§ 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.