(12 days)
Architect LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott Architect i System.
Architect LH MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect LH MasterCheck Levels 1, 2, and 3 contain LH (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
I am sorry, but the provided document does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and a study proving the device meets them.
The document is a 510(k) summary for the Bio-Rad Architect LH MasterCheck, which is a control device for an LH assay. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria for the new device.
Specifically, the document does not include:
- A table of acceptance criteria for the Architect LH MasterCheck's performance.
- Reported device performance metrics against specific criteria.
- Information about sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
- Details on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human reader improvement with AI.
- Standalone algorithm performance data.
- The type of ground truth used (beyond implying it's for verifying assay performance, not a diagnostic outcome).
- Sample size for a training set.
- How ground truth for a training set was established.
The content mainly provides:
- Intended Use: Verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott Architect i System.
- Device Description: Composition of the control levels.
- Comparison to Predicate Device: A table comparing characteristics like intended use, form, matrix, storage, analytes, and open vial claim.
- Regulatory Information: 510(k) clearance letter.
Therefore, I cannot extract the requested information from this 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.