(8 days)
Architect TSH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Architect TSH MasterCheck Level 0 contains TRIS buffer with protein (bovine) stabilizers.
Architect TSH MasterCheck Levels 1, 2, 3 and 4 contain TSH (human) prepared in TRIS buffer with protein (bovine) stabilizers.
Preservative: Sodium Azide.
This document is a 510(k) summary for the Bio-Rad Laboratories Architect TSH MasterCheck. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding specific study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit "acceptance criteria" in the traditional sense of a performance study with specific metrics (e.g., sensitivity, specificity, accuracy) and corresponding thresholds. Instead, it compares the characteristics of the Bio-Rad Architect TSH MasterCheck with a predicate device to establish substantial equivalence.
The table below illustrates the comparison provided in the document:
| Characteristic | Architect TSH MasterCheck | Casco Standards Document Serum Multi-Analyte Verification Test Set (Predicate) |
|---|---|---|
| Intended Use | Verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System. | In vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range using automated, semi-automated and manual methods. |
| Form | Liquid | Liquid |
| Matrix | TRIS buffer with protein (bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | TSH | Multiple |
| Open Vial Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the Architect TSH assay | Calibration verifier for multiple analytes. |
Reported Device Performance: The document implicitly states that the device is "substantially equivalent" to the predicate, implying that its performance for its intended use (verification of sensitivity, calibration linearity, and reportable range) is comparable to the predicate device. However, specific quantitative performance metrics (e.g., how accurately it verifies linearity, or what are the limits of its sensitivity verification) are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document describes the device and compares its characteristics to a predicate, but it does not detail a specific performance study with a distinct "test set" and corresponding sample size.
- Data Provenance: Not applicable in the context of an independent performance study. The data provided are descriptive of the device's composition and intended use, and comparative information to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This document is a 510(k) summary focused on substantial equivalence. It does not describe a study involving expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
- Not applicable. There is no described test set or adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document is for an in vitro diagnostic control material (a verification test set), not an imaging or diagnostic algorithm that would typically be evaluated in an MRMC study with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. The device is a TSH MasterCheck, a control material, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable. The document describes a control material used for verifying the performance of an Abbott Architect i System. The "ground truth" in this context would refer to the expected values of the TSH levels in the control material, which are manufactured and assigned during the production process. The document does not elaborate on how these "ground truth" values for the control material itself were established, though it implies the TSH (human) is prepared in a buffer.
8. The Sample Size for the Training Set
- Not applicable. This document describes a control material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is relevant to this device's description.
In summary, this 510(k) document is for a medical device that serves as a control material. Its regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device by comparing intended use, form, matrix, storage, analytes, and open vial claims. It does not present a detailed clinical or performance study with the specific metrics and methodologies often associated with novel diagnostic algorithms or imaging devices.
§ 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.