(102 days)
The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCULLECT i2000gg System when used for the quantitative determination of cardiac Troponin-1 in human serum and plasma. Refer to the ARCHITECT STAT Troponin-1 reagent package insert for additional information.
ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H
1. Acceptance Criteria and Reported Device Performance:
This document is a 510(k) clearance letter for a quality control material, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, the concept of "acceptance criteria" for a diagnostic accuracy study and "reported device performance" are not directly applicable in the same way they would be for a screening or diagnostic tool.
For this specific device (ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control), the primary acceptance criterion for its 510(k) clearance is substantial equivalence to a legally marketed predicate device. This means the FDA has determined that the new device is as safe and effective as a similar device already on the market.
While not explicitly stated in the provided text as "acceptance criteria" and "reported performance" in a quantitative table for a diagnostic study, the core function of a quality control material is to verify the accuracy and precision of an assay. The premarket notification would have included data demonstrating that this control material performs as expected in validating the ARCHITECT i2000sr System for Troponin-I measurements. This would typically involve:
- Stability data: Showing the control material maintains its specified concentration levels over its shelf life and under various storage conditions.
- Lot-to-lot consistency: Demonstrating that different manufacturing lots of the control material produce consistent results.
- Assigned values and expected ranges: The control material would have known target values for Troponin I that it should register within a specified range when run on the ARCHITECT i2000sr System.
2. Sample Size Used for the Test Set and Data Provenance:
This document is a regulatory clearance letter and does not contain details about specific test set sample sizes or data provenance. For a quality control material, the "test set" would be the internal validation studies conducted by the manufacturer to demonstrate the material's properties (stability, lot consistency, assigned values). Details like sample size, country of origin, and retrospective/prospective nature of these internal studies are not part of the 510(k) clearance letter's publicly available information.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As a quality control material, the "ground truth" is established by the manufacturer through rigorous analytical testing and assignment of target values for the constituents within the control. This is not a human-interpreted diagnostic task requiring expert consensus on images or clinical cases.
4. Adjudication Method for the Test Set:
Not applicable. There is no human interpretation or diagnostic decision-making involved requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. MRMC studies are used to evaluate the impact of a diagnostic device (often image-based AI) on human reader performance. This device is a quality control material, not a diagnostic tool that directly aids human readers in interpretation.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a quality control material, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. Type of Ground Truth Used:
The ground truth for a quality control material is established through analytical testing and assigned values by the manufacturer. This involves precise laboratory measurements using validated reference methods to determine the concentration of the analyte (Troponin I in this case) within the control material. There is often an expected range of values the control should fall within when run on the target instrument.
8. Sample Size for the Training Set:
Not applicable. This device is a quality 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. See point 8.
§ 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.