(385 days)
The PATHFAST® cTnl Calibrators are for calibration of the PATHFAST® system when used for the quantitative determination of cardiac Troponin I in human heparinized or EDTA whole blood and plasma.
The PATHFAST cTnl Calibrators are for calibration of the PATHFAST cTnl-II test performed on the PATHFAST instrument. PATHFAST cTnI-II test is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction.
Currently, PATHAST cTnl Calibrators 1 and 2 are provided as lyophilized products of two vials each. Calibrator 1 consists of buffer only and Calibrator 2 consists of cTnI complex in buffer. Four vials of calibrator diluent also are provided for reconstitution of the calibrators. The diluent consists of an aqueous solution with 0.05% sodium azide. This Special 510(k) is being submitted for a change to a liquid Calibrator 1 formulation and a new dropper bottle container. There are no changes to PATHFAST cTnl Calibrator 2. As a result of elimination of the reconstitution step for PATHFAST cTnI Calibrator 1, the number of bottles of Calibrator Diluent is being reduced from four bottles to two bottles.
The provided document describes the PATHFAST® cTnI Calibrator 1, which underwent a Special 510(k) submission for a change in formulation from lyophilized to liquid and a new container type. The purpose of the submission is to demonstrate substantial equivalence to the predicate device (PATHFAST® cTnI Calibrator 1, lyophilized format, K100130).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed in a quantitative table. Instead, the document states that the modified device "met all specifications for the studies identified in the company's design control system Risk Analysis." The studies performed were:
| Study Area | Performance Metric | Reported Device Performance |
|---|---|---|
| Formulation | Assay sensitivity, accuracy, precision, method comparison, sample type and matrix comparison | Met all specifications |
| Format | Real-time stability | Met all specifications |
| Container | Elution and evaporation | Met all specifications |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the test sets used in the validation/verification studies. It only mentions the types of studies performed (assay sensitivity, accuracy, precision, method comparison, sample type and matrix comparison, real-time stability, elution, and evaporation).
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a calibrator, and its performance is evaluated against established analytical specifications and comparison to a predicate device, rather than through expert-established ground truth on clinical data.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device calibrator, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance
Yes, the studies conducted (formulation, format, container evaluations) represent standalone performance of the modified calibrator against its own specifications and in comparison to the predicate device's performance characteristics. The studies directly assess the analytical performance of the calibrator itself.
7. Type of Ground Truth Used
The "ground truth" for the calibrator's performance is established by:
- Analytical specifications: The device is expected to meet predefined performance targets for sensitivity, accuracy, precision, etc.
- Comparison to predicate device: The modified calibrator's performance is compared to that of the legally marketed predicate device (lyophilized format) to demonstrate substantial equivalence.
- Reference materials/methods: Implicitly, the accuracy and precision studies would rely on reference materials or methods to determine true values.
8. Sample Size for the Training Set
Not applicable. This device is a calibrator and does not involve AI/machine learning models that require training sets in the conventional sense. Its purpose is to calibrate an existing diagnostic system, not to perform a diagnostic function itself based on learned patterns.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.