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510(k) Data Aggregation
(261 days)
K100130 PATHFAST® cTnI-II IFU, K 100130
PATHFAST® hs-cTnl-II 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 (AMI). PATHFAST® hs-cTnI-II is for use in clinical laboratory or point of care (POC) settings.
The PATHFAST® hs-cTnI-II test is a chemiluminescent enzyme immunoassay performed on the PATHFAST® instrument. Patient samples, whole blood or plasma, are dispensed by the operator into the designated area on the reagent cartridge. The instrument combines the patient sample, the antibody coated magnetic particles, and the alkaline phosphatase conjugate and incubates the mixture for 5 minutes at 37℃. During this incubation, the analyte in the patient sample binds to the antibody on the coated particles, and the alkaline phosphatase conjugate binds to the analyteantibody coated-particle. After the incubation, the instrument performs Bound/Free (B/F) separation using Magtration® technology to remove any excess unbound reagents. The chemiluminescent substrate is then added. The substrate is catalyzed by the bound alkaline phosphatase, which results in emission of photons. The photo-multiplier tube in the PATHFAST® instrument detects the photons that are emitted during the reaction. The chemiluminescent count is converted to analyte concentration values by the instrument based on the master calibration curve for the reagent lot. The PATHFAST® hs-cTnI-II test is supplied in reagent kits. Each kit contains sufficient materials for 60 determinations. The calibrator materials are included with the reagent kit and are also available separately. Calibration kits and diluent kits are also provided separately.
The provided text describes the regulatory clearance of the PATHFAST® hs-cTnI-II device, a diagnostic test for cardiac Troponin I (cTnI), and its comparison to a legally marketed predicate device (PATHFAST® cTnI-II, K100130). The focus of this document is on the analytical performance and how modifications to the reporting range do not affect clinical performance, relying on data from the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are tied to its analytical performance and how it meets the claims for its intended use, especially concerning linearity, detection limits, and maintaining the clinical significance established by the predicate.
| Acceptance Criterion | Reported Device Performance (PATHFAST® hs-cTnI-II) |
|---|---|
| Linearity/Reportable Range | Linearity for the interval from 4.1 to 50,000 ng/L, with deviations from linearity within ±10%. (Maximum absolute deviation observed was 9.7%). |
| Limit of Blank (LoB) | 1.466 ng/L (for EDTA WB, Plasma, LiHep WB, LiHep Plasma) |
| Limit of Detection (LoD) | 2.991 ng/L (EDTA WB), 2.958 ng/L (EDTA Plasma), 2.942 ng/L (LiHep WB), 3.002 ng/L (LiHep Plasma) |
| Limit of Quantitation (LoQ) | 4.1 ng/L (for EDTA WB, Plasma, LiHep WB, LiHep Plasma) - defined as the minimum cTnI concentration with % CV |
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(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.
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