(143 days)
The CoaguChek Pro ACT test is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System.
The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.
The activated clotting time test is used to measure coagulation by activating the clotting pathway. The ACT test monitors the effectiveness of heparin during several types of medical procedures. Many procedures such as Percutaneous Transluminal Coronary Angioplasty (PTCA), cardiac catheterization, hemodialysis, and Extracorporeal Membrane Oxygenation (ECMO) require the administration of low to moderate heparin doses. Sensitivity to heparin can vary significantly from patient to patient, and lack of adequate control of the heparin dose can lead to either bleeding or thrombosis.
The ACT test is initiated by inserting a CoaguChek Pro ACT test cartridge into the instrument. The instrument reads a code on the test cartridge to determine test identity and lot number. The test cartridge contains a sample application well, a reagent chamber, and a reaction path. After the instrument heats the test cartridge, a drop of fresh, whole blood is placed on the test cartridge sample application well. Blood is drawn into the reagent chamber by capillary action, where it mixes with the reagent to initiate coagulation. The blood sample moves along the reaction path until a clot forms. The laser optical system detects the clot by monitoring blood flow; endpoint is reached when the blood stops moving. The time from sample application to clot detection is the activated clotting time. The displayed result is equivalent to the ACT result obtained from a commercially available system. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key.
Here's a summary of the acceptance criteria and the study details for the ACT Test and Controls for the CoaguChek Pro System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied vs. Predicate) | Reported Device Performance (CoaguChek Pro ACT Test) |
|---|---|---|
| Mean Normal | Similar to Predicate (132 seconds) | 112 seconds |
| Verified Hematocrit Range | Not in predicate labeling | 27 – 54% |
| Precision with Liquid Controls | Similar to Predicate | Level 1: Mean 115.06 sec, CV 5.79% |
| Level 2: Mean 401.02 sec, CV 10.34% | ||
| Precision with Blood | Not in predicate labeling | Using arterial whole blood, duplicate results gave CVs of 6% or better. |
| Accuracy | Not in predicate labeling | Arterial Whole Blood: |
| N=539 | ||
| Y = 0.953X + 5.3 | ||
| R = 0.883 (where Y is CoaguChek Pro and X is Hemochron) | ||
| Heparin Range | Predicate has "Every level of heparin anticoagulation, from prophylaxis to intensive" | 0-3 U/mL (a specified range, which is a difference from the predicate) |
| Maximal Test Time | Predicate is 1,500 seconds | 500 seconds (a difference from the predicate) |
Note: The document implies acceptance criteria by comparing the performance characteristics to a predicate device. Specific numerical "acceptance criteria" are not explicitly stated for each characteristic in the way they might be in a formal test plan. Instead, the comparison to the existing predicate device's performance (or lack thereof, for new metrics) serves as the basis for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Accuracy: N=539 (for arterial whole blood comparison against the Hemochron).
- Precision with Blood: Not explicitly stated as a number of samples, but mentions "duplicate results."
- Precision with Liquid Controls: Not explicitly stated, implied to be sufficient for calculating Mean and CV for two levels.
- Data Provenance: Not explicitly stated but clinical studies are generally considered prospective or a mix. The document does not specify country of origin for the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This device is an in-vitro diagnostic (IVD) based on measuring a physiological parameter (activated clotting time). The "ground truth" is established by the reading from a predicate device (Hemochron ACT Test) or by the inherent measurement of the physical phenomenon of clotting.
- Therefore, the concept of "experts establishing ground truth" in the same way it would apply to image interpretation (e.g., radiologists) does not directly apply here. The accuracy study compares the device's reading to that of a reference method (the predicate device).
4. Adjudication Method for the Test Set
- Not applicable as this is a quantitative measurement device compared against a predicate device, not an interpretation where multiple human experts would adjudicate a finding.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic aids where human interpretation is involved.
- The study performed was a direct comparison of the device's quantitative output against a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the study presented for "Accuracy" and "Precision" reflects the standalone performance of the CoaguChek Pro ACT Test system (instrument and cartridge). The device automatically detects the clot and reports the time, without human intervention in the measurement process itself, although a human initiates the test and reads the result.
7. The Type of Ground Truth Used
- Comparative Ground Truth: The primary "ground truth" for the accuracy study was the measurement obtained from the predicate device, the Hemochron ACT Test. The study aimed to show substantial equivalence through correlation.
- For precision, the "ground truth" is the reproducibility of the device's own measurements.
8. The Sample Size for the Training Set
- The document does not specify a separate "training set" size. For IVD devices like this, the development likely involves various stages of internal testing and calibration. The data presented here is for validation (test set).
9. How the Ground Truth for the Training Set Was Established
- Not described in the provided 510(k) summary. For devices of this nature, the "ground truth" for training (e.g., calibrating the device or developing the algorithm for clot detection) would typically involve using known samples or primary reference methods to ensure accurate and precise measurement of the activated clotting time.
§ 864.7140 Activated whole blood clotting time tests.
(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).