(106 days)
ChromoCheck™ Protein C is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.
ChromoCheck™ Protein is a chromogenic assay consisting of a synthetic substrate and Protein C Activator.
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Correlation Study) |
|---|---|
| Substantial Equivalence | R² values of 0.990 and 0.994 |
| - Predictive Power (R²) | Y-intercepts: 0.632, -1.308 |
| - Accuracy (Y-intercept) | Slopes: 0.979, 1.025 |
| - Agreement (Slope) |
Note: The document does not explicitly state numerical acceptance criteria in the traditional sense (e.g., "R² must be > 0.95"). Instead, the performance demonstrated in the correlation study with the predicate device is presented as evidence for substantial equivalence, implying that these results met the FDA's criteria for such a determination. The strong correlation (high R² values and slopes close to 1 with small Y-intercepts) is the key indicator of acceptance.
Study Details
2. Sample Size and Data Provenance
- Sample Size for Test Set: 60 individual normal and pathological patient samples.
- Data Provenance: Not explicitly stated, but the submission is from a Canadian company (Precision BioLogic Incorporated, Dartmouth, Nova Scotia, Canada). The predicate device manufacturer is Swedish (Chromogenix AB, Molndal, Sweden). It's not specified where the 60 patient samples were collected, but given the context of a correlation study for a device intended for clinical use, they would be human plasma samples. The text doesn't specify if it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the document. The "ground truth" here is the measurement obtained from the predicate device (Coamatic Protein C).
4. Adjudication Method
- None explicitly stated. The study compares the new device's results directly to the predicate device's results. There's no mention of multiple interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted. This device is an in vitro diagnostic (IVD) assay, not an imaging or diagnostic aid that typically involves human readers. The comparison is between two laboratory assays.
6. Standalone Performance Study
- Yes, in essence. The correlation study evaluates the performance of the ChromoCheck™ Protein C device directly against a legally marketed predicate device (Coamatic Protein C). While it's a comparative study, the reported metrics (Y-intercept, Slope, R²) describe the standalone performance relative to a reference standard (the predicate). There's no human-in-the-loop for this type of IVD.
7. Type of Ground Truth Used
- Comparison to a Legally Marketed Predicate Device: The ground truth for this study was established by comparing the results of the ChromoCheck™ Protein C assay to the results obtained from the Coamatic Protein C, which is a legally marketed device previously cleared by the FDA (K922201). This is a common approach for establishing substantial equivalence for IVDs. The "truth" is assumed to be accurately measured by the predicate device.
8. Sample Size for Training Set
- The document does not mention a separate training set or its sample size. For an IVD assay like this, development and optimization would occur, but the provided text focuses on the performance validation (correlation study).
9. How Ground Truth for Training Set Was Established
- As no training set is explicitly mentioned, this information is not provided.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).