Search Results

CHROMOPEP AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
CHROMOPEP PC is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.

Chromopep PC is a chromogenic assay consisting of a synthetic substrate and Protein C activator.
Chromopep AT is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer.

The provided text is a 510(k) Premarket Notification Summary for two devices, Chromopep PC and Chromopep AT, which are chromogenic assays for quantitative determination of Protein C and Antithrombin activity, respectively. These are IVD devices and the provided summary focuses on demonstrating their substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, several of the requested categories are not applicable or cannot be extracted from this document, as they typically apply to studies evaluating new medical devices and their performance against clinical endpoints or ground truth.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission for IVD assays, the "acceptance criteria" are implied by demonstrating that the new devices perform comparably to their legally marketed predicate devices. The document does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) or directly report performance metrics in the way a clinical study for a treatment device might. Instead, the performance is demonstrated through comparison to the predicate devices, implying that if they are "substantially equivalent" in design and intended use, their performance will also be equivalent and acceptable.

2. Sample size used for the test set and the data provenance:

The document does not provide details of specific test sets, sample sizes, or data provenance. The submission focuses on the design and intended use equivalence to predicate devices. It is typical for IVD submissions regarding substantial equivalence to include performance data (e.g., accuracy, precision, linearity, interference studies), but this specific summary does not present those details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. For IVD assays, "ground truth" often refers to a reference method or known concentration/activity of the analyte. The summary does not describe any expert adjudication for establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Expert adjudication methods are typically used in imaging or clinical diagnostic studies where subjective interpretation is involved. This document pertains to quantitative laboratory assays.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. MRMC studies and AI assistance are not relevant to this type of IVD chromogenic assay.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. These are laboratory reagents for quantitative assays, not AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the "ground truth" used for performance assessment. For quantitative IVD assays, ground truth typically refers to:

• Reference methods (e.g., gold standard laboratory tests).
• Certified reference materials with known analyte concentrations.
• Spiked samples with known amounts of the analyte.

The summary emphasizes the comparison to predicate devices, implying that their established performance serves as a benchmark rather than a separate ground truth study outlined here.

8. The sample size for the training set:

Not applicable. These are chemical reagents for performing assays, not machine learning or AI models that require training sets.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for these types of IVD devices.

Ask a specific question about this device