(339 days)
INNOVANCE™ Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
The INNOVANCE™ Antithrombin assay utilizes a chromogenic measuring principle. An excess of factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample. Excess, uninhibited factor Xa then cleaves a specific chromogenic substrate, causing the release of a dye. The rate of the substrate cleavage is determined by the increase in the absorbance value at 405 nm.
Acceptance Criteria and Device Performance for INNOVANCE™ Antithrombin
This response summarizes the acceptance criteria and study details for the INNOVANCE™ Antithrombin device, as presented in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the desired correlation and precision statistics.
Table 1: Performance Characteristics of INNOVANCE™ Antithrombin
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Method Comparison | ||
| Slope | ~1.0 | 1.04 |
| Intercept | ~0 (close to zero) | 0.34 |
| Correlation Coefficient (R) | High, typically ≥ 0.95 (for strong correlation) | 0.944 |
| Precision | ||
| Repeatability CV (Control Plasma N) | Low | 2.8% |
| Repeatability CV (Control Plasma P) | Low | 2.6% |
| Repeatability CV (Pathological Plasma Pool) | Low | 1.9% |
| Within-device/lab CV (Control Plasma N) | Low | 3.7% |
| Within-device/lab CV (Control Plasma P) | Low | 4.5% |
| Within-device/lab CV (Pathological Plasma Pool) | Low | 3.5% |
Study Proving Device Meets Acceptance Criteria:
The study involved comparing the INNOVANCE™ Antithrombin reagent to the legally marketed predicate device, Dade Behring Berichrom™ Antithrombin III (A) reagent (K933125), on the BCS®/BCS® XP System.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: n = 284 plasma samples.
- Precision:
- Control Plasma N: Tested 80 times (reported as N=80 for precision).
- Control Plasma P: Tested 80 times.
- Pathological Plasma Pool: Tested 80 times.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a device manufactured in Germany (Dade Behring Marburg GmbH), some data might originate from Germany, but this is not confirmed. It is also not specified if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic (IVD) assay that quantifies a specific analyte (functionally active antithrombin) through a chromogenic reaction. The "ground truth" for the test samples is established by the validated results from the predicate device and the known concentrations of the control plasmas, not through expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for this IVD device is based on quantifiable measurements and a predicate device's performance, not on subjective expert assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is an in vitro diagnostic assay, not an imaging or diagnostic AI device that involves human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented (method comparison and precision) represents the standalone performance of the INNOVANCE™ Antithrombin assay without human intervention influencing the assay's quantitative result. The device is automated, and its performance is assessed independently.
7. The Type of Ground Truth Used
The ground truth for the method comparison study was established by the results obtained from the legally marketed predicate device, Dade Behring Berichrom™ Antithrombin III (A) reagent, when run on the same plasma samples. For precision studies, the ground truth was the known concentrations of the control plasmas (Control Plasma N, Control Plasma P, and a pathological plasma pool). This is an example of an established reference method/device and certified controls.
8. The Sample Size for the Training Set
Not applicable. This device is a chromogenic assay; it is not based on a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and optical detection.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of IVD device.
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).