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510(k) Data Aggregation
(107 days)
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
The VisuLize™ Factor VIII Antigen Kit is an Enzyme Immunoassay for the quantitative determination of Factor VIII Antigen in human plasma samples and Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA)
The VisuLize™ Factor VIII Antigen kit is a sandwich enzyme-linked immuno-sorbent assay (ELISA) using a polyclonal antibody coated 96-microwell format. Plasma samples are diluted and applied to the pre-coated wells. After washing away unbound proteins, a horseradish peroxidase (HRP) labelled polyclonal antibody is applied to detect the captured Factor VIII. A chromogenic substrate (TMB) is added to allow for color development. The color formed is measured spectrophotometrically at 450 nm, with the absorbance being directly proportional to the concentration of Factor VIII that was in the sample.
Here's a breakdown of the acceptance criteria and study information for the VisuLize™ Factor VIII Antigen Kit, based on the provided text:
Acceptance Criteria and Device Performance Study for VisuLize™ Factor VIII Antigen Kit
The study compares the performance of the VisuLize™ Factor VIII Antigen Kit (Proposed Device) against the Coamatic® Factor VIII assay (Predicate Device). The primary focus for demonstrating substantial equivalence is correlation in clinical performance, as well as technical performance metrics.
1. Acceptance Criteria and Reported Device Performance
The provided text doesn't explicitly state numerical "acceptance criteria" but rather presents a comparison of performance characteristics and clinical correlation results, implying that demonstrating equivalent performance to the predicate device is the overarching acceptance criterion.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Proposed Device Performance |
|---|---|---|
| Assay Principle | Quantitative determination (in IU/mL) of Factor VIII activity by Factor Xa chromogenic activity assay. | Quantitative determination (in IU/mL) of Factor VIII antigen by sandwich ELISA (polyclonal - polyclonal HRP) |
| Intended Use | For the photometric determination of factor VIII activity in plasma such as when identifying factor VIII deficiency or monitoring patients on replacement therapy as well as for potency estimation of FVIII concentrates. | An enzyme immunoassay for the quantitative determination of Factor VIII antigen in human plasma samples and Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA). |
| Technology | Chromogenic based assay | Double antibody enzyme linked immuno-sorbent assay (ELISA) |
| Sample Matrix | Human plasma derived from blood (9 vol blood mixed with 1 vol 0.1mol/L citrate) | Human plasma derived from blood collected into 3.2% buffered citrate |
| Intra-assay precision (CV%) | 2.4 – 3.0% | 2.97 – 6.77% (mean results) |
| Inter-assay precision (CV%) | 2.1 – 5.9% | 3.38 – 6.66% (mean results) |
| Linearity | Linear curve | Log-log curve, R² ≥ 0.990 |
| Detection Limit | Normal range: 0.05 IU/mL, Low range: 0.005 IU/mL | 0.008 IU/mL (0.8%) |
| Traceability of Calibrator Plasma | Not provided with kit. | Calibrator plasma is standardized against a secondary standard that is traceable to the WHO International Standard for Factor VIII Antigen |
| Clinical Correlation (r) | High correlation with predicate device (not numerically defined as an acceptance criterion but demonstrated by predicate r values implicitly) | 0.968 (Internal), 0.964 (External Site #1), 0.974 (External Site #2) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes:
- Internal Testing: 142 samples
- External Testing Site #1: 100 samples
- External Testing Site #2: 81 samples
- Data Provenance: The data was collected through "internal" testing and "two external testing sites." The country of origin is not explicitly stated, but the applicant (Affinity Biologicals Inc.) is based in Canada. The nature of the samples ("clinical samples across the entire detection range") suggests they are human plasma samples. It is not specified if the data is retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The term "ground truth" is not directly applicable in the sense of expert consensus for image or diagnosis interpretation here. For this type of in vitro diagnostic device (ELISA kit), the "ground truth" for the test set is established by the measurements obtained from the predicate device. The study compares the results of the proposed device against the predicate device on the same clinical samples. Therefore, there are no "experts" establishing a ground truth in the traditional sense; rather, the predicate device serves as the reference standard.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the predicate device serves as the reference, not a human-adjudicated ground truth. The comparison is quantitative, based on correlation coefficients.
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
No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic (IVD) kit that measures a biomarker (Factor VIII antigen) directly, not for an AI-assisted diagnostic tool that aids human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study is a standalone performance evaluation of the IVD kit. The performance metrics (precision, linearity, detection limit, and clinical correlation) directly reflect the kit's ability to measure Factor VIII antigen. It's a "kit-only" performance assessment without explicit human-in-the-loop interaction affecting the measurement results.
7. The Type of Ground Truth Used
The "ground truth" is the results obtained from the predicate device (Coamatic® Factor VIII assay) on the same clinical samples. The study demonstrates correlation between the proposed device's measurements and the predicate device's measurements.
8. The Sample Size for the Training Set
The document does not mention an explicit "training set" or its size. For an IVD kit like this, the development process involves internal validation and optimization, but the concept of a "training set" as used in machine learning is not directly applicable here. The data presented is for the performance evaluation or "test set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no explicit training set is described in the provided information.
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