(142 days)
IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use. Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.
IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.
Here's a breakdown of the acceptance criteria and study information for the IMUBIND® tPA ELISA device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for regression values or CV%. However, the study aims to demonstrate "substantial equivalence" to a predicate device. The performance data presented serves to support this claim by showing a high correlation and acceptable precision.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Method Comparison: | |
| Correlation with predicate device | Lot 1: Y=0.79x--0.6, R=0.904, Sy.x=4.42 ng/ml (Sample Range: 1.6-18.0 ng/ml) |
| Lot 2: Y=0.83x+0.3, R=0.90, Sy.x=1.26 ng/ml (Sample Range: 3.1-23.2 ng/ml) | |
| Precision: | |
| Intra-Assay Variability (CV%) | Lot 1: 3.7% (6.8 ng/ml), 4.1% (15.4 ng/ml) |
| Lot 2: 4.9% (6.5 ng/ml), 4.2% (14.9 ng/ml) | |
| Lot 3: 6.0% (5.6 ng/ml), 3.8% (14.6 ng/ml) | |
| Inter-Assay Variability (CV%) | Lot 1: 8.9% (6.8 ng/ml), 9.0% (15.4 ng/ml) |
| Lot 2: 8.2% (6.5 ng/ml), 4.0% (14.9 ng/ml) | |
| Lot 3: 6.7% (5.6 ng/ml), 2.3% (14.6 ng/ml) | |
| Substantial Equivalence: | "Similar performance and values were obtained with both devices suggesting that the method difference does not affect device equivalence." (Based on comparison across intended use, principle, reagents, storage, specimen, limitations, expected values, and performance characteristics compared to the TintElize tPA predicate device.) |
2. Sample Size Used for the Test Set and Data Provenance
-
Method Comparison (Test Set for Equivalence):
- Sample Size:
- Lot 1: 286 samples
- Lot 2: 75 samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The data appears to be from laboratory testing comparing the new device against the predicate.
- Sample Size:
-
Precision (Test Set for Repeatability/Reproducibility):
- Sample Size: N=20 per control (for both intra-assay and inter-assay, for each of the two control samples). This was across 10 runs with replicates of 4.
- Data Provenance: Not explicitly stated, but likely laboratory-generated data for internal validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The device is a quantitative immunoassay for an analyte (tPA antigen). The "ground truth" for its performance is established by comparing its measurements to a legally marketed predicate device (TintElize tPA) and by demonstrating acceptable analytical precision. There is no human interpretative component that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above. There is no human interpretation or decision-making that would require an adjudication process.
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
This is not applicable. The IMUBIND® tPA ELISA is an in vitro diagnostic assay, not an imaging or diagnostic device involving human reader interpretation or AI assistance in a clinical setting.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of an algorithm. The IMUBIND® tPA ELISA is a laboratory assay. Its "standalone" performance is established by the analytical studies (method comparison and precision) without human interpretation as part of the measurement process.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurements obtained from the predicate device (TintElize tPA) for method comparison, and expected assay values/internal controls for precision studies.
8. The Sample Size for the Training Set
This is not applicable. The IMUBIND® tPA ELISA is a laboratory assay with established biochemical principles, not a machine learning model that requires a "training set" in the conventional sense. Its development would involve reagent optimization and assay design, but not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 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).