(60 days)
Dimension Vista® C1IN Flex® reagent cartridge: The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Dimension Vista® C1IN CAL: The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.
Dimension Vista® C1IN CON: C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).
Dimension Vista® C1IN Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® C1IN CAL: C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN).
Dimension Vista® C1IN CON: C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Method Comparison Study) |
|---|---|
| Correlation | Correlation Coefficient: 0.993 (indicating very strong linear correlation) |
| Slope | Slope of Regression: 0.915 (ideally close to 1 for perfect agreement) |
| Intercept | Intercept of Regression: 0.006 g/L (ideally close to 0 for no systematic bias) |
| Equivalence | The study "demonstrates correlation and equivalent performance" between the new and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 196 (serum and plasma samples)
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human serum and plasma samples."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical interpretation. This is a comparison study between two assays, not a diagnostic study where human readers are making interpretations.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study compares the performance of two analytical assays, not diagnostic interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study is an analytical method comparison between a new device (Dimension Vista® C1IN assay) and a legally marketed predicate device (Dade Behring N Antisera to Human C1 Inhibitor assay) on two different laboratory platforms. It does not involve human readers evaluating cases or the effect of AI assistance.
6. Standalone Performance Study
Yes, a standalone study was done in the sense that the performance of the Dimension Vista® C1IN assay was evaluated on its own by comparing its results to results from a predicate device. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It's not "algorithm only" in the context of AI, but "device only" performance in the context of analytical measurement.
7. Type of Ground Truth Used
The "ground truth" in this context is the results obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human C1 Inhibitor assay on the BN ProSpec® System. The study aims to show that the new device produces results that are comparable or equivalent to the established method.
8. Sample Size for the Training Set
Not applicable. This is an in vitro diagnostic assay, not an AI/ML device that requires a training set in the machine learning sense. The "training" for such a device typically involves method development and optimization, but not with a distinct "training set" of patient data as understood in AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 866.5250 Complement C
1 inhibitor (inactivator) immunological test system.(a)
Identification. A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).(b)
Classification. Class II (performance standards).