(77 days)
Dimension Vista™ CYSC Flex® reagent cartridge: The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.
Dimension Vista™ Protein 3 Calibrator: The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System.
Dimension Vista™ Cystatin C Control L and H: CYSC CON L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista® System.
Dimension Vista" CYSC 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™ Protein 3 Calibrator: PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary cystatin C and serum albumin of human origin.
Dimension Vista" Cystatin C Control L and H: CYSC CON L and H are lyophilized, polygeline based product with urinary proteins of human origin containing cystatin C.
Here is an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista™ CYSC Flex® reagent cartridge:
Acceptance Criteria and Study for Dimension Vista™ CYSC Flex® Reagent Cartridge
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for in vitro diagnostic devices. The acceptance criteria are implicitly defined by the goal of showing equivalent performance to the legally marketed predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The study compares the Dimension Vista™ CYSC Flex® assay against the Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System. The acceptance criteria are based on achieving strong correlation and a specific relationship between the new device and the predicate.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Dimension Vista™ CYSC Flex® vs. Predicate) |
|---|---|---|
| Number of Samples (n) | Sufficient for statistical significance (not explicitly stated) | 160 |
| Slope | Close to 1.0 (indicating proportional agreement) | 1.005 |
| Intercept | Close to 0.0 (indicating no significant systematic bias) | 0.005 |
| Correlation Coefficient | Close to 1.0 (indicating strong linear relationship) | 0.998 |
Conclusion: The reported device performance meets the implicit acceptance criteria, demonstrating a very strong correlation and comparable results to the predicate device. The slope of 1.005 is very close to 1, the intercept of 0.005 is very close to 0, and the correlation coefficient of 0.998 is indicative of excellent agreement.
2. Sample Size and Data Provenance for the Test Set
- Sample Size Used for the Test Set: 160
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given that it's a method comparison study evaluating serum and plasma samples, it's likely a prospective collection of samples to perform the comparison, or retrospective use of banked samples, but this is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth
The study described is a method comparison study between two assays, not a study requiring expert interpretation to establish ground truth for a diagnostic condition. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) does not directly apply here. The "ground truth" for the test set is effectively the results obtained from the predicate device (Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System), which is a legally marketed device.
4. Adjudication Method for the Test Set
As this is a method comparison study with a predicate device serving as the reference, an adjudication method in the context of expert consensus (like 2+1 or 3+1 for imaging studies) is not applicable. The comparison is quantitative, based on the numerical results from both assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret cases, often with and without AI assistance, to measure the impact of AI on reader performance. The Dimension Vista™ CYSC Flex® reagent cartridge is an in vitro diagnostic assay, which does not involve human interpretation in the same way.
6. Standalone (Algorithm Only) Performance
The study presented is essentially a standalone performance assessment of the Dimension Vista™ CYSC Flex® assay compared to a predicate quantitative assay. There is no human-in-the-loop component mentioned for the analytical performance determination. It's the performance of the automated system and reagents.
7. Type of Ground Truth Used
The "ground truth" for this method comparison study is the quantitative results obtained from the legally marketed predicate device: the Dade Behring N Latex Cystatin C Kit on the BN ProSpec® System. This serves as the reference standard against which the new device's performance is measured.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. This summary describes the validation study (test set), not the development or training of the assay. For an in vitro diagnostic kit, "training set" might refer to samples used during the assay development and optimization phases, which are typically not detailed in a 510(k) summary focused on validation.
9. How the Ground Truth for the Training Set Was Established
Since a training set sample size is not provided, the method for establishing its "ground truth" is also not described. For IVD assays, the "ground truth" during development often involves extensive analytical characterization, spiking experiments, linearity studies, and comparisons to established reference methods or certified reference materials, but these details are not present in this summary.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.