(101 days)
The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista® System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzymatic Creatinine (ECREA) method on the Dimension Vista® System.
The Dimension Vista® ECREA Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dimension Vista® System. The reagents contained in the Dimension Vista® ECREA Flex® reagent cartridge are: Reagent 1 - TAPS buffer, creatinase, sarcosine oxidase, HTIB; Reagent 2 - TAPS buffer, creatininase, horseradish peroxidase, 4aminophenazone, and potassium hexacyanoferrate (II),
The Dimension Vista® ECREA CAL is an ECREA CAL is a liquid, bovine serum albumin, based product containing creatinine. The kit consists of six vials, three vials per level (A, B), 2.5 mL per vial.
The provided document is a 510(k) Summary for the Siemens Healthcare Diagnostics Inc. Dimension Vista® Enzymatic Creatinine (ECREA) Flex® Reagent Cartridge and Calibrator. It establishes substantial equivalence by comparing the new device to previously cleared predicate devices. The document does not contain a detailed study proving the device meets general acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or accuracy against an established ground truth in a standalone or MRMC study. Instead, it focuses on demonstrating analytical equivalence to predicate devices.
Therefore, many of the requested categories cannot be directly extracted from this specific document as they pertain to clinical validation studies, which are not detailed here.
Here's a breakdown of what can be extracted based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance targets (e.g., "sensitivity > 90%"). Instead, it focuses on demonstrating substantial equivalence to a predicate device through comparative testing. The performance is reported in terms of the results of this comparative testing, but the specifics of that performance (e.g., regression statistics, bias, precision) are not provided in this summary. It states "Comparative testing described in the submission report demonstrates substantial equivalent performance," implying that the results met the criteria for equivalence.
| Feature | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary Statement) |
|---|---|---|
| Analytical Performance (e.g., accuracy, precision to predicate) | Performance comparable to Roche Creatinine Plus Reagent (K003261) | "Comparative testing described in the submission report demonstrates substantial equivalent performance." |
| Analytical Performance (Calibrator) | Performance comparable to Dimension® Chem I CAL (DC18B) (K860021) | "Comparative testing described in the submission report demonstrates substantial equivalent performance." |
| Measuring Range (Serum, Plasma) | Similar to predicate (0.03 - 30 mg/dL) | 0.14 - 20.0 mg/dL (Note: This is a direct comparison point, not an acceptance criteria from the text, but shows how it compares to predicate's range) |
| Measuring Range (Urine) | Similar to predicate (0.3 - 400 mg/dL) | 2.80 - 400 mg/dL (Similar note as above) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The summary refers to "comparative testing described in the submission report," implying that a test set was used, but details on sample size, country of origin, or retrospective/prospective nature are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. For an in vitro diagnostic (IVD) device like a creatinine assay, the "ground truth" is typically established by reference methods or clinical outcomes, not by expert consensus on images or clinical assessments.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD device measuring an analyte, there isn't typically an "adjudication method" in the sense of multiple experts reviewing and reaching consensus on a finding.
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
Not applicable. This device is an enzymatic creatinine assay, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The performance of the Dimension Vista® ECREA Flex® reagent cartridge and calibrator system on the Dimension Vista® System is presented as a standalone analytical device. There is no human-in-the-loop component for the measurement itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "ground truth" used for validation. However, for a creatinine assay, the ground truth for an analytical validation of substantial equivalence typically refers to:
- Results from the predicate device itself (for method comparison studies).
- Traceability to a recognized reference method (e.g., isotope dilution mass spectrometry (IDMS)) and/or certified reference materials, although this level of detail is not in the summary.
- The established accuracy and precision of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent and calibrator system, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device type.
§ 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.