(133 days)
The Diagnostic Chemicals Limited Enzymatic Creatinine Assay is for the quantitative determination of creatinine in serum, 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. This device is intended for professional use and IN VITRO diagnostic use only.
The Enzymatic Creatinine Assay contains an in vitro diagnostic reagent system intended for the quantitative determination of creatinine in serum, 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. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
The provided document is a 510(k) summary for a medical device called the "Enzymatic Creatinine Assay." This document describes the device and its comparison to a predicate device, focusing on substantial equivalence for regulatory purposes. It does not present acceptance criteria in a quantitative, pre-defined manner typical of performance goals for a new device. Instead, it demonstrates performance by comparing its results to a legally marketed predicate device (Roche Diagnostics Corp. Creatinine Plus) and showing a high correlation.
Therefore, for this specific submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through strong correlation and linearity in method comparison studies.
Here's the information extracted and structured based on your request, with an emphasis on how the information is presented in the provided context:
Acceptance Criteria and Study Details for Enzymatic Creatinine Assay (K070383)
This 510(k) submission demonstrates the substantial equivalence of the Enzymatic Creatinine Assay to a predicate device, the Roche Diagnostics Corp. Creatinine Plus (K003261). The "acceptance criteria" are not explicitly stated as quantitative thresholds for performance metrics (e.g., sensitivity > 90%). Instead, the study aims to show a strong correlation and agreement with the predicate device, thereby demonstrating equivalent performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Strong linear correlation with predicate device for serum creatinine measurements. | Serum: |
| Correlation Coefficient: 1.0000 | |
| Linear Regression: This method = 1.033 (reference method) - 0.13 mg/dL | |
| (Range tested: 0.7 to 31.2 mg/dL) | |
| Strong linear correlation with predicate device for urine creatinine measurements. | Urine: |
| Correlation Coefficient: 0.9995 | |
| Linear Regression: This method = 1.041 (reference method) + 1.06 mg/dL | |
| (Range tested: 13.5 to 141.7 mg/dL) | |
| Strong linear correlation between plasma and serum creatinine measurements by the new method. | Plasma vs. Serum (using submission device): |
| Correlation Coefficient: 0.9997 | |
| Linear Regression: Plasma = 1.006 (serum) - 0.03 mg/dL | |
| (Range tested: 0.61-27.04 mg/dL) |
2. Sample Size Used for the Test Set and Data Provenance
- Serum: 40 samples
- Urine: 40 samples
- Plasma vs. Serum: 33 samples
- Data Provenance: Not explicitly stated regarding country of origin. The study describes "a comparison was made between this method and a similar enzymatic method," or "a comparison was made between plasma and serum." The context of a 510(k) from a Canadian company (Diagnostic Chemicals Limited) seeking FDA approval suggests the data would be relevant to North American populations, but this is not definitively stated. It is a retrospective method comparison study, using existing samples to compare two methods.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not mentioned. This is a comparison of two diagnostic assays, where one (the predicate) serves as the reference or "ground truth" for evaluating the other. The "ground truth" is established by the existing, legally marketed predicate device's measured values, rather than by human expert interpretation of raw data.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically used in studies where human readers interpret images or clinical data and their interpretations need to be reconciled by experts. In this analytical performance study comparing two quantitative assays, the comparison is directly between the numerical results generated by each assay. The statistical method used for comparison was Deming regression using NCCLS EP9-P.
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 assesses the performance of human readers, with and without AI assistance, typically for image-based diagnostics. This submission is for an in vitro diagnostic (IVD) assay for chemical measurement, not an AI-powered diagnostic imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone performance study was done in the sense that the device's output (creatinine concentration) was directly compared to the predicate device's output. There is no human-in-the-loop component for the measurement of creatinine itself; the device automatically produces a quantitative result. The study evaluated the analytical performance of the new assay in isolation (i.e., its ability to accurately measure creatinine compared to a reference method).
7. Type of Ground Truth Used
- The "ground truth" in this context is the measurements obtained from the predicate device (Roche Diagnostics Corp. Creatinine Plus). The study aimed to demonstrate that the new Enzymatic Creatinine Assay produces results that are highly correlated and essentially interchangeable with those from the established predicate method.
8. Sample Size for the Training Set
- The document describes a method comparison study for showing substantial equivalence, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The samples mentioned above (40 serum, 40 urine, 33 plasma) comprise the samples used to test the performance of the new device relative to the predicate.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an AI/ML model, this question is not applicable. For the performance evaluation, the "ground truth" was established by the measurements provided by the predicate device.
§ 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.