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510(k) Data Aggregation
(245 days)
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
The L-Type Creatinine-M is an in-vitro assay 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.
L-Type Creatinine M is a reagent kit for creatinine assay based on the enzymatic method employing creatininase, creatinase, sarcosine oxidase and N-(3-sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) as a new color agent.
Here's a breakdown of the acceptance criteria and study information for the L-Type Creatinine M device, based on the provided text:
Acceptance Criteria and Device Performance
The core of the acceptance criteria for the L-Type Creatinine M device is its substantial equivalence to the predicate device, Wako Creatinine HA. This is demonstrated through similar performance characteristics, particularly in correlation, linearity, and precision.
| Acceptance Criteria Category | Specific Criteria/Target Performance | Reported Device Performance (L-Type Creatinine M) |
|---|---|---|
| Correlation with Predicate | "Similar Performance Characteristics" (specifically comparing to Wako Creatinine HA) | Serum Application: Correlation coefficient of 0.999, slope of 1.049, Y-intercept of -0.35 mg/dL |
| Urine Application: Correlation coefficient of 0.998, slope of 1.038, Y-intercept of -0.94 | ||
| Linearity (Serum/Plasma) | Similar to predicate (predicate: 0-25 mg/dL) | 0.2-100 mg/dL (Wider range than predicate) |
| Linearity (Urine) | Similar to predicate (predicate: 0-25 mg/dL) | 1.0-200 mg/dL (Wider range than predicate) |
| Lower Limit of Detection (LLD) | Similar to predicate (predicate: 0.0 mg/dL) | Serum/Plasma: 0.03 mg/dL |
| Urine: 0.06 mg/dL | ||
| Within-run Precision | Not explicitly stated as a numerical target, but "good precision" implied. | Serum/Plasma: %CV ranged from 0.42 to 2.38 (n=21, 3 levels of controls) |
| Urine: %CV ranged from 0.41 to 0.68 (n=21, 3 levels of controls) | ||
| Total Precision | Not explicitly stated as a numerical target, but "good precision" implied. | Serum/Plasma: %CV ranged from 0.40 to 1.59 (over 21 days according to CLSI EP5-A1) |
| Urine: %CV ranged from 0.37 to 0.50 (over 21 days according to CLSI EP5-A1) | ||
| Serum/Plasma Sample Comparison | "Similar results" when comparing serum and plasma samples run with the new method. | Correlation coefficient of 0.999, slope of 1.002, Y-intercept of -0.04 |
Study Details
Based on the provided text, the study focuses on analytical performance characteristics rather than clinical evaluation with human subjects.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of individual patient samples. The correlation studies likely involved a range of samples to cover the linearity range. Precision studies used "3 levels of controls" with n=21 for within-run and data collected over 21 days for total precision.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory-based analytical performance evaluations, not involving retrospective or prospective human clinical data in the traditional sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic (IVD) assay where "ground truth" for analytical performance is established through reference methods and reference materials, not expert consensus on human images or clinical outcomes.
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Adjudication method for the test set: Not applicable. As an IVD assay's analytical performance study, there's no adjudication process as would be found in image-based diagnostic or clinical trial settings.
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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 is an IVD assay, not an AI-assisted diagnostic imaging device that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the entire study describes the standalone analytical performance of the L-Type Creatinine M assay. It is an "algorithm only" in the sense that it's an automated chemical assay without human interpretation of results influencing its fundamental analytical performance.
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The type of ground truth used:
- For the correlation studies comparing to the predicate (Creatinine HA), the "ground truth" is essentially the results obtained from the predicate device (Wako Creatinine HA), which is a legally marketed device with established performance.
- For linearity studies, the ground truth is established by preparing known concentrations of creatinine.
- For precision studies, the ground truth is the "true" or assigned value of the control materials used.
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set. Its "training" involves the chemical formulation and optimization of the reagents.
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How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of device development for this type of IVD, as mentioned above.
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