(257 days)
The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3® System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, chronic interstitial nephritis and as an indicator of glomerular filtration rate.
The Device is a Reagent containing alkaline picrate for the determination of creatinine for optimum system operation on the Beckman Synchron CX3® System.
Here's an analysis of the provided text regarding the GenChem Creatinine Test Reagent, structured to address your specific questions.
It's important to note that this document is a 510(k) Summary for an in vitro diagnostic (IVD) reagent, not an AI/ML device. Therefore, many of your questions related to AI-specific aspects (such as ground truth establishment by experts, adjudication methods, MRMC studies, training set, etc.) are not applicable to this type of submission. The performance criteria for IVDs typically revolve around analytical performance characteristics.
Acceptance Criteria and Device Performance for GenChem Creatinine Test Reagent
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate)** | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Comparable to predicate device (Beckman Creatinine Reagent for the CX3) and acceptable for clinical use. | Serum 1: Mean 0.5 mg/dL, Within Run SD 0.05, %CV 9.8, Total SD 0.05, %CV 9.8 |
| Serum 2: Mean 4.0 mg/dL, Within Run SD 0.02, %CV 0.5, Total SD 0.02, %CV 0.5 | ||
| Serum 3: Mean 7.4 mg/dL, Within Run SD 0.03, %CV 0.5, Total SD 0.05, %CV 0.7 | ||
| Urine 1: Mean 40.3 mg/dL, Within Run SD 0.41, %CV 1.0, Total SD 0.56, %CV 1.4 | ||
| Urine 2: Mean 222.9 mg/dL, Within Run SD 2.29, %CV 1.0, Total SD 2.79, %CV 1.3 | ||
| Linearity/Reportable Range | Demonstrates linearity across the clinical range and comparable to predicate. | Slope 0.994, Intercept -0.05, Standard Error of Estimate 0.11, r = 1.00 |
| Serum/Plasma: 0.2 to 25 mg/dL | ||
| Urine: 10 to 400 mg/dL | ||
| Sensitivity | Detects creatinine at clinically relevant low levels. | 0.2 mg/dL (claimed limit), observed sensitivity 0.01 mg/dL (lower is better) |
| Analytical Specificity (Interference) | No significant interference from common exogenous or endogenous substances at tested concentrations. | No adverse effect on 1.1 mg/dL creatinine sample from: |
| Hemoglobin up to 500 mg/dL | ||
| Bilirubin up to 20 mg/dL | ||
| Lipemia up to 1800 mg/dL | ||
| Method Comparison (Patient Samples) | Results compare favorably with the predicate device on patient samples, demonstrating substantial equivalence. | Serum: Intercept 0.0, Slope 0.991, R2 0.997 (N=80, Range 0.4 - 30.4 mg/dL) |
| Plasma: Intercept 0.05, Slope 0.998, R2 0.998 (N=80, Range 0.4 - 30.4 mg/dL) | ||
| Urine: Intercept -0.3, Slope 1.000, R2 1.000 (N=79, Range 12.1 - 400 mg/dL) |
Notes on Acceptance Criteria:
- For IVD devices seeking 510(k) clearance, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device. This means the new device must perform as well as or better than the predicate, or perform similarly without raising new questions of safety or effectiveness.
- The document implies that the "acceptance criteria" for each performance characteristic were that the results should be consistent with the expected performance for a creatinine assay and demonstrate equivalence to the predicate device (Beckman Creatinine Reagent for the CX3). Specific numeric acceptance thresholds are not explicitly stated as they might be for a novel device, but rather implied by the successful comparison to the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Precision/Reproducibility:
- Serum samples: 60 data points each for Serum 1, Serum 2, Serum 3 (assayed twice per day in triplicate over 10 days).
- Urine samples: 59 data points for Urine 1, 60 data points for Urine 2 (assayed twice per day in triplicate over 10 days).
- Data Provenance: Not explicitly stated, but likely from laboratory-prepared control sera/urine pools. This would be considered retrospective in the sense that the controls were pre-defined, but the testing was prospective.
- Linearity: Commercially available linearity standards (0 to 25.7 mg/dl) analyzed in triplicate. Not specified how many distinct standards were used beyond the range.
- Sensitivity: A diluted serum control was used, with 21 replicates for the within-run precision study.
- Analytical Specificity: Stock samples with 1.1 mg/dL creatinine were tested. Not specified how many replicates or distinct samples.
- Patient Comparison:
- Serum: 80 patient samples (ranging from 0.4 to 30.4 mg/dl).
- Plasma: 80 patient samples (ranging from 0.4 to 30.4 mg/dl).
- Urine: 79 patient samples (ranging from 12.1 to 400 mg/dL).
- Data Provenance: "collected from adult patients." This would be considered prospective data collection for the method comparison study. Country of origin is not specified but presumed to be the USA, given the FDA submission.
3. 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) reagent for chemical analysis, not an AI/ML device that requires expert human interpretation of images or other subjective data to establish ground truth. The "ground truth" for an IVD device's performance is established by the analytical method (e.g., using known concentrations in linearity standards, measuring against a reference standard in patient comparison studies using a legally marketed predicate device).
4. Adjudication Method for the Test Set:
- Not Applicable. See explanation in point 3. Adjudication is typically used to resolve discrepancies in human expert interpretations, which is not relevant for this type of device.
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 is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is an IVD reagent, not an algorithm. The device is the reagent; its performance is in its chemical reaction and subsequent detection, which is inherently "standalone" in its analytical function (meaning it provides a result without human interpretation of the underlying chemistry).
7. The Type of Ground Truth Used:
- Analytical Reference/Comparative Method:
- Precision: Statistical calculations (SD, %CV) from repeated measurements of control materials with known or expected values.
- Linearity/Sensitivity: Measurements against commercially available linearity standards or diluted controls with known concentrations.
- Analytical Specificity: Measurements of samples spiked with known interferents against an unspiked control sample.
- Patient Comparison: The "ground truth" in this context is the result obtained from the predicate device (Beckman Creatinine Reagent on the SYNCHRON CX3® System). The study aimed to show that the GenChem reagent produced results that were statistically equivalent to those produced by the predicate device when testing the same patient samples.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set. The "development" of the reagent would involve chemical formulation and optimization, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See explanation in point 8.
§ 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.