(56 days)
A creatinine test system is a device intended to measure creatinine levels 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
Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample.
This submission describes the Abbott Laboratories Creatinine assay. This is an in vitro diagnostic assay used for the quantitative analysis of creatinine in human serum, plasma, or urine and is substantially equivalent to the Roche Creatinine assay (K941837) on the Hitachi 917 Analyzer.
1. Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Predicate Device K941837) | Device Performance (Abbott Creatinine Assay) |
|---|---|---|
| Correlation Coefficient (r) | Implied acceptable correlation (based on substantial equivalence claim) | Serum: 0.9996 (AEROSET), 0.9993 (ARCHITECT c8000) |
| Slope | Implied acceptable correlation (based on substantial equivalence claim) | Serum: 0.98 (AEROSET), 0.96 (ARCHITECT c8000) |
| Y-intercept | Implied acceptable correlation (based on substantial equivalence claim) | Serum: -0.19 mg/dL (AEROSET), -0.24 mg/dL (ARCHITECT c8000) |
| Urine Correlation Coefficient (r) | Implied acceptable correlation | Urine: 0.9992 (AEROSET), 0.9990 (ARCHITECT c8000) |
| Urine Slope | Implied acceptable correlation | Urine: 0.94 (AEROSET), 0.93 (ARCHITECT c8000) |
| Urine Y-intercept | Implied acceptable correlation | Urine: -3.66 mg/dL (AEROSET), -4.16 mg/dL (ARCHITECT c8000) |
| Precision (Total %CV - Serum) | Implied acceptable precision | Level 1: 4.95% (AEROSET), 3.10% (ARCHITECT c8000) |
| Level 2: 3.18% (AEROSET), 1.54% (ARCHITECT c8000) | ||
| Precision (Total %CV - Urine) | Implied acceptable precision | Level 1: 2.41% (AEROSET), 0.94% (ARCHITECT c8000) |
| Level 2: 2.41% (AEROSET), 0.99% (ARCHITECT c8000) | ||
| Linearity (Serum) | Implied acceptable linearity | 0.20 to 37.00 mg/dL |
| Linearity (Urine) | Implied acceptable linearity | 5.0 to 740.0 mg/dL |
| Limit of Quantitation (Sensitivity - Serum) | Implied acceptable sensitivity | 0.10 mg/dL |
| Limit of Quantitation (Sensitivity - Urine) | Implied acceptable sensitivity | 2.0 mg/dL |
Note: The acceptance criteria are "implied" as the document primarily focuses on demonstrating substantial equivalence to the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by showing comparable performance characteristics rather than specifying explicit numeric thresholds for the Abbott device to meet independently.
2. Sample Size and Data Provenance (Test Set)
- Sample Size: Not explicitly stated for specific test sets in correlation or precision studies. The document refers to "comparative performance studies" and "precision studies." No specific number of patient samples or replicates is provided.
- Data Provenance: Not specified. It is likely that the data was generated internally by Abbott Laboratories during the development and validation of the assay, but the country of origin or whether it was retrospective or prospective is not mentioned.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable. This is an in vitro diagnostic assay for creatinine measurement, not an imaging device or a diagnostic algorithm requiring expert interpretation of complex data for ground truth establishment. The ground truth for this type of device is typically established by comparing its measurements to a legally marketed predicate device (as done here) or to a recognized reference method.
4. Adjudication Method (Test Set)
Not applicable. As described above, this is an in vitro diagnostic assay and does not involve human interpretation or adjudication processes for its test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic assay, not a device designed to assist human readers in interpreting medical images or other findings where an MRMC study would be relevant.
6. Standalone Performance Study
Yes, standalone performance studies were conducted to evaluate the Abbott Creatinine assay on the AEROSET and ARCHITECT c8000 Systems.
- Correlation Studies: Demonstrated the assay's performance against the predicate device (Roche Creatinine assay on Hitachi 917 Analyzer) by reporting correlation coefficients, slopes, and Y-intercepts.
- Precision Studies: Evaluated the reproducibility of the assay by reporting total %CV at different concentration levels.
- Linearity Studies: Established the range over which the assay provides accurate measurements.
- Limit of Quantitation (Sensitivity): Determined the lowest concentration that can be reliably measured.
These studies assess the algorithm's (or assay's) performance independently of human intervention.
7. Type of Ground Truth Used
The ground truth or reference standard for the comparative performance studies was the Roche Creatinine assay on the Hitachi 917 Analyzer (K941837), which is a legally marketed predicate device. For precision, linearity, and sensitivity, the ground truth would be expected values from reference materials or defined concentration levels.
8. Sample Size for the Training Set
Not applicable. This is an in vitro diagnostic assay based on a chemical reaction (modified Jaffe method), not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" of such assays involves method development, optimization, and calibration using reference materials and quality controls.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this device does not utilize a "training set" in the context of AI/machine learning. The assay's chemical principles and performance are established through laboratory experimentation, calibration using known standards, and validation studies.
§ 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.