(176 days)
The MULTIGENT Creatinine (Enzymatic) assay is a device intended to measure creatinine levels in human serum, plasma, and urine using the ARCHITECT c8000 System and the AEROSET System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a component of various calculations for determination or estimation of creatinine clearance, glomerular filtration rate (GFR) or estimated GFR (eGFR).
MULTIGENT Creatinine (Enzymatic) Assay is an in vitro diagnostic device for the quantitative determination of creatinine in human serum, plasma, or urine. Creatinine in the sample is hydrolyzed by creatininase to creatine. Creatine is in turn hydrolyzed by creatinase to sarcosine and urea. Sarcosine from this reaction is oxidized by sarcosine oxidase to glycine and formaldehyde, with the concomitant production of hydrogen peroxide. The H2O2 reacts with 4-aminoantipyrine and ESPMT (N-Ethyl-N-sulfopropyl-m-toluidine) in the presence of peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the creatinine concentration in the sample.
Here's a breakdown of the acceptance criteria and study information for the MULTIGENT Creatinine (Enzymatic) assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating "acceptable correlation" and "acceptable cross-platform correlation" with the predicate device (Roche Creatinine Plus assay on the Hitachi 911 Analyzer) and between the two systems for the MULTIGENT Creatinine (Enzymatic) assay (AEROSET and ARCHITECT c8000). Specific correlation coefficients (r), slopes, and Y-intercepts are provided as evidence of this acceptable performance. Similarly, precision is evaluated by acceptable total %CV values, and the analytical measurement range (AMR) is established.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance (MULTIGENT Creatinine Enzymatic) |
|---|---|---|
| Method Comparison (vs. Predicate) | High correlation (r close to 1), slope close to 1, small Y-intercept. | AEROSET vs. Roche Creatinine Plus (Hitachi 911): |
| Serum: r = 0.999, slope = 1.000, Y-intercept = -0.015 mg/dL | ||
| Urine: r = 0.999, slope = 0.964, Y-intercept = -1.03 mg/dL | ||
| ARCHITECT c8000 vs. Roche Creatinine Plus (Hitachi 911): | ||
| Serum: r = 0.999, slope = 1.011, Y-intercept = -0.100 mg/dL | ||
| Urine: r = 1.000, slope = 0.986, Y-intercept = 0.49 mg/dL | ||
| Cross-Platform Correlation (MULTIGENT) | High correlation (r close to 1), slope close to 1, small Y-intercept. | ARCHITECT c8000 vs. AEROSET: |
| Serum: r = 0.999, slope = 1.011, Y-intercept = -0.079 mg/dL | ||
| Urine: r = 1.000, slope = 1.022, Y-intercept = -0.49 mg/dL | ||
| Precision (20-day inter-assay total %CV) | Acceptable low %CV values. | AEROSET: |
| Serum Level 1 (0.647 mg/dL): 1.95% | ||
| Serum Level 2 (1.826 mg/dL): 1.30% | ||
| Serum Level 3 (6.606 mg/dL): 0.72% | ||
| Urine Level 1 (68.769 mg/dL): 1.31% | ||
| Urine Level 2 (121.937 mg/dL): 1.23% | ||
| ARCHITECT c8000: | ||
| Serum Level 1 (0.654 mg/dL): 3.17% | ||
| Serum Level 2 (1.827 mg/dL): 1.72% | ||
| Serum Level 3 (6.604 mg/dL): 0.95% | ||
| Urine Level 1 (69.940 mg/dL): 1.46% | ||
| Urine Level 2 (124.724 mg/dL): 1.16% | ||
| Analytical Measurement Range (AMR) Claim | Established lower and upper linearity limits. | Serum AMR Claim: 0.10 to 40.00 mg/dL |
| Urine AMR Claim: 2.50 to 400.00 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the number of samples (test set size) used for the method comparison or precision studies. It only mentions that "Comparative performance studies were conducted" and "Precision studies were conducted." The provenance of the data (country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. For an in vitro diagnostic (IVD) assay like this, the "ground truth" is typically established by comparative analysis against a legally marketed predicate device (Roche Creatinine Plus) and by analytical methods like IDMS traceability for calibrators, not by human experts adjudicating diagnoses.
4. Adjudication Method for the Test Set
This is not applicable for this type of IVD device. The performance is assessed through quantitative measurements and statistical comparisons, not expert adjudication.
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 is more common for imaging devices where human interpretation is involved. This device is an automated in vitro diagnostic assay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
The device is an in vitro diagnostic assay, meaning it operates standalone without human-in-the-loop performance in terms of interpretation or decision-making beyond the initial sample loading and result review. The reported performance is the standalone performance of the assay on the specified systems.
7. The Type of Ground Truth Used
The ground truth for comparison was established by:
- Comparison to a Legally Marketed Predicate Device: The Roche Creatinine Plus assay on the Hitachi 911 Analyzer served as the primary comparative standard.
- Traceability to IDMS: Both the predicate and the new assay's calibrators are traceable to IDMS (Isotope Dilution Mass Spectrometry) analysis, which is considered a gold standard for creatinine measurement.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning. This is an IVD device, and its development likely involved traditional analytical chemistry R&D and validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the machine learning sense, this question is not applicable. The assay's analytical performance (linearity, precision, correlation) is evaluated against established analytical methods and reference standards.
§ 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.