(366 days)
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MOPS buffer (pH 7.50), EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)- m -Toluidine), Creatinase (microoganism), Sarcosine oxidase (microoganism), Ascorbate oxidase (vegetal). Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP), Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide.
The provided text describes the ELITech Clinical Systems CREATININE PAP SL device, its calibrator (ELICAL 2), and controls (ELITROL I and ELITROL II). It details their intended use, composition, and performance characteristics, comparing them to predicate devices. The document essentially serves as a summary for a 510(k) premarket notification to the FDA, demonstrating substantial equivalence.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance data for the ELITech Clinical Systems CREATININE PAP SL and compares it directly to a predicate device (Roche Diagnostics Creatinine plus ver.2). The implication is that performance comparable to or better than the predicate device satisfies the acceptance criteria for substantial equivalence.
Here's a table summarizing the performance metrics and their comparison to the predicate device:
| Performance Characteristic | ELITech Clinical Systems CREATININE PAP SL (Reported Performance) | Predicate Device (Roche Diagnostics Creatinine plus ver.2) | Implied Acceptance Criteria (Demonstrates Substantial Equivalence) |
|---|---|---|---|
| Measuring Range | 0.28 - 22.30 mg/dL | 0.06 - 30.5 mg/dL | Range should cover clinically relevant levels and be comparable to predicate. (ELITech's range is narrower on both ends than the predicate). |
| Limit of Detection (LoD) | 0.006 mg/dL | Serum/plasma: 0.06 mg/dL | LoD should be sufficiently low for clinical utility and comparable to predicate. (ELITech's LoD is lower/better than the predicate for serum/plasma). |
| Limit of Quantification (LoQ) | 0.28 mg/dL | Not explicitly stated for LoQ, but LoD provides a lower bound. | LoQ should be clinically acceptable. (Compared to predicate's LoD, ELITech's LoQ is higher, but this is a different metric). |
| Precision (Within Run) | Level 0.59 mg/dL: CV=1.3% | ||
| Level 1.62 mg/dL: CV=0.8% | |||
| Level 6.93 mg/dL: CV=1.4% | Level 0.97 mg/dL: CV=2.29% | ||
| Level 3.95 mg/dL: CV=1.16% | |||
| Level 0.77 mg/dL: CV=2.86% | |||
| Level 12.7 mg/dL: CV=1.26% | Coefficient of Variation (CV) should indicate acceptable reproducibility and be comparable to predicate. (ELITech's within-run CVs generally appear better at comparable levels). | ||
| Precision (Total) | Level 0.59 mg/dL: CV=3.2% | ||
| Level 1.62 mg/dL: CV=1.6% | |||
| Level 6.93 mg/dL: CV=2.8% | Level 0.97 mg/dL: CV=2.35% | ||
| Level 3.95 mg/dL: CV=0.91% | |||
| Level 0.75 mg/dL: CV=1.87% | |||
| Level 13.2 mg/dL: CV=0.60% | CV should indicate acceptable reproducibility over time and be comparable to predicate. (ELITech's total CVs are mixed; some better, some worse than predicate at comparable levels). | ||
| Method Comparison (Regression) | y = 1.045x - 0.01 mg/dL | ||
| r = 0.999 | |||
| Range: 0.30 to 20.30 mg/dL | y = 1.006x - 0.013 mg/dL | ||
| r = 0.9998 | |||
| Range: 0.52 to 18.9 mg/dL | Regression analysis (slope, intercept, correlation coefficient) should demonstrate strong agreement with the predicate method. (Both devices show excellent correlation (r close to 1) and similar regression equations). | ||
| Interferences (Limitations) | Hemoglobin: No interference up to 500 mg/dL. | ||
| Triglycerides: No interference up to 3198 mg/dL. | |||
| Unconjugated bilirubin: No interference up to 30.0 mg/dL. | |||
| Conjugated bilirubin: No interference up to 14.8 mg/dL. | |||
| Uric acid: No interference up to 24 mg/dL. | |||
| Glucose: No interference up to 550 mg/dL. | |||
| Ascorbic acid: No interference up to 20 mg/dL. | |||
| Methyl-dopa, L-dopa, Calcium dobesilate: Falsely low results at therapeutic conc. | |||
| Creatine: Positive bias from 5 mg/dL. | Hemoglobin: No interference up to 800 mg/dL. | ||
| Lipemia (Intralipid): No influence up to L index of 1000. | |||
| Icterus: No influence up to I Index of 20 (20 mg/dL bilirubin). | |||
| Ascorbic acid: |
§ 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.