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510(k) Data Aggregation
(252 days)
The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
sCal: For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
Nortrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Abtrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
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This document describes the regulatory submission for a diagnostic device, not an AI/ML powered device. As such, concepts like "AI vs without AI assistance," "standalone performance," or "training set" are not applicable. The information provided focuses on the analytical performance of the Creatinine (Enzymatic) assay and its substantial equivalence to a predicate device.
Here's an analysis of the provided text based on the request, reinterpreting some terms for a diagnostic assay where appropriate:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "CV must be <= X%"). Instead, the performance is demonstrated through comparison with a predicate device and presentation of precision and method comparison data. The implied acceptance criterion for these studies is "comparable to the predicate device" or "within acceptable analytical variability."
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Creatinine Enzymatic) | Predicate Device Performance (COBAS Integra Creatinine plus ver.2) |
|---|---|---|---|
| Precision - Serum/Plasma (Within Run CV%) | Comparable to predicate / Low CV% | Level 0.43 mg/dL: 1.5%Level 1.75 mg/dL: 0.4%Level 5.47 mg/dL: 0.4% | Level 1.0 mg/dL: 1.6%Level 3.7 mg/dL: 0.7% |
| Precision - Serum/Plasma (Between Run CV%) | Comparable to predicate / Low CV% | Level 0.43 mg/dL: 0.4%Level 1.75 mg/dL: 0.5%Level 5.47 mg/dL: 0.3% | Level 1.0 mg/dL: 1.3%Level 3.8 mg/dL: 0.9% |
| Precision - Serum/Plasma (Total CV%) | Comparable to predicate / Low CV% | Level 0.43 mg/dL: 2.2%Level 1.75 mg/dL: 1.5%Level 5.47 mg/dL: 1.4% | (Not explicitly stated for total for predicate, but similar magnitude) |
| Precision - Urine (Within Run CV%) | Comparable to predicate / Low CV% | Level 76 mg/dL: 1.0%Level 90 mg/dL: 0.8%Level 165 mg/dL: 0.9%Level 251 mg/dL: 0.9% | Level 106 mg/dL: 0.8%Level 231 mg/dL: 1.8% |
| Precision - Urine (Between Run CV%) | Comparable to predicate / Low CV% | Level 76 mg/dL: 0.8%Level 90 mg/dL: 0.5%Level 165 mg/dL: 1.2%Level 251 mg/dL: 0.9% | Level 108 mg/dL: 2.0%Level 238 mg/dL: 3.9% |
| Precision - Urine (Total CV%) | Comparable to predicate / Low CV% | Level 76 mg/dL: 3.5%Level 90 mg/dL: 3.1%Level 165 mg/dL: 3.5%Level 251 mg/dL: 3.5% | (Not explicitly stated for total for predicate, but similar magnitude) |
| Method Comparison - Serum (Correlation/Slope/Intercept) | Strong correlation (R/r close to 1), slope close to 1, intercept close to 0. | y = 1.01x - 0.001 (R = 1.000, N=41) | y = 1.01x + 1.13 µmol/l (r = 0.999, n=53) |
| Method Comparison - Plasma (Correlation/Slope/Intercept) | Strong correlation (R/r close to 1), slope close to 1, intercept close to 0. | Deming: y = 0.97 - 0.02 (r = 1.000, N=52) | (Predicate does not provide separate plasma comparison data, only serum/plasma combined) |
| Method Comparison - Urine (Correlation/Slope/Intercept) | Strong correlation (R/r close to 1), slope close to 1, intercept close to 0. | y = 1.03x + 1.34 (R = 0.999, N=135) | y = 0.94x + 0.63 mmol/l (r = 0.998, n=54) |
| Measurement Range - Serum/Plasma | Comparable to predicate | 0.11 – 28 mg/dL | 0 – 30.5 mg/dL |
| Measurement Range - Urine | Comparable to predicate | 2.3 – 452 mg/dL | 0 – 452 mg/dL |
| Interference - Lipemia | No significant interference up to stated level. | No interference found up to 1000 mg/dL (10 g/l) of Intralipid. | No significant interference up to 1000 mg/dL (triglycerides/Intralipid). |
| Interference - Hemolysate | No significant interference up to stated level. | Serum: No interference found up to 1000 mg/dL (10 g/l) hemoglobin.Urine: No interference found up to 1000 mg/dL (10 g/l) hemoglobin. | Serum: No significant interference up to 0.50 mmol/L (8 g/l) hemoglobin. |
| Interference - Bilirubin (conjugated & unconjugated) | No significant interference up to stated level. | Conjugated: Serum up to 17 mg/dL, Urine up to 58 mg/dL.Unconjugated: Serum up to 23 mg/dL. | No significant interference up to 340 µmol/l (20 mg/dL). |
| Interference - Ascorbic Acid | No significant interference up to stated level. | Serum: No interference found up to 1.70 mmol/L (30 mg/dL).Urine: No interference found up to 100 mg/dL (5.7 mmol/l). | No significant interference up to 1.70 mmol/L (30 mg/dL). |
| Interference - Creatine | No significant interference up to stated level. | No interference found up to 1.53 mmol/L (20 mg/dL). | No significant interference up to 1.53 mmol/L (20 mg/dL). |
2. Sample Sizes used for the Test Set and the Data Provenance
- Precision Studies: The document provides various "levels" (concentrations) for serum/plasma and urine. Each level typically has multiple measurements to calculate SD and CV. The exact number of individual samples/patients for precision studies is not explicitly stated, but it's common practice to use control materials or pooled patient samples across multiple runs.
- Method Comparison Studies:
- Serum: N = 41 samples
- Plasma: N = 52 samples
- Urine: N = 135 samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given it's a submission by "Thermo Fisher Scientific Oy" from "Vantaa, Finland," it's highly probable the studies were conducted in Finland or at least led by the Finnish branch. Standard analytical validation studies are typically prospective tests on collected samples.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts
This is an analytical device for measuring creatinine concentration, not an imaging or diagnostic AI device that requires expert interpretation. The "ground truth" for the test set is established by:
- Reference Methods: The predicate device (Roche/Hitachi 917 analyzer) is used as the comparative "reference" in the method comparison studies.
- Traceability/Standardization: The device's calibration is traceable to NIST SRM 967 (for serum) and NIST SRM 914a (for urine), which are primary reference materials.
- Known Concentrations: For precision studies, control materials or spiked samples with known creatinine concentrations are used.
Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation is not relevant here. The ground truth is analytical and based on established reference methods and standards.
4. Adjudication method for the test set
Not applicable for an analytical assay. Adjudication is typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies.
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 an in-vitro diagnostic (IVD) assay, not an AI or imaging device with human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (precision, method comparison, measuring range, limitations) represents the standalone performance of the CREATININE (Enzymatic) assay system (reagent + T60 instrument). There is no "human-in-the-loop" performance component beyond sample handling and instrument operation, which is standard for IVD assays.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on:
- Reference Measurement Procedures: Comparison against a legally marketed predicate device (Roche/Hitachi 917 analyzer) which itself has established accuracy.
- Reference Materials: Traceability to NIST (National Institute of Standards and Technology) Standard Reference Materials (SRM 967 for serum, SRM 914a for urine), which provide certified concentrations.
- Known Spiked Concentrations: For certain studies like interference testing, known concentrations of interfering substances are added.
Essentially, the ground truth is analytical accuracy and precision relative to established standards and methods.
8. The sample size for the training set
Not applicable in the context of this traditional IVD assay. There is no "training set" for an algorithm. The assay is a chemical reaction measured by an instrument.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm. The "ground truth" (analytical accuracy) for the device's development would have been established through rigorous chemical and analytical procedures, calibration with reference materials, and verification against known samples during product development.
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