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510(k) Data Aggregation
(131 days)
Atellica CH Enzymatic Creatinine_3 (ECre3)
The Atellica® CH Enzymatic Creatinine 3 (ECre3) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin and dipotassium EDTA), and urine using the Atellica® CH Analyzer. Such measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
The Atellica CH ECre3 assay measures the concentration of creatinine through a series of coupled enzymatic reactions and is based upon the method developed by Masaru and Mitsutaka. The Atellica CH ECre3 assay uses a series of coupled enzymatic reactions. In a "pretreatment" reaction, endogenous creatine and sarcosine are removed from a test sample by creatinase and sarcosine oxidase. The level of creatinine in a test sample is then determined through coupled enzymatic reactions. First, creatinine is enzymatically converted by creatininase into creatine. Creatine is then enzymatically converted to sarcosine by creatinase. This is followed by the oxidation of sarcosine by sarcosine oxidase to produce hydrogen peroxide. In the presence of peroxidase, the hydrogen peroxide allows for the oxidative condensation of 4-aminoantipyrine and N-ethyl-N-(3-methylphenyl)-N'-succinyl-ethylenediamine to produce a reddish purple quinone pigment. The absorbance of this quinone pigment is measured as an endpoint reaction at 545/694 nm.
This document describes the performance of the Atellica® CH Enzymatic Creatinine 3 (ECre3) assay, a new in vitro diagnostic device for quantitative determination of creatinine. The information provided is for a 510(k) Premarket Notification to the FDA, demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" here refers to the performance thresholds that the new device must meet to show it functions as intended and is comparable to the predicate device. The "study" refers to the analytical performance validation studies conducted.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Sizes and Data Provenance
Since this is an in vitro diagnostic (IVD) device, the "acceptance criteria" are typically defined as performance specifications that demonstrate the device's analytical accuracy, precision, linearity, and freedom from interferences. These are not clinical acceptance criteria in the sense of diagnostic accuracy to a specific disease state, but rather analytical performance metrics. The document compares the new device (candidate) to a predicate device and established standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Target/Goal) | Reported Device Performance (Achieved) | Sample Size for Test Set (and Provenance) |
|---|---|---|---|
| Detection Capability | LoQ: ≤ 0.15 mg/dL (serum/plasma), ≤ 2.00 mg/dL (urine) - (Lowest concentration at which total analytical error is ≤ 0.10 mg/dL for serum/plasma and ≤ 1.50 mg/dL for urine) | LoB: Serum/plasma: 0.05 mg/dL; Urine: 0.15 mg/dL | |
| LoD: Serum/plasma: 0.10 mg/dL; Urine: 0.50 mg/dL | |||
| LoQ: Serum/plasma: 0.15 mg/dL; Urine: 2.00 mg/dL | |||
| (Meets or exceeds design specifications for LoQ) | Not explicitly stated as a "sample size" for detection capability tests in terms of unique patient samples, but the methodology (CLSI Document EP17-A2) typically involves repeated measurements of blank, low-concentration, and spiked samples. Provenance is not specified for these control samples or blanks. | ||
| Precision | Not explicitly stated as a single numerical acceptance criterion (e.g., CV X), but expected to demonstrate strong correlation between plasma types and serum. Evaluated against CLSI EP09c. | Lithium heparin plasma vs. Serum: y = 0.99x + 0.00 mg/dL; r = 1.000 | |
| Dipotassium EDTA plasma vs. Serum: y = 0.97x + 0.02 mg/dL; r = 0.998 | |||
| (Demonstrates strong equivalency) | For each comparison (Lithium heparin plasma vs. Serum, Dipotassium EDTA plasma vs. Serum): 55 samples. Provenance of these patient samples is not specified. Implied human patient samples. | ||
| Interferences (HIL) | ≤ 10% bias from hemoglobin, bilirubin, and lipemia. Bias > 10% is considered interference. | Hemoglobin: -3.2% to 6.0% (at tested concentrations) | |
| Bilirubin (conjugated & unconjugated): -1.6% to -6.2% (at tested concentrations) | |||
| Lipemia (Intralipid®): -2.6% to -3.8% (at tested concentrations) | |||
| (All tested HIL substances show ≤ 10% bias, meeting the criterion) | Not explicitly stated as "sample size" for this study. Interference testing typically involves preparing samples with known analyte concentrations and varying concentrations of interferents. Provenance of samples is not specified, likely control or pooled samples spiked with interferents. | ||
| Non-Interfering Substances | ≤ 10% bias at specific analyte concentrations (1.00 mg/dL and 8.00 mg/dL for serum; 40.00 mg/dL and 180.00 mg/dL for urine). | Various common substances (e.g., Acetaminophen, Cefoxitin, Glucose) tested showed biases generally well within the ±10% range. Phenindione is an exception, with a warning against its use due to reported falsely depressed results. | |
| (Generally meets criteria, with a clinically relevant exception noted) | Not explicitly stated as "sample size". Similar to HIL, involves preparation of spiked samples. Provenance of samples is not specified. | ||
| Linearity | Demonstrate linearity for the measuring interval from 0.15-30.00 mg/dL (serum/plasma) and 2.00–245.00 mg/dL (urine). | Achieved: Linear from 0.15-30.00 mg/dL for Serum/plasma and from 2.00–245.00 mg/dL for Urine. | |
| (Meets the specified measuring interval) | Not explicitly stated as "sample size". Linearity studies (CLSI EP06-A) typically involve preparing and testing several dilutions of high-concentration samples. Provenance is not specified. |
Data Provenance (General): The document does not explicitly state the country of origin for the patient samples used in method comparison or specimen equivalency studies. It also does not specify if the studies were retrospective or prospective, though for IVD analytical performance, they are typically prospective analytical studies using characterized samples (pooled, spiked, or real patient samples collected for the study).
Regarding items 3-9 for this IVD document:
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For an IVD device like this, "ground truth" for analytical performance studies is established by reference methods (e.g., Isotope Dilution Mass Spectrometry - IDMS, as seen in the assay comparison) or against a legally marketed predicate device (ADVIA Chemistry ECRE_2 assay). It is not established by human experts (like radiologists reading images) for diagnostic accuracy or consensus in the typical sense for medical imaging or clinical decision support AI. The "experts" would be the metrologists or lab professionals validating the reference methods according to CLSI guidelines.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of an IVD analytical performance study. Adjudication methods are relevant for subjective interpretations, like radiology image reads or pathological diagnoses, where human variability exists and a consensus "ground truth" needs to be established. Here, the "truth" is quantitative measurement by reference methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. MRMC studies are used to assess the comparative effectiveness of different diagnostic methods (often involving human readers and AI) where subjectivity and reader variability are factors. This submission is for an in vitro diagnostic assay, which provides quantitative values, not an imaging-based AI or a system that aids human interpretation in a subjective setting.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is inherently a "standalone" device in the sense that it is an automated laboratory assay. Its performance is measured directly (algorithm only) against reference methods or the predicate, as presented in the analytical performance section. There isn't a "human-in-the-loop" component in its operation or interpretation beyond the lab professional running the analyzer and reviewing results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance evaluation is established by:
- Reference Methods: Specifically, Isotope Dilution Mass Spectrometry (IDMS) for creatinine measurements, which is a highly accurate and precise chromatographic-mass spectrometric method. This is considered the "gold standard" for creatinine measurement.
- Comparison to a Legally Marketed Predicate Device: The ADVIA® Chemistry Enzymatic Creatinine_2 (ECRE_2) assay. The performance against the predicate is used to demonstrate "substantial equivalence."
- Internal analytical validation: Using controlled samples (e.g., spiked samples, control materials) for precision, linearity, interference studies, where the "ground truth" is the known concentration or expected behavior of the sample.
8. The sample size for the training set:
- This document describes the validation of the device's performance, not its development or "training." For an IVD assay (like a chemical reagent and analyzer system), there isn't a "training set" in the machine learning sense. The assay is based on established enzymatic reaction principles, not on learned patterns from a "training set" of data. Therefore, this concept is not applicable here.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of IVD device. The assay's chemical reactions and measurement principles are intrinsically defined, not learned from data.
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