(62 days)
The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Creatinine is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma, or urine. The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, 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 amount of creatinine in the sample.
Here's an analysis of the provided 510(k) summary, broken down to address your specific questions about acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance for Crea Creatinine Assay
This 510(k) summary details the substantial equivalence of the Abbott Laboratories Crea Creatinine assay to the Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer. The acceptance criteria are implicitly defined by achieving "acceptable correlation" and "similar performance characteristics" compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit - based on predicate) | Reported Device Performance (Crea Creatinine Assay) |
|---|---|---|
| Method Comparison (Serum) | Acceptable correlation with predicate | Correlation coefficient = 0.9997, slope = 0.873, Y-intercept = 0.078 mg/dL (vs. Boehringer Mannheim Creatinine assay on Hitachi 717) |
| Method Comparison (Urine) | Acceptable correlation with predicate | Correlation coefficient = 0.9947, slope = 1.056, Y-intercept = -2.410 mg/dL (vs. Boehringer Mannheim Creatinine assay on Hitachi 717) |
| Precision (Serum - Level 1) | Acceptable precision | Total %CV for Level 1/Panel 101 is 3.0% |
| Precision (Serum - Level 2) | Acceptable precision | Total %CV for Level 2/Panel 102 is 2.6% |
| Precision (Urine - Level 1) | Acceptable precision | Total %CV for Level 1/Panel 201 is 1.6% |
| Precision (Urine - Level 2) | Acceptable precision | Total %CV for Level 2/Panel 202 is 2.1% |
| Linearity (Serum) | Acceptable linearity up to a certain concentration | Linear up to 38.7 mg/dL |
| Linearity (Urine) | Acceptable linearity up to a certain concentration | Linear up to 757.0 mg/dL |
| Limit of Quantitation (Sensitivity) | Acceptable sensitivity | 0.10 mg/dL |
| Assay Range | Similar to predicate, minor difference acceptable | Minor difference between assay range compared to Boehringer Mannheim |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the comparative performance studies (method comparison, precision, linearity, sensitivity).
The data provenance is not explicitly stated in terms of country of origin. The studies were conducted internally by Abbott Laboratories ("Comparative performance studies were conducted using the AEROSET™ System"). The studies appear to be prospective, as they involve testing the new Crea assay and comparing its performance against a legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of in vitro diagnostic device (IVD) submission. The "ground truth" for a quantitative chemical assay like creatinine is established by the reference method (the predicate device in this case) and traceable standards, not by expert consensus or interpretation of images. The performance is measured against objective chemical measurements.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative IVD device. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging studies where human interpretation is involved to establish ground truth or resolve discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation of medical images or data, not for automated quantitative chemical assays.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, this study is inherently a standalone performance study. The Crea Creatinine assay is an automated in vitro diagnostic assay. Its performance characteristics (correlation, precision, linearity, sensitivity) are measured directly from the device's output, without human intervention in the result generation process itself. The comparison is against another automated device (the predicate).
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the legally marketed predicate device, the Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer, as well as established analytical standards for linearity and sensitivity. The goal is to demonstrate "substantial equivalence" to this predicate, meaning the new device performs similarly.
8. The Sample Size for the Training Set
This information is not provided and is generally not applicable in the same way it would be for AI/ML-based devices. For an IVD like this, "training" typically refers to the development and optimization process, not a distinct dataset used for machine learning. The studies described are validation (test set) studies.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" with ground truth in the AI/ML sense doesn't directly apply here. The device was likely developed and optimized through standard chemical and engineering principles to accurately measure creatinine, with its performance then validated against the predicate device and analytical 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.