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510(k) Data Aggregation
(50 days)
The SYNCHRON® Systems DAT Multi-Drug Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene enzyme immunoassays.
The SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators are readyto-use human urine-based calibrator materials.
The provided document is a 510(k) summary for the SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study demonstrating the device meets those criteria in the way a performance study for an AI/ML medical device would.
This document pertains to a calibrator device, which is a reference material used to ensure the accuracy of other diagnostic tests. The performance evaluation for such a device focuses on its stability and its ability to function as intended for calibration, rather than on diagnostic accuracy metrics like sensitivity, specificity, or AUC which are common for AI/ML devices.
Therefore, many of the requested elements are not applicable to this type of device and the information provided in the 510(k) summary. I will answer as best as possible, indicating when information is not available or not applicable.
Description of Acceptance Criteria and Study Proving Device Meets Criteria
The SYNCHRON® Systems Multi-Drug DAT Low and High Urine Calibrators are ready-to-use human urine-based calibrator materials intended for use with SYNCHRON Systems and SYNCHRON Reagents to calibrate enzyme immunoassays for several drugs. The primary performance criteria for a calibrator are its stability and its ability to establish accurate points of reference for the assays. The study performed focused on stress stability to support the claimed shelf-life.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a calibrator device, explicit detailed "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity thresholds) are not typically defined in the same way as for a diagnostic test itself. Instead, the "acceptance criteria" for a calibrator revolve around its stability and its ability to consistently produce expected calibration values when used in conjunction with the assays it is designed for.
| Acceptance Criteria (Implied for Calibrators) | Reported Device Performance |
|---|---|
| Stability: Maintain intended chemical properties and concentration for a specified shelf-life. | Stress stability studies of the DAT Multi-Drug Low and High Urine Calibrators were conducted. These studies support the Beckman stability claim of 12 months. This indicates that the calibrators maintained their critical performance characteristics (e.g., concentration of target analytes) under accelerated or real-time conditions for at least 12 months. The specific measurements or thresholds for "maintenance" are not detailed in this summary, but would typically involve analytical precision and accuracy within defined limits. |
| Substantial Equivalence: Function comparably to a legally marketed predicate device. | The device was found to be "Identical to predicate product but labeled for Beckman Coulter, Inc." and was determined to be substantially equivalent to toxicology calibrators already in commercial distribution (Predicate: Multi-Drug Urine Calibrators from Diagnostic Reagents, Inc., K983159). This implies that its performance, when used as a calibrator, is expected to be comparable to that of the predicate. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: The document does not specify the sample size used for the stress stability studies. It only mentions "stress stability studies." For calibrators, this typically involves multiple lots of the calibrator material, subjected to various temperature and storage conditions over time.
- Data provenance: Not explicitly stated, but assumed to be generated internally by Beckman Coulter, Inc. as part of their product development and validation process. The country of origin for the data is implicitly the USA (company location). The studies are prospective in nature, as they assess stability over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a calibrator, "ground truth" is defined by the known concentrations of the analytes within the calibrator material, established through validated analytical methods, not by expert consensus or interpretation.
4. Adjudication method for the test set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which is not the case for calibrator stability studies.
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 device is a calibrator, not an AI/ML diagnostic tool, and involves no human reader interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a calibrator, not an algorithm or AI.
7. The type of ground truth used
The "ground truth" for a calibrator is the manufactured and verified concentration of each drug substance within the calibrator material. This is established through rigorous analytical testing during manufacturing and quality control.
8. The sample size for the training set
Not applicable. The concept of a "training set" is relevant for AI/ML models. For a calibrator, the manufacturing process and quality control define the product, not a training algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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