(56 days)
For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acctaminophen overdose.
The Roche Acetaminophen assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche Acetaminophen reagent kits.
Here's an analysis of the provided text regarding the Roche Acetaminophen Assay, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the Roche Acetaminophen Assay. However, it does present performance characteristics for comparison to the predicate device. For the purpose of this response, I will infer the acceptance criteria are implicitly defined by the acceptable performance compared to the predicate and the general requirements for such assays (e.g., adequate precision and method correlation).
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Roche Acetaminophen Performance |
|---|---|---|
| Precision | CV% comparable to or better than predicate device. | Level 1: Total CV% = 5.7% (Predicate Level 1: 7.5%) |
| Level 2: Total CV% = 1.4% (Predicate Level 2: 4.4%) | ||
| Level 3: Total CV% = 4.9% (Predicate Level 3: 4.9%) | ||
| Method Comparison | Good correlation (R value) with predicate device. Slope and intercept indicating substantial equivalence. | Y = -0.31 + 0.987x (vs. Roche COBAS INTEGRA Acetaminophen) |
| R = 0.999 (vs. Roche COBAS INTEGRA Acetaminophen) | ||
| Range = 1.2 to 160.6 ug/mL | ||
| Lower Detection Limit | Acceptable for clinical use of toxic levels. | Not explicitly stated for the device itself, but the range of method comparison starts at 1.2 ug/mL. |
| Specificity | Not explicitly detailed in the summary. | "All of the evaluation studies gave acceptable results compared to the predicate device." |
| Interfering Substances | Not explicitly detailed in the summary. | "All of the evaluation studies gave acceptable results compared to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For comparison against the Roche COBAS INTEGRA Acetaminophen assay on the COBAS Integra 700: N = 150
- For comparison of the predicate device (Roche COBAS INTEGRA Acetaminophen) against the Abbott TDx Acetaminophen assay: N = 87 (This refers to data for the predicate, not the new device's primary test set)
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device. The Roche Acetaminophen Assay is an in vitro diagnostic (IVD) quantitative assay. Its "truth" is established by comparing its measurements to a reference method (the predicate device) or a gold standard method, not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this IVD assay. The comparison is based on quantitative analytical results.
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
This is not applicable. The Roche Acetaminophen Assay is an IVD device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or classification tool that would involve human "readers."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance of the Roche Acetaminophen Assay, as described, is inherently a "standalone" performance in the context of an IVD. It generates a quantitative result without human intervention in the analytical process. The study described (method comparison) assesses this standalone analytical performance against a known method.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was established by comparing the results of the new Roche Acetaminophen Assay against a predicate device (Roche COBAS INTEGRA Acetaminophen Assay), which is itself an already validated and legally marketed device. In essence, the predicate serves as the reference method or "gold standard" for this comparative study.
8. The Sample Size for the Training Set
This information is not provided as there is no mention of a "training set" in the context of this chemical assay. Chemical assays are developed and validated through analytical studies, not typically machine learning training protocols.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set described for this type of device.
§ 862.3030 Acetaminophen test system.
(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.