(144 days)
Diazyme Liquid Enzymatic Assay Kit is for quantitative in vitro determination of Lithium in human serum. Measurements of Lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
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The provided text (from {0} to {2}) is a 510(k) clearance letter from the FDA for a medical device called "Diazyme Liquid Stable Enzymatic Lithium Assay." This document primarily focuses on regulatory approval and equivalence to a predicate device. It does not contain specific information regarding acceptance criteria, study details, or performance metrics in the format requested.
Therefore, most of the information required to populate the table and answer the detailed questions is not present in the provided text. The document is a clearance letter, not a study report or clinical trial summary.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | Not specified in this document |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- Not specified. This type of study is more common for imaging devices or AI-assisted diagnostics, not a liquid assay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is an "Enzymatic Lithium Assay," which is a lab test, not an algorithm in the typical sense of AI/ML. The concept of "standalone performance" as it applies to AI without human-in-the-loop is not relevant here. The device itself performs the assay.
7. The type of ground truth used:
- For an assay device, the "ground truth" would typically refer to a reference method or validated comparative method against which the new assay's measurements are compared. This is not specified in the document.
8. The sample size for the training set:
- Not specified. (Note: For a traditional lab assay, "training set" is not a standard term like it is for AI/ML. There would be R&D and validation work, but the concept of a "training set" for an algorithm isn't directly applicable.)
9. How the ground truth for the training set was established:
- Not specified. (As above, "training set" concept is not directly applicable.)
In summary, the provided FDA clearance letter indicates the device's regulatory pathway and its "substantially equivalent" status to a predicate device, but it does not detail the technical performance studies and their specific methodologies.
§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.