(26 days)
The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
The modified device includes the connection of a StreamLAB® Analytical Workcell and Sample Transfer Module. These are used to prepare specimens from the human body for testing on the Dimension® RxL Max™ system.
This submission (K043546) is a Special 510(k) for a device modification; therefore, the provided document does not contain an acceptance criteria table or a detailed study report with performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device after a modification, rather than proving performance against specific acceptance criteria for a novel device.
The modification involves connecting a StreamLAB® Analytical Workcell and Sample Transfer Module to the existing Dimension® RxL Max™ Clinical Chemistry System. The core functionality and assay performance are stated to be "the same" as the predicate device.
However, based on the provided text, here's what can be extracted or inferred about the device and the nature of this submission:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. As a Special 510(k) for a device modification, the manufacturer primarily asserts that the modified device has "the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, explicit acceptance criteria and corresponding reported device performance for the modified components are not detailed, as the focus is on maintaining equivalence to the existing, cleared predicate.
2. Sample sized used for the test set and the data provenance
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given text.
4. Adjudication method for the test set
This information is not provided in the given text.
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
An MRMC study is not applicable to this device. This is a clinical chemistry analyzer, not a device requiring human reader interpretation of images or other subjective data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone clinical chemistry analyzer. The device itself performs the analysis; human interpretation is involved in reviewing the results it produces. However, the document does not describe "standalone performance" in the context of comparing an algorithm to human performance, as it's an automated analytical system.
7. The type of ground truth used
This information is not explicitly stated. For clinical chemistry analyzers, ground truth would typically be established through reference methods (e.g., gold standard laboratory tests) for accuracy and precision studies, but such studies are not described for this specific modification. The submission implies that the "assay performance characteristics" are the same as the predicate, which would have had its performance validated against appropriate ground truth.
8. The sample size for the training set
This information is not provided in the given text. Given that this is a modification to an existing device, it's unlikely that a new "training set" for an algorithm, as understood in AI/ML, would be applicable or explicitly mentioned in such a submission.
9. How the ground truth for the training set was established
This information is not provided in the given text.
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.