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Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.

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This is a 510(k) premarket notification for a Class I in vitro diagnostic device, not an AI/ML medical device. Therefore, the questions related to AI/ML device studies, such as acceptance criteria, sample sizes for test/training sets, expert involvement, and ground truth establishment, are not applicable.

The document indicates that the device, "Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer," has been determined to be substantially equivalent to legally marketed predicate devices. This means that the FDA has agreed that the device is as safe and effective as a device already on the market.

Here's a breakdown of the relevant information provided for this specific submission:

1. A table of acceptance criteria and the reported device performance:
   Not applicable in this document. Substantial equivalence for this type of device typically relies on demonstrating comparable performance to a predicate device, as opposed to meeting pre-defined acceptance criteria for novel AI/ML performance metrics.

2. Sample size used for the test set and the data provenance:
   Not applicable in this document. This submission does not detail a clinical study with a "test set" in the context of AI/ML validation data. Performance is likely demonstrated through analytical studies (e.g., accuracy, precision, linearity) comparing the device to a predicate, not through a prospective clinical study using a specified patient sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The concept of "ground truth" established by experts for a diagnostic algorithm is not relevant for this Class I lipoprotein test system.

4. Adjudication method for the test set:
   Not applicable.

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 an in vitro diagnostic assay, not an AI-powered diagnostic imaging or interpretation tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable.

7. The type of ground truth used:
   Not applicable. The performance of this device would be evaluated against established analytical methods and reference standards for HDL cholesterol measurement, not against an "expert consensus" or "pathology" ground truth as understood in AI/ML validation.

8. The sample size for the training set:
   Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of the K023784 Submission:

• Device Name: Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer
• Indication(s) For Use: To separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease.
• Regulatory Class: Class I
• Product Code: LBR (Lipoprotein test system)
• Decision: Substantial Equivalence to legally marketed predicate devices.
• Date: December 10, 2002

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