(62 days)
Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers.
LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
Not Found
This document is a 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically an "LDL Cholesterol (Automated) Reagent." The letter indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness.
Here's a breakdown based on the provided text, highlighting what's not present:
Missing Information: The core request for acceptance criteria and a study demonstrating performance is not addressed in this regulatory clearance letter. This type of letter acknowledges substantial equivalence but does not delve into the specifics of performance studies.
Despite the limitations, I will attempt to answer each point, noting when the information is unavailable in the provided text.
Acceptance Criteria and Device Performance Study Information
This 510(k) clearance letter does not provide the acceptance criteria or detailed results of a performance study for the LDL Cholesterol (Automated) Reagent. The letter is a regulatory document indicating substantial equivalence to a legally marketed predicate device, rather than a technical report on the device's performance characteristics.
Therefore, the following table and subsequent sections will largely indicate "Not provided in the text" for the requested details.
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not Specified in Document | Not provided in the text | Not provided in the text |
| (e.g., Accuracy, Precision, Linearity, Interference, Method Comparison with Reference Method) | Not provided in the text | Not provided in the text |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not provided in the text.
- Data Provenance: Not provided in the text (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided in the text. For IVD devices like a cholesterol reagent, ground truth is typically established by reference methods or validated laboratory measurements, not by expert interpretation in the same way as imaging or pathological diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided in the text. Adjudication methods are typically used in studies involving human interpretation (e.g., imaging, clinical diagnoses) rather than quantitative laboratory assays.
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 automated reagent for quantitative determination of LDL Cholesterol, not an AI-assisted diagnostic imaging or interpretative tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device described, "LDL Cholesterol (Automated) Reagent," is inherently a standalone (algorithm/reagent only) system for quantitative measurement. The concept of "human-in-the-loop" assistance, as typically applied to AI, does not directly apply here. The performance of the reagent is evaluated on its ability to accurately measure LDL cholesterol without human interpretation affecting the result generation itself. However, the specific study details confirming this standalone performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in the provided text. For an LDL Cholesterol assay, the ground truth would typically be established by a recognized reference method (e.g., CDC reference method for cholesterol, ultracentrifugation, or isotope dilution-mass spectrometry) or by a highly validated predicate device.
8. The sample size for the training set
- Not applicable/Not provided in the text. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the conventional sense. Performance is evaluated through analytical and clinical validation studies using patient samples.
9. How the ground truth for the training set was established
- Not applicable/Not provided in the text, as this is not an AI/ML device with a "training set."
Summary of Document Content:
The provided document is an FDA 510(k) clearance letter for the JAL Diagnostics, Inc. LDL Cholesterol (Automated) Reagent. Key information from the letter includes:
- Device Name: LDL Cholesterol (Automated) Reagent
- Indications for Use: Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers. Used in the diagnosis and treatment of disorders involving high LDL Cholesterol, associated with increased risk of coronary heart disease.
- Regulatory Status: Class I device, Product Code: MRR; JHM; JIX; JJY. Found substantially equivalent to a legally marketed predicate device.
- Clearance Date: September 30, 2002.
Conclusion:
This 510(k) clearance letter confirms that the FDA found the device "substantially equivalent" to existing predicate devices, allowing it to be marketed. However, it does not include the detailed technical data, performance acceptance criteria, or specific study results that would typically be contained within a device's 510(k) submission summary or a separate performance study report. This kind of detail is usually found in the original 510(k) submission, which is not provided here.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.