(276 days)
The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total ß-Human Chorionic Gonadotrophin methods on clinical chemistry systems.
This in vitro diagnostic device is intended for prescription use only.
Randox Maternal Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
The provided text describes the Randox Maternal Controls Levels 1, 2 and 3 device and its substantial equivalence to a predicate device, focusing on its intended use as quality control material.
However, the provided text does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical study would for a diagnostic device. Instead, it describes the product's characteristics and the basis for its 510(k) clearance, which is primarily demonstrating substantial equivalence to an already legally marketed predicate device.
The "acceptance criteria" for a control material typically relate to its stability and performance characteristics, but the document doesn't explicitly list numerical target values for these. The closest information related to this is the stability testing methodology.
Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability: Percentage deviation between stressed and routine control samples should be below 10% for a given shelf-life prediction. | "If a percentage deviation between stressed and routine is below 10% then a 1 year shelf life would be assigned to the control. For every week stressed at 37°C that passed these criteria then 1 year shelf life would be added. i.e. Controls stored for 3 weeks at 37°C which passed criteria would be given 3 years of shelf life." (This describes the methodology for determining stability-based shelf life, rather than reporting specific performance values for the Randox Maternal Controls). |
| Clinical Relevance of Analyte Concentrations: Analyte concentrations across the three levels are chosen to span a range including chemically significant or medical decision levels. | "The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories." |
Study Proving Device Meets Acceptance Criteria:
The provided document describes a stability study to determine the shelf-life of the controls. This is the primary "study" detailed in the submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Stability Test: Not explicitly stated in terms of number of individual control units tested. It refers to "a control stored at 37°C" and "the control stored at routine temperature," implying at least one sample was subjected to each condition.
- Data Provenance: Not specified, but the manufacturer is Randox Laboratories Limited, based in the United Kingdom. Given the context of a 510(k) submission, the data would have been generated as part of the device's development and testing by the manufacturer. It is a prospective study for the purpose of demonstrating stability characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated, but referred to as "a panel of experts."
- Qualifications of Experts: The document states they reviewed analyte concentrations "to ensure that the concentrations are clinically relevant." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided; however, based on the context of clinical chemistry controls, these would likely be clinical chemists, laboratory directors, or medical professionals with expertise in maternal serum screening.
4. Adjudication Method for the Test Set
- For the stability testing, the "adjudication method" is the comparison of percentage deviation against a 10% threshold. There's no human adjudication process described for the quantitative results of the stability test itself beyond this pre-defined criterion.
- For the clinical relevance of analyte concentrations, a "panel of experts" reviewed the concentrations, implying a consensus-based or expert opinion adjudication process, though the specific method (e.g., informal agreement, structured voting) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. This device is a quality control material for laboratory tests, not an imaging or interpretive diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable in the conventional sense. This device is a "control material," not an algorithm or an AI system. Its performance is evaluated biochemically/chemically, not through an algorithm's standalone interpretative capabilities. The "performance" relates to its stability and the accuracy of its assigned values for the analytes.
7. The Type of Ground Truth Used
- For Analyte Concentrations: Expert consensus/review regarding clinical relevance.
- For Stability: The "ground truth" for stability testing is the pre-defined target threshold of
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.