(20 days)
For in vitro diagnostic use only.
The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma.
VITROS Calibrator Kit 2
For in vitro diagnostic use only.
VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.
The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (modified) and VITROS Chemistry Products Calibrator Kit 2
The provided 510(k) summary describes a Special 510(k) submission for modifications to existing devices, specifically the VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides, and VITROS Chemistry Products Calibrator Kit 2. The focus of this submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish new comprehensive performance criteria from scratch.
Therefore, the information available is primarily a comparison against the existing, cleared predicate device rather than presenting entirely new acceptance criteria and a standalone validation study that would typically be detailed for a novel device.
Here's an analysis based on the available text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" for the modified device in terms of specific performance metrics (e.g., accuracy, precision targets). Instead, the demonstration of equivalence relies on showing that the modified device performs similarly to the predicate device across relevant characteristics and through comparative studies. The table presented focuses on the differences in device characteristics between the predicate and new device, rather than performance criteria.
However, the "Conclusions" section states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies that the de facto acceptance criteria were that the performance characteristics (e.g., accuracy, precision) of the modified device, when measured with patient and QC samples across the assay range, were within acceptable limits of the predicate device's established performance, demonstrating "substantial equivalence."
| Characteristic/Study Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantial equivalence to the predicate device (K984303) in terms of safety and effectiveness for quantitative measurement of HDL-Cholesterol in serum and plasma. | Demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range. |
| Assay Range | No change from predicate device. | 3.0- 100.0 mg/dL (No Change) |
| Intended Use | No change from predicate device. | For in vitro diagnostic use only. Quantitatively measure HDL-Cholesterol (HDLC) in serum and plasma. (No Change) |
| Basic Principle | No change from predicate device. | HDL separation by precipitation, magnetic removal of non-HDL lipoproteins, dry multilayered slide utilizing reflectance spectrophotometry. (No Change) |
| Sample Type | No change from predicate device. | Serum, Plasma (No Change) |
| Instrumentation | No change from predicate device. | VITROS 250, 550, 750 and 950 Series Analyzers (No Change) |
| Incubation time & temperature | No change from predicate device. | 5 minutes at 37°C (No Change) |
| Reactive Ingredients per CHOL slide (test) | Within acceptable manufacturing variation for modified quantities, ensuring equivalent performance to predicate. | Triton X-100 0.73 mg; cholesterol oxidase 0.36 U; cholesterol ester hydrolase 1.80 U; peroxidase 4.68 U; leuco dye 0.13 mg. (Reduced quantities from predicate) |
| Sample volume | Reduced volume with equivalent performance to predicate. | 5.5 µL (Reduced from 10 uL) |
2. Sample Size Used for the Test Set and Data Provenance
The summary states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range."
However, specific numerical sample sizes for the test set (number of patient samples, number of QC samples) are not reported in this 510(k) summary.
Data provenance (e.g., country of origin, retrospective/prospective) is not explicitly mentioned. Typically for IVDs, samples would be of human origin, and often from diverse populations to ensure generalizability, but this detail is absent. The study appears to be a laboratory validation study, likely prospective for the purpose of this submission if new lots were manufactured and tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is an in vitro diagnostic (IVD) device designed to quantitatively measure a biomarker (HDL-Cholesterol). The "ground truth" for such devices is established by reference methods or comparison to a legally marketed predicate device, as opposed to expert human interpretation of images or clinical assessments.
Therefore, the concept of "experts used to establish ground truth" in the way it applies to imaging AI (e.g., radiologists) is not applicable here. The ground truth would be the actual HDL-Cholesterol concentration as determined by a highly accurate or reference method, against which the device's measurements are compared. The expertise involved would be in clinical chemistry and laboratory professionals performing the reference measurements and statistical analysis.
4. Adjudication Method for the Test Set
As this is an IVD device measuring a quantitative biomarker, an "adjudication method" in the sense of reconciling disagreements between multiple human readers (as in imaging studies) is not applicable. The "adjudication" of results would involve standard laboratory quality control procedures, statistical analysis of agreement between the modified device and the predicate/reference method, and assessment against predefined analytical performance specifications. No specific method beyond general "demonstration of equivalence" is detailed in this summary.
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
This question is not applicable as this is an in vitro diagnostic (IVD) device for quantitative measurement of HDL-Cholesterol, not an AI-based imaging diagnostic device assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not entirely applicable in the AI sense. This device is a reagent and slide system that, when used with an analyzer (VITROS 250, 550, 750, and 950 Series Analyzers), quantitatively measures HDL-Cholesterol. The "standalone" performance is the device's ability to accurately measure the analyte. The study demonstrated the performance of the modified reagent/slides with the analyzer systems, demonstrating equivalence to the predicate. There isn't a separate "human-in-the-loop" component in the direct measurement process of this type of IVD, beyond a laboratory technician operating the instrument and interpreting the numerical output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this IVD device, the "ground truth" would implicitly be the measured HDL-Cholesterol values obtained from the predicate device (K984303) or potentially a recognized reference method, as indicated by the statement: "Equivalence was demonstrated... along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies a comparison against established, presumably accurate, values.
8. The Sample Size for the Training Set
This type of device (reagents and slides for chemical measurement) does not typically involve a "training set" in the machine learning/AI sense. Its performance is based on the chemical reactions and optical measurement principles. The development and optimization of the reagent formulation might involve experimental testing, but it's not a "training set" for an algorithm. Therefore, this information is not provided.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense for this IVD device, this question is not applicable.
§ 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.