(63 days)
For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Reagent is used to quantitatively measure apolipoprotein A1 (ApoA1) concentration in human 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. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 21 is used to calibrate VITROS 5.1 FS Chemistry Systems for the quantitative measurement of apolipoprotein A 1 (ApoA1). For in vitro diagnostic use only. VITROS Chemistry Products ApoA1 Performance Verifier I is an assayed controls used to monitor the performance of ApoA1 Reagent on VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products ApoB Reagent is used to quantitatively measure apolipoprotein B (ApoB) concentration in human 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. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 22 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of apolipoprotein B (ApoB). For in vitro diagnostic use only. VITROS Chemistry Products ApoB Performance Verifier I is an assayed controls used to monitor the performance of ApoB Reagent on VITROS 5,1 FS Chemistry Systems.
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products ApoA1 Reagent and VITROS Chemistry Products Calibrator Kit 21, VITROS Chemistry Products ApoB Reagent and VITROS Chemistry Products Calibrator Kit 22, VITROS Chemistry Products ApoA1 Performance Verifier I and VITROS Chemistry Products ApoB Performance Verifier I ), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS ApoA1 and ApoB assays.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 1).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Here's a breakdown of the acceptance criteria and study information for the VITROS Chemistry Products ApoA1 and ApoB assays, Calibrator Kits, and Performance Verifiers, based on the provided text:
Acceptance Criteria and Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than defining explicit numerical acceptance criteria for novel performance claims. The key "acceptance criterion" for substantial equivalence is the demonstration of similar performance characteristics and intended use compared to the legally marketed predicate devices.
The study presented here is a correlation study comparing the new devices to the predicate devices.
Table of Acceptance Criteria and Reported Device Performance
| Device Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | VITROS ApoA1 Assay Performance | VITROS ApoB Assay Performance |
|---|---|---|---|
| Correlation | Correlation coefficient (r) with predicate device should be high, indicating agreement. | r = 0.987 (vs. Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent assay) | r = 0.985 (vs. Dade Behring N Antisera to Human Apolipoprotein B Reagent assay) |
| Linear Regression Formula (Slope & Intercept) | Linear relationship should be close to identity (slope ~1, intercept ~0) to predicate device. | VITROS ApoA1 = 0.98 X - 13.04 (mg/dL) | VITROS ApoB = 1.00 X - 3.88 (mg/dL) |
| Intended Use | Must be consistent with the predicate device. | For quantitative measurement of ApoA1 in human serum and plasma. Used in diagnosis and treatment of lipid disorders, atherosclerosis, and various liver/renal diseases. | For quantitative measurement of ApoB in human serum and plasma. Used in diagnosis and treatment of lipid disorders, atherosclerosis, and various liver/renal diseases. |
| Method | Immunoturbidimetric, matching predicate. | Immunoturbidimetric | Immunoturbidimetric |
| Reactive Ingredients | Similar reactive ingredients. | Goat antisera to human apolipoprotein A1 | Goat antisera to human apolipoprotein B |
| Instrumentation | Specified for VITROS 5,1 FS Chemistry System. | VITROS 5,1 FS Chemistry System | VITROS 5,1 FS Chemistry System |
| Reportable Range | Similar range to predicate, suitable for clinical use. | ApoA1: 30.00-240.00 mg/dL | ApoB: 35.00-300.00 mg/dL |
| Sample Type | Human Serum (and plasma for new devices). | Human Serum and Plasma | Human Serum and Plasma |
Note: The document also states that "studies were performed to determine the precision, specificity, linearity, antigen excess, lower limit of detection, and expected values of the VITROS ApoA1 and ApoB assays," with summaries in the Instructions for Use. However, the specific acceptance criteria and results for these additional studies are not provided in this summary document.
Study Details
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Sample Size used for the test set and the data provenance:
- The document states: "Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples."
- Specific sample size for the test set is NOT provided.
- Data Provenance: The origin (e.g., country) of the patient samples is NOT specified. The study appears to be retrospective in the sense that existing patient samples were used to perform the correlation with a legally marketed predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a predicate comparison study for an in vitro diagnostic (IVD) assay, not a study involving human expert interpretation of images or clinical data.
- No "experts" in the sense of clinicians or radiologists were used to establish ground truth. The "ground truth" for the test set is established by the results obtained from the predicate device's assay, which is itself a legally marketed and presumably validated quantitative test.
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Adjudication method for the test set:
- Not applicable. This study does not involve human interpretation or adjudication as it's a quantitative measurement device comparison.
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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:
- No. This is an IVD device, not an AI-assisted diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The study assessed the performance of the VITROS ApoA1 and ApoB assays as standalone quantitative measurement devices by comparing their results directly to those of the predicate assays. There is no human-in-the-loop component for the measurement itself, as it is an automated chemistry system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is established by the results obtained from the legally marketed predicate devices (Dade Behring N Antisera to Human Apolipoprotein A-1 Reagent assay and Dade Behring N Antisera to Human Apolipoprotein B Reagent assay) when measuring the same patient samples. This is a common approach for demonstrating substantial equivalence for new IVD assays.
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The sample size for the training set:
- Not applicable. This document describes a predicate comparison study for an IVD kit, which does not involve a "training set" in the context of machine learning or AI. The development of the assay itself would have involved internal validation and method optimization, but that is distinct from a "training set" for an algorithm.
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How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of this regulatory submission for an IVD assay.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.