(58 days)
For in vitro diagnostic use only. VITROS Chemistry Products IgG Reagent is used to quantitatively measure immunoglobulin G (IgG) concentration in human serum and plasma.
For in vitro diagnostic use only. VITROS Chemistry Products IgA Reagent is used to quantitatively measure immunoglobulin A (IgA) concentration in human serum and plasma.
For in vitro diagnostic use only. VITROS Chemistry Products IgM Reagent is used to quantitatively measure immunoglobulin M (IgM) concentration in human serum and plasma.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgG, IgA and IgM.
For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers I, II, and III are assayed controls used to monitor the performance of TRFRN, C3, C4, IgG, IgA and IgM Reagents 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 Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products IgG, IgA, and IgM Reagents and VITROS Chemistry Products Calibrator Kit 20, and VITROS Chemistry Products Protein Performance Verifiers I, II, and III), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS IgG, IgA, and IgM assays.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports.
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 (BSA/ Saline).
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 IgG, IgA, and IgM Reagents, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are primarily demonstrated through method comparison studies, exhibiting strong correlation and linear relationships with a legally marketed predicate device. The performance metrics focus on accuracy and analytical characteristics rather than diagnostic outcome metrics (like sensitivity/specificity for a particular disease).
| Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (VITROS IgG, IgA, IgM assays) |
|---|---|---|
| Method Comparison (Correlation) | High correlation to predicate device (implied r ≥ 0.97, given the presented values) | IgG: r = 0.995 |
| IgA: r = 0.999 | ||
| IgM: r = 0.998 | ||
| Method Comparison (Slope) | Slope near 1 (implied, indicating proportional agreement) | IgG: 0.98 |
| IgA: 1.07 | ||
| IgM: 1.02 | ||
| Method Comparison (Intercept) | Intercept near 0 (implied, indicating constant agreement) | IgG: 91.2 mg/dL |
| IgA: -3.03 mg/dL | ||
| IgM: 1.1 mg/dL | ||
| Intended Use | Same as predicate (quantitative measurement of immunoglobulins in human serum/plasma). | Same as predicate. |
| Method | Same as predicate (Immunoturbidimetric). | Same as predicate. |
| Reportable Range (IgG) | Similar to predicate (e.g., within a clinically acceptable range). | 270 - 2700 mg/dL (Predicate: 140 - 4600 mg/dL) |
| Reportable Range (IgA) | Similar to predicate. | 40 - 800 mg/dL (Predicate: 25 - 800 mg/dL) |
| Reportable Range (IgM) | Similar to predicate. | 25 - 400 mg/dL (Predicate: 20 - 640 mg/dL) |
| Sample Type | Same as predicate (Human Serum). | Same as predicate. |
| Reactive Ingredients | Similar (e.g., Goat vs. Rabbit antisera to human immunoglobulins). | Goat antisera to human IgG, IgA, IgM (Predicate: Rabbit antisera) |
| Instrumentation | Compatible with the overall VITROS 5,1 FS Chemistry System. | VITROS 5,1 FS Chemistry System (Predicate: DADE BN ProSpec) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples." However, it does not specify the sample size of these patient samples used in the method comparison studies.
The document also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies performed are analytical performance studies comparing the new device to a predicate device, not diagnostic performance studies requiring ground truth established by experts. The "ground truth" in this context is the measurement obtained from the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. The studies are method comparison assays against a predicate device, not studies that would require expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for imaging or diagnostic tools where human interpretation plays a significant role in the outcome. The devices described are automated in vitro diagnostic assays for quantitative measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The studies described are inherently standalone (algorithm only) in nature. The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer, and the reagents are designed for automated use. The performance characteristics of the assay itself are being evaluated, without human interpretation of raw data.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies (method comparison) was the measurements obtained from the legally marketed predicate devices:
- Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay
- Dade Behring N Protein Standard SL (human)
For other analytical studies like precision, specificity, linearity, antigen excess, lower limit of detection, and expected values, the ground truth would be established through appropriate reference materials, calibrators, and experimental design according to recognized laboratory standards, though specific details are not provided in this summary.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided in the document. These are in vitro diagnostic reagents and an automated chemistry system that perform quantitative measurements based on well-established immunoturbidimetric principles. There is no "training set" in the context of machine learning algorithms for image analysis or other similarly complex data interpretation tasks. The development of such systems involves assay optimization and validation rather than algorithm training on a distinct dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as point 8.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).