Search Results
Found 1 results
510(k) Data Aggregation
(19 days)
Vitros Chemistry Products CRP Slides For in vitro diagnostic use only. Vitros Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. Vitros Chemistry Products Calibrator Kit 7 For in vitro diagnostic use only. Vitros Calibrator Kit 7 is intended for use in the calibration of the Vitros Chemistry Systems for the quantitative measurement of CRP.
The Vitros Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multilayered analytical element of a Vitros slide. The system is comprised of two main elements: 1. The range of Vitros Chemistry Products (in this case Vitros Chemistry Products CRP Slides and Vitros Chemistry Products Calibrator Kit 7), which are combined on the Vitros Chemistry System to perform the Vitros CRP assay. 2. The Vitros Chemistry System - instrumentation, which provides automated use of the chemistry slides. Vitros 250 and 950 Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K922072 and K946090, respectively). The Vitros Chemistry System and Calibrators are dedicated specifically for use only with the Vitros Chemistry Products range of products. The Vitros System uses common reagents. The Vitros Chemistry Products Specialty Diluent and Vitros ImmunoWash fluid were cleared by previous 510(k) pre-market notification (K962235 and K942610, respectively).
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the VITROS Chemistry Products CRP Slides:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it demonstrates substantial equivalence to a predicate device. The performance is assessed by comparing key characteristics and showing that the modified device performs similarly or equivalently.
| Device Characteristic | Predicate Device (Current Vitros CRP Slide) | New Device (Modified Vitros CRP Slide) | Equivalence/Performance |
|---|---|---|---|
| Sample Volume | 11 µL | No Change (Implies 11 µL) | Equivalent |
| Wash Volume | 12 µL | No Change (Implies 12 µL) | Equivalent |
| Intended Use | For in vitro diagnostic use only. Vitros CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. | No Change (Same intended use) | Equivalent |
| Basic Principle | Dry multi-layered slide utilizing reflectance spectrophotometry. | No Change (Same basic principle) | Equivalent |
| Sample Type | Serum, Plasma (lithium heparin, sodium citrate and EDTA) | Serum, Plasma (heparin and EDTA) | Similar, with a slight narrowing of accepted plasma types (sodium citrate explicitly removed from new device description). However, the overall conclusion is still substantial equivalence. |
| Reportable Range (Serum, Plasma) | 0.7 - 11.0 mg/dL (Conv. Units) / 7 - 110 mg/L (SI Units) / 700 - 11000 ug/dL (Alt. Units) | 0.3 - 11.0 mg/dL (Conv. Units) / 3 - 110 mg/L (SI Units) / 300 - 11000 ug/dL (Alt. Units) | Improved lower detection limit (0.3 mg/dL vs 0.7 mg/dL). This is an improvement over the predicate, making it effectively equivalent or better in this aspect, which supports substantial equivalence. The upper limit remains the same. |
| Instrumentation | Vitros 250 and 950 Chemistry Systems | No Change (Same instrumentation) | Equivalent |
| Incubation time and temperature | 7.5 minutes at 37°C | No Change (Same incubation time and temperature) | Equivalent |
| Immobilized phosphorylcholine | 0.07 mg per cm² | No change (Implies 0.07 mg per cm²) | Equivalent |
| Anti-CRP antibody labeled with HRP | 0.0009 units per cm² | 0.0006 units per cm² | Different, however, the study concluded that despite this change, the overall performance (including the improved reportable range) demonstrates substantial equivalence. The implication is that this formulation change does not negatively impact performance but rather contributes to the improved lower detection limit. |
| Calcium chloride | 0.10 mg per cm² | 0.08 mg per cm² | Different, but similar to the anti-CRP antibody, the study concluded that the overall performance is substantially equivalent. |
| Leuco dye | 0.04 mg per cm² | No change (Implies 0.04 mg per cm²) | Equivalent |
Study that Proves the Device Meets Acceptance Criteria:
The study described is an equivalence study designed to show that the "Vitros Chemistry Products CRP Slides (modified)" are substantially equivalent to the "Vitros Chemistry Products CRP Slides (current/predicate)."
- Study Design: The information provided describes a comparison study between the new device and the predicate device. Equivalence was demonstrated by testing manufactured slides with patient and quality control samples.
- Performance Metrics: The implied performance metrics are the various assay characteristics listed in Table 1, particularly the reportable range and the ability to measure CRP values across that range accurately compared to the predicate. The key 'acceptance criteria' is the demonstration of substantial equivalence, which means the device performs at least as well as the legally marketed predicate device, and any differences do not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the test set. It mentions "patient and quality control samples," but no specific numbers are given.
- Data Provenance: Not specified. There is no mention of the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Ground Truth Establishment: For in vitro diagnostic assays like this, the "ground truth" is typically established by comparing results to a reference method or another already cleared device (in this case, the predicate device itself acts as the benchmark for comparison, along with quality control materials that have known values). It's not usually established by human expert consensus in the same way an imaging AI would be.
4. Adjudication Method:
- Adjudication Method: Not applicable in the context of this type of in vitro diagnostic device comparison study. Adjudication methods like 2+1 or 3+1 are relevant for interpreting ambiguous data (e.g., medical images) where human experts might disagree. For quantitative assays, the 'ground truth' is more objective (e.g., a measured concentration).
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:
- MRMC Study: No. This is an in vitro diagnostic device for quantitative measurement of C-reactive protein, not a device requiring human interpretation of medical images. Therefore, MRMC studies and concepts of human readers improving with AI assistance are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in effect. The device (VITROS Chemistry Products CRP Slides used on the VITROS Chemistry System) is an automated system for measuring CRP concentration. Its performance is inherent to the reagent slides and the instrument, requiring no human interpretation or "human-in-the-loop" decision-making for the actual measurement process once the sample is loaded. The "algorithm" here is the chemical reaction and spectrophotometric measurement process validated by the manufacturer.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the "modified" device, the ground truth was established by comparison to the predicate device (VITROS Chemistry Products CRP Slides, current slide) using "patient and quality control samples with measured CRP values." Quality control samples typically have known, certified values. Patient samples would have their CRP levels independently measured, presumably by the predicate device or a recognized reference method, to assess correlation and accuracy.
8. The Sample Size for the Training Set:
- Sample Size: The document does not specify a separate "training set." For this type of IVD device, the term "training" is not typically used for algorithm development in the same way it would be for machine learning. Instead, the product development and manufacturing process would involve internal testing and optimization (sometimes referred to as verification and validation activities), but not a distinct "training set" of patient data in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as no "training set" is described for algorithm development in the AI sense. The development of the slides (including the modified reagent composition) would have been based on established chemical principles and optimization to achieve desired performance characteristics.
Ask a specific question about this device
Page 1 of 1