Search Results
Found 1 results
510(k) Data Aggregation
(154 days)
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
For in vitro diagnostic use in the quantitative determination of the complement C3 concentration in human serum on the T60 analyzer.
For in vitro diagnostic use in the quantitative determination of the complement C4 concentration in human serum on the T60 analyzer.
The complement C3 and complement C4 are intended for quantative in-vitro diagnostic determination of the complement C3 and C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 and C4 measurements may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
Not Found
The provided document describes the Thermo Electron Oy Complement C3 and C4 diagnostic test systems, along with associated calibrators (SpeciCal) and controls (SpeciTrol and SpeciTrol High). These devices are intended for the quantitative determination of complement C3 and C4 concentrations in human serum on the T60 analyzer to aid in the diagnosis of immunologic disorders.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides performance characteristics for both Complement C3 and Complement C4, comparing the new device (Thermo Electron Oy's T60 analyzer) with predicate devices (Bayer Clinical Method for ADVIA 1650). The acceptance criteria are implied by the reported performance, which demonstrates comparable results to the legally marketed predicate devices.
Complement C3 Acceptance Criteria and Performance
| Attribute | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of complement C3 concentration in human serum on an ADVIA® Chemistry System, aiding in diagnosis of inherited/acquired deficiencies, inflammatory, and necrotic disorders. | Quantitative determination of complement C3 concentration in human serum on the T60 analyzer, aiding in diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. (Similar to predicate) |
| Assay Protocol | PEG enhanced immunoturbidimetric | PEG enhanced immunoturbidimetric (Same as predicate) |
| Traceability/ Standardization | IRMM reference Material CRM 470 from IFCC evaluated and found to recover 97% of target concentration. | Value of Complement C3 assigned using IFCC preparate CRM 470 as a primary reference. (Comparable to predicate) |
| Sample Type | Human serum | Human serum (Same as predicate) |
| Reagent Storage | Unopened reagents stable until expiration date at 2°C - 8°C, protected from light. | Reagents in unopened vials stable at 2...8 °C until expiration date. (Similar to predicate) |
| Measuring Range | 0.46 mg/dL to the C3 concentration in the Liquid Specific Protein Calibrator Level 6. | 28* – 513 mg/d* (*The values are related to the Complement C3 concentration of the calibrator and are lot dependent.) (Range covers/exceeds predicate) |
| Precision (Within run - CV%) | Level 64.02 mg/dL: 1.2% | |
| Level 124.13 mg/dL: 2.1% | ||
| Level 182.35 mg/dL: 2.1% | Level 33 mg/dL: 1.4% | |
| Level 42 mg/dL: 1.3% | ||
| Level 89 mg/dL: 0.8% | ||
| Level 216 mg/dL: 0.9% | ||
| Level 406 mg/dL: 0.8% | ||
| Level 441 mg/dL: 0.5% (Comparable or better than predicate) | ||
| Precision (Total - CV%) | Level 64.02 mg/dL: 6.5% | |
| Level 124.13 mg/dL: 7.0% | ||
| Level 182.35 mg/dL: 6.7% | Level 33 mg/dL: 3.7% | |
| Level 42 mg/dL: 3.0% | ||
| Level 89 mg/dL: 2.3% | ||
| Level 216 mg/dL: 2.4% | ||
| Level 406 mg/dL: 1.8% | ||
| Level 441 mg/dL: 2.0% (Significantly better than predicate) | ||
| Method Comparison | y = 1.06x - 6.47, r = 0.952 (for n=40 samples in range 44.6 - 250.6 mg/dL between Bayer RA Complement C3 reagent on ADVIA 1650 and predicate) | y = 0.98x + 4.99, R = 0.989 (for n=102 samples in range 28 to 299 mg/dL) (Slope closer to 1, higher R-value, broader range of samples compared to predicate's comparison method) |
| Limitations (Interference) | Bilirubin (conjugated) ≤ 25 mg/dL | |
| Bilirubin (unconjugated) ≤ 18.75 mg/dL | ||
| Hemoglobin ≤ 1000 mg/dL | ||
| Triglyceride (concentrate) ≤ 1000 mg/dL (No interference found up to these levels) | Lipemia: No interference up to 500 mg/dL (5 g/l) of Intralipid. | |
| Hemolysate: No interference up to 1000 mg/dl (10 g/l) of hemoglobin. | ||
| Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). | ||
| Bilirubin, unconjugated: No interference up to 58 mg/dl (1000 µmol/l). (Comparable or better than predicate in tested levels) |
Complement C4 Acceptance Criteria and Performance
| Attribute | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of complement C4 concentration in human serum on an ADVIA® Chemistry System, aiding in diagnosis of inherited/acquired deficiencies, inflammatory, and necrotic disorders. | Quantitative determination of complement C4 concentration in human serum on the T60 analyzer, aiding in diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. (Similar to predicate) |
| Assay Protocol | PEG enhanced immunoturbidimetric | PEG enhanced immunoturbidimetric (Same as predicate) |
| Traceability/ Standardization | IRMM reference Material CRM-470 from IFCC evaluated and found to recover 103% of target concentration. | Value of Complement C4 assigned using IFCC preparate CRM 470 as a primary reference. (Comparable to predicate) |
| Sample Type | Human serum | Human serum (Same as predicate) |
| Reagent Stability | Unopened reagents stable until expiration date at 2°C - 8°C, protected from light. | Reagents in unopened vials stable at 2 ... 8 °C until expiration date. (Similar to predicate) |
| Measuring Range | From 0.36 mg/dL to the C3 concentration in the Liquid Specific Protein Calibrator Level 6. | 6* - 103* mg/dl (*The values are related to the Complement C4 concentration of the calibrator and are lot dependent.) (Range covers/exceeds predicate) |
| Precision (Within run - CV%) | Level 19.03 mg/dL: 1.1% | |
| Level 35.51 mg/dL: 1.6% | ||
| Level 51.70 mg/dL: 2.9% | Level 8 mg/dL: 1.3% & 1.5% | |
| Level 16 mg/dL: 1.7% | ||
| Level 46 mg/dL: 2.2% | ||
| Level 78 mg/dL: 1.0% | ||
| Level 88 mg/dL: 0.8% (Comparable or better than predicate) | ||
| Precision (Total - CV%) | Level 19.03 mg/dL: 4.0% | |
| Level 35.51 mg/dL: 5.0% | ||
| Level 51.70 mg/dL: 5.1% | Level 8 mg/dL: 2.8% & 2.7% | |
| Level 16 mg/dL: 3.5% | ||
| Level 46 mg/dL: 4.4% | ||
| Level 78 mg/dL: 1.7% | ||
| Level 88 mg/dL: 1.7% (Better than predicate) | ||
| Method Comparison | y = 0.84x + 2.33, r = 0.976 (for n=50 samples in range 10.1 – 59.1 mg/dL between Bayer RA Complement C4 reagent on ADVIA 1650 and predicate) | y = 0.99x – 0.18, R = 0.995 (for n=88 samples in range 3 to 88 mg/dl) (Slope closer to 1, higher R-value, broader range of samples compared to predicate's comparison method) |
| Limitations (Interference) | Bilirubin (conjugated) ≤18.75 mg/dL | |
| Bilirubin (unconjugated) ≤18.75 mg/dL | ||
| Hemoglobin ≤750 mg/dL | ||
| Triglyceride (concentrate) ≤1000 mg/dL (No interference found up to these levels) | Lipemia: No interference up to 300 mg/dL (3 g/l) of Intralipid®. | |
| Hemolysate: No interference up to 1000 mg/dL (10 g/l) of hemoglobin. | ||
| Bilirubin, conjugated: No interference up to 58 mg/dL (1000 µmol/l). | ||
| Bilirubin, unconjugated: No interference up to 58 mg/dL (1000 µmol/l). (Comparable or better than predicate in tested levels) |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Complement C3:
- Method Comparison (Linearity/Accuracy): N = 102 samples.
- Precision: Not explicitly stated, but data is typically derived from replicate measurements of control materials or patient samples over several days/runs. The listed levels cover various concentrations (e.g., 33, 42, 89, 216, 406, 441 mg/dL).
- Interference: Specific levels of interferents (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested.
- Data Provenance: Not explicitly stated, but typically these types of studies for in vitro diagnostic devices are prospective and conducted in a controlled laboratory environment. The country of origin is not mentioned.
-
Complement C4:
- Method Comparison (Linearity/Accuracy): N = 88 samples.
- Precision: Not explicitly stated, but data is typically derived from replicate measurements of control materials or patient samples over several days/runs. The listed levels cover various concentrations (e.g., 8, 16, 46, 78, 88 mg/dL).
- Interference: Specific levels of interferents (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested.
- Data Provenance: Not explicitly stated, but typically these types of studies for in vitro diagnostic devices are prospective and conducted in a controlled laboratory environment. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For in vitro diagnostic (IVD) devices, "ground truth" for method comparison and precision studies is typically established by comparing the new device's results to a more established, often FDA-cleared or gold standard, method (the predicate device in this case, on a different analyzer) or to known concentrations in control materials. The predicate devices are already considered to have an established "ground truth" for their measurements.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation (e.g., radiological reads) is involved and discrepancies need to be resolved. For quantitative in vitro diagnostic assays, the comparison is made directly between numerical results from the new device and the predicate device or reference values, not through an adjudication process by experts.
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 information is not applicable. This document describes an in vitro diagnostic (IVD) device, specifically a quantitative assay for complement proteins. It is not an AI-assisted diagnostic imaging device or a system that involves human readers interpreting data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an automated chemistry analyzer (T60 analyzer) that performs quantitative measurements. The "algorithm" in this context refers to the assay's chemical reactions and measurement principles. The performance data presented (precision, linearity, method comparison, interference) reflects the standalone performance of the T60 analyzer with the specified reagents. There isn't a separate "algorithm only" component distinct from the device's operational performance that would be reported independently outside of human intervention. It is inherently a standalone analytical system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For these in vitro diagnostic assays, the "ground truth" for evaluating the new device's performance is established through:
- Comparison to a Predicate Device/Method: The primary method comparison studies use the Bayer Clinical Method for ADVIA 1650 Complement C3 and C4 as the reference. The assumption for substantial equivalence is that the predicate device's results are considered accurate and reliable.
- Reference Materials: For traceability and standardization, the IFCC preparate CRM 470 is used as a primary reference. This is a certified reference material with assigned values, serving as a form of "ground truth" for calibration.
- Known Concentrations: For precision and linearity studies, control materials or spiked samples with known or established concentrations are typically used.
8. The Sample Size for the Training Set
This information is not applicable/provided. The described device is a quantitative in vitro diagnostic assay, not a machine learning or AI-based system that typically uses a "training set" in the computational sense. The "development" of the assay involves optimizing reagents and protocols, and validating performance on a test set (as described above), but not a data-driven training process in the way AI models are trained.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of this IVD device.
Ask a specific question about this device
Page 1 of 1