Search Results
Found 20 results
510(k) Data Aggregation
(191 days)
Name: Optilite CH50 Reagent Optilite CH50 Controls Optilite CH50 Calibrator Regulation Number: 21 CFR §866.5240
The Optilite CH50 reagents are intended for the quantitative in vitro determination of total classical complement activity (CH50) in human serum using the Binding Site Optilite turbidimetric analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. This test should be used in conjunction with other laboratory and clinical findings. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
The Optilite CH50 calibrator is intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
The Optilite CH50 controls are intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is an FDA 510(k) clearance letter for the Optilite CH50 Reagent, Controls, and Calibrator, and it primarily focuses on the device's indications for use and regulatory compliance.
It does not include:
- A table of specific acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or training sets.
- Information on the number or qualifications of experts for establishing ground truth, or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- The type of ground truth used.
Therefore, I cannot fulfill your request based on the provided input.
Ask a specific question about this device
(240 days)
calibrator set for use on the SPAPLUS Human CH50 controls for use on the SPAPLUS Regulation Number: 21 CFR §866.5240
Human CH50 reagent pack for use on the SPA plus. These reagents are intended for the quantification of total classical complement activity (CH50) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests. Human CH50 calibrator set for use on the SPA plus The Human CH50 calibrator set is intended for use on the SPAPLUS in conjunction with the Binding Site Human CH50 reagent pack (product code: NK095.S) for the determination of total complement activity. Human CH50 controls for use on the SPA plus. The Human CH50 controls are intended for use in conjunction with the Binding Site Human CH50 reagent pack for use on the SPAPLUS (product code: NK095.S).
Not Found
This looks like a 510(k) clearance letter for an in vitro diagnostic (IVD) device, not a typical AI/ML-driven medical device. Therefore, many of the requested elements (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not directly applicable in the same way they would be for an AI algorithm that processes images or other complex data.
However, I can extract the acceptance criteria and performance information as typically presented in IVD submissions, focusing on analytical performance rather than diagnostic accuracy determined by human experts.
Here's the breakdown based on the provided text, interpreting "acceptance criteria" as the performance specifications and "reported device performance" as the results confirming those specifications:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) clearance letter and Indications for Use) does not contain the detailed acceptance criteria or the study results. This information is typically found in the 510(k) submission itself, often in sections detailing analytical performance studies (e.g., precision, accuracy, linearity, interfering substances). The clearance letter only confirms that the FDA reviewed the information and found the device substantially equivalent.
To illustrate what such a table would look like for an IVD, and as an example if this information were available in the submission, here's a hypothetical structure:
| Performance Characteristic | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Precision (Within-Run CV) | ≤ 5% | Sample A: 2.5%, Sample B: 3.1% |
| Precision (Total CV) | ≤ 8% | Sample A: 4.8%, Sample B: 5.9% |
| Accuracy (Bias vs. Reference) | Mean Bias ≤ 10% | Mean Bias: 3.7% |
| Linearity (R-squared) | > 0.98 | 0.995 |
| Interfering Substances | No significant interference (≤ 10% change) for common interferents at specified concentrations. | Met for hemoglobin, bilirubin, triglycerides (details would be in submission). |
| Detection Limit | Undisclosed range, but sufficient for clinical utility. | 5 CH50 U/mL (for example) |
| Range (Analytical Measurement Range) | 10 to 100 CH50 U/mL | 10 to 100 CH50 U/mL (confirmed) |
| Specificity | No cross-reactivity with indicated substances (e.g., C-reactive protein, other complement components) | Confirmed lack of significant cross-reactivity. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the clearance letter or the Indications for Use. For an IVD like this, "test set" would refer to the clinical samples used for analytical verification and validation studies.
- Sample Size: Unknown from this document. IVD studies typically use a range of samples for different studies (e.g., dozens for precision, hundreds for accuracy, specific spiked samples for interference).
- Data Provenance: Unknown from this document. Such studies often use samples collected from various clinical sites, and the country of origin would be part of the detailed study reports within the 510(k) submission. They are typically prospective or retrospective clinical samples, chosen to represent the target patient population.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This specific type of "expert ground truth" as it applies to AI/ML algorithms (e.g., radiologists interpreting images) is not applicable here. For an IVD measuring a biomarker like CH50, the "ground truth" is established through:
- Reference Methods: Comparing the device's results to a recognized, often more laborious or expensive, reference method for CH50 measurement.
- Certified Reference Materials: Using materials with known, assigned CH50 values.
- Clinical Outcomes/Pathology (indirectly): While CH50 levels are used in the diagnosis of immunological disorders, the "ground truth" for the device's measurement itself is analytical accuracy, not a clinical diagnosis established by interpreting the results alone.
4. Adjudication Method for the Test Set
Not Applicable in the context of expert adjudication for an IVD measuring a specific analyte. Adjudication applies to subjective interpretations, not quantitative measurements compared to a reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. MRMC studies are used for evaluating human reader performance, often with imaging devices, and are not relevant for a quantitative in vitro diagnostic like a CH50 reagent pack.
6. Standalone Performance
Yes, in a way. An IVD device's performance is its standalone performance. The studies performed to support this 510(k) would have demonstrated the analytical performance of the "Human CH50 reagent pack for use on the SPAPLUS" system as a whole, without human interpretation of raw data (other than running the instrument and interpreting the quantitative result displayed).
7. Type of Ground Truth Used
The ground truth for an IVD measuring a specific analyte like CH50 would typically be established by:
- Reference Methods: Comparison against established, often gold-standard, laboratory methods for CH50 (e.g., standard hemolytic assays).
- Calibrators and Controls: Using materials with precisely assigned values, traceable to international standards if available.
- Spiked Samples: Samples engineered with known concentrations of the analyte to test linearity and recovery.
8. Sample Size for the Training Set
Not Applicable. This is an IVD reagent and calibrator/control set, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a system involves the chemical and biological formulation of reagents, optimization of the analytical method, and instrument calibration, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
Not Applicable for an IVD reagent system. The concept of "ground truth for a training set" specifically applies to machine learning algorithms.
Ask a specific question about this device
(198 days)
7121
Re: K100455
Trade/Device Name: Human C4 Kit for use on SPAPLUSTM Regulation Number: 21 CFR § 866.5240
This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings
Not Found
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "Human C4 Kit for use on SPAPLUS™," indicating that the device is substantially equivalent to legally marketed predicate devices.
The document includes:
- Device Name: Human C4 Kit for use on SPAPLUS™
- Intended Use: For the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. To be used in conjunction with other laboratory and clinical findings.
- Regulatory Information: Regulation Number, Regulation Name, Regulatory Class, Product Code, and 510(k) Number.
However, it does not provide the following information requested in the prompt:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document is a regulatory approval notice, not a detailed study report describing performance characteristics against acceptance criteria.
Ask a specific question about this device
(204 days)
7121
Re: K100179
Trade/Device Name: Human C3c Kit for use on SPAPLUSTM Regulation Number: 21 CFR §866.5240
This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device called "Human C3c Kit for use on SPAPLUSTM". It grants substantial equivalence to legally marketed predicate devices, but it does not contain a detailed study report with acceptance criteria, performance data, or information about sample sizes, ground truth establishment, or expert involvement as requested.
The document is an FDA clearance letter and an "Indications for Use" statement. It does not describe a performance study in the way a scientific paper or a detailed clinical trial report would.
Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving the device meets those criteria based only on the provided text. The text confirms the device's intended use and regulatory status but does not describe the specific performance study that led to its clearance.
Ask a specific question about this device
(154 days)
Complement C4, Specical Calibrator, Specitrol Control, Specitrol High Control Regulation Number: 21 CFR 866.5240
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
(84 days)
Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5240
Dimension Vista™ C3 Flex® reagent cartridge: The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
Dimension Vista™ C4 Flex® reagent cartridge: The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (IGM) on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H: Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension Vista™ System.
Dimension Vista™ C3 and C4 Flex® reagent cartridges: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a calibrator of known concentration.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing, C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoqlobulin M (IGM).
Dimension Vista™ Protein 1 Controls L/M/H: Protein 1 Controls L/M/H are multi-analyte, liquid human serum based products containing C3 Complement, C4 Complement, Immunoglobulin A, Immunoglobulin G and lmmunoglobulin M (IGM).
This 510(k) summary describes a new in vitro diagnostic (IVD) device, the Dimension Vista™ C3 and C4 Flex® reagent cartridges, along with associated calibrators and controls. The device is intended for the quantitative measurement of complement C3 and C4 in human serum and heparinized plasma on the Dimension Vista™ System, to aid in the diagnosis of immunologic disorders.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Dade Behring N Antisera to Human Complement Factors (C3c, C4) assays). However, it does not contain the specific information required to complete most sections of your request. This is common for 510(k) summaries of IVDs like reagent cartridges, which rely on analytical performance parameters (e.g., accuracy, precision, linearity, interference) rather than clinical studies with human readers or ground truth established by experts in the same way an imaging AI device would.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text only briefly mentions that the "result is evaluated by comparison with a calibrator of known concentration" and that the device is "substantially equivalent" to the predicate. It does not provide explicit acceptance criteria (e.g., specific thresholds for coefficient of variation, bias, or correlation with a reference method) or a table of performance data against those criteria. This type of detailed analytical performance data would typically be found in the full 510(k) submission, not in the summary or clearance letter.
2. Sample size used for the test set and the data provenance
The document does not specify test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective). For IVD devices like this, the "test set" would typically refer to a panel of patient samples used to evaluate various analytical performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of IVD device. Ground truth for an assay measuring C3/C4 levels would be established by reference methods or gravimetric preparations, not by expert review of patient cases.
4. Adjudication method for the test set
This information is not applicable to this type of IVD device.
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
No such study was mentioned or would typically be relevant for a diagnostic assay measuring a biomarker. MRMC studies are primarily used for imaging AI devices that assist human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an automated in vitro diagnostic test. Its "standalone" performance is its performance, as it quantifies complement levels automatically. However, the document does not present the specific standalone performance metrics.
7. The type of ground truth used
For an IVD measuring complement C3 and C4, the "ground truth" for evaluating its analytical performance would be established through:
- Reference Methods: Comparison against established, highly accurate laboratory methods for measuring C3 and C4.
- Certified Reference Materials/Calibrators: Using materials with known, accurately assigned concentrations of C3 and C4.
- Gravimetric/Volumetric Preparation: For controls and calibrators, the known concentrations are established by precise preparation.
The provided document mentions the Dimension Vista™ Protein 1 Calibrator and Controls, which are used to establish and monitor the assay's performance against known concentrations.
8. The sample size for the training set
This information is not applicable. This device is a reagent cartridge and an instrument system, not a machine learning model that requires a "training set" in the conventional AI sense. Its performance is based on the underlying chemical reactions and optical detection, not on learning from a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this IVD device.
Ask a specific question about this device
(48 days)
Complement Factors (C3c and C4) / Complement components C3, C4 immunological test system, Class II (866.5240
K050005
Trade/Device Name: N Antisera to Human Complement Factors (C3c, C4) Regulation Number: 21 CFR 866.5240
In vitro diagnostic reagents for the quantitative determination of complement factors (C3/C3c and C4/C4c) in human serum or heparinized or EDTA plasma by means of immunonephelometry on the BN* Systems as an aid in the diagnosis of immunologic disorders associated with complement C3 or C4 protein.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific, purified rabbit antibodies to human C3 and C4.
Acceptance Criteria and Study for N Antisera to Human Complement Factors (C3c, C4)
This submission describes the acceptance criteria and the study that proves the device meets those criteria for the N Antisera to Human Complement Factors (C3c, C4). The primary focus of this submission is to demonstrate equivalence in performance when expanding the intended use to include heparinized or EDTA plasma as specimen types, in addition to serum.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Serum to Plasma Equivalence | Correlation coefficient between serum and heparinized plasma measurements ≥ 0.95 | 0.98 - 0.99 | This range meets the acceptance criteria, demonstrating strong correlation. |
| Serum to Plasma Equivalence | Correlation coefficient between serum and EDTA plasma measurements ≥ 0.95 | 0.98 - 0.99 | This range meets the acceptance criteria, demonstrating strong correlation. |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the test set (number of patient samples) is not explicitly stated in the provided document. The study performed "method comparisons" to demonstrate equivalence.
The data provenance (country of origin, retrospective or prospective) is not explicitly stated. However, given it's a 510(k) submission for a device marketed by Dade Behring Marburg GmbH (Germany) and Dade Behring Inc. (USA), it's likely a controlled, prospective validation study conducted in a laboratory setting, potentially using samples from a relevant patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The ground truth for this device is not established by expert clinical review of images or diagnoses. Instead, the accuracy of the device is assessed by its ability to quantitatively determine complement factors, where established laboratory methods serve as the reference for comparison.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of medical data (e.g., imaging studies) where multiple experts resolve discrepancies. For quantitative assays like this, agreement is assessed statistically.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed and is not relevant for this type of in vitro diagnostic device. MRMC studies evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images or data. This submission focuses on the analytical performance of a quantitative assay.
6. Standalone (Algorithm Only) Performance Study
This is an in vitro diagnostic assay, not an algorithm or AI system in the traditional sense. The "device" itself is the reagent. Therefore, a "standalone algorithm performance" study is not applicable. The performance is intrinsically linked to the assay's ability to accurately measure the target analytes. The study explicitly focuses on the analytical performance of the assay and its reagents in different sample matrices.
7. Type of Ground Truth Used
The ground truth for the test set was established by comparison to serum measurements using the current, legally marketed N Antisera to Human Complement Factors (C3c and C4) assays.
The study essentially compares the quantitative results obtained from heparinized or EDTA plasma samples with the quantitative results obtained from serum samples (which represent the established "ground truth" or reference for this assay type). The correlation coefficients of 0.98-0.99 indicate that the measurements in plasma are highly consistent with those in serum.
8. Sample Size for the Training Set
This information is not applicable. This device is a reagent for a quantitative diagnostic assay. It does not employ machine learning or AI models that require a "training set" in the conventional sense. The "learning" or optimization of the assay's performance would occur during its initial development and validation stages through extensive analytical testing, not through a "training set" like an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of in vitro diagnostic device, as explained in point 8.
Ask a specific question about this device
(35 days)
20 VITROS Chemistry Products Protein Performance Verifiers I, II and III
Regulation Number: 21 CFR 866.5240
4.4 Classification Names
Classification Name: Complement components immunological test systems (866.5240
For in vitro diagnostic use only. VITROS Chemistry Products C3 Reagent is used to quantitatively measure complement C3 (C3) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.
For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products C4 Reagent is used to quantitatively measure complement C4 (C4) concentration in human serum and plasma. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
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 System 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 C3 Reagent, VITROS Chemistry Products C4 Reagent, VITROS Chemistry Products Calibrator Kit 20 and VITROS Chemistry Products Protein Performance Verifiers I, II and III), which are combined on the VITROS 5,1 FS Chemistry System to perform the VITROS C3 and C4 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).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
The document describes the submission of a 510(k) premarket notification for several in vitro diagnostic devices, including VITROS Chemistry Products C3 Reagent, VITROS Chemistry Products C4 Reagent, VITROS Chemistry Products Calibrator Kit 20, and VITROS Chemistry Products Protein Performance Verifiers I, II and III. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for a new clinical performance study. Instead, the "acceptance criteria" are implied by the statistical correlation to the predicate devices.
| Device Characteristic | VITROS C3 assay (New Device #1) | Beckman C3 assay (Predicate Device #1) | VITROS C4 assay (New Device #2) | Dade Behring C4 assay (Predicate Device #2) |
|---|---|---|---|---|
| Correlation to Predicate | Y = 0.95X + 11 mg/dL | N/A | Y = 0.93X + 3.0 mg/dL | N/A |
| Correlation Coefficient (r) | 0.98 | N/A | 0.976 | N/A |
| Reportable Range | 40 - 380 mg/dL | 35 - 350 mg/dL | 8.0 - 60.0 mg/dL | 6 - 190 mg/dL |
| Method | Immunoturbidimetry | Rate nephelometry | Immunoturbidimetry | Rate nephelometry |
| Instrumentation | VITROS 5,1 FS Chemistry Systems | IMMAGE Immunochemistry Systems | VITROS 5,1 FS Chemistry Systems | Dade Behring BN® ProSpec Nephelometer |
| Sample type | Serum and plasma | Serum | Serum and plasma | Serum |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size used for the correlation studies for C3 and C4 assays, nor does it specify the country of origin of the data. It generally refers to "patient samples" and "commercially available reagents." The studies appear to be retrospective analyses comparing the new device's performance to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The ground truth for the test set is established by the results obtained from the predicate devices, which are already legally marketed and established diagnostic systems. There is no mention of expert consensus for establishing ground truth in this submission.
4. Adjudication Method for the Test Set:
Not applicable. The study design involves direct comparison and correlation between the new device's measurements and those of the predicate devices. There is no mention of an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This document describes the performance of an in vitro diagnostic device (reagents and calibrators) used in a laboratory setting for quantitative measurement. It is not an imaging device or a system that involves human readers interpreting cases in a multi-reader, multi-case study.
6. Standalone Performance Study:
Yes, a standalone performance study in the form of correlation studies, precision, analytical sensitivity, specificity, and expected values was performed for the VITROS C3 and C4 assays, comparing them to the predicate devices. This demonstrates the algorithm-only performance in relation to established methods.
7. Type of Ground Truth Used:
The ground truth used for these studies is the measurement values obtained from the legally marketed predicate devices. The new devices' performance is assessed by how well their results correlate with those produced by the predicate devices.
8. Sample Size for the Training Set:
The document does not explicitly state a "training set" sample size in the context of machine learning or AI models. The development and validation of these in vitro diagnostic reagents would have involved extensive R&D and internal testing, which would serve a similar function to a training set, but no specific numbers are publicly disclosed in this 510(k) summary.
9. How Ground Truth for the Training Set Was Established:
Not explicitly stated. For in vitro diagnostic devices, the "training" (development and optimization) would typically involve using known reference materials, spiked samples, and characterized patient samples, with their true values established through highly accurate reference methods or clinical standards. This information is usually part of internal development and not fully detailed in a 510(k) summary focused on substantial equivalence.
Ask a specific question about this device
(127 days)
Stroudsburg, PA 18301
Re: K032796
Trade/Device Name: IBL C3d-CIC EIA test Regulation Number: 21 CFR 866.5240
The IBL C3d-CIC test is a semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum.
I apologize, but the provided text from the FDA 510(k) clearance letter for the "IBL C3d-CIC EIA Test" does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The letter primarily covers:
- The FDA's determination of substantial equivalence to a predicate device.
- Regulatory classifications and requirements.
- Contact information for various FDA offices.
- The "Indications For Use" statement for the device.
It explicitly states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA's decision is based on a comparison to an existing device, rather than a detailed presentation of a new study demonstrating performance against specific acceptance criteria within this document. Such study details are typically found in the full 510(k) submission, which is not provided here.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or performance metrics for the IBL C3d-CIC EIA Test itself.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: Not applicable, as this is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging device for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is an IVD kit, not an algorithm. Its performance is its standalone performance.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The "Indications For Use" section provides context for the device's purpose:
- Device Name: IBL C3d-CIC EIA Test
- Indications For Use: A semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
To get the information you're looking for, one would need access to the full 510(k) submission document (Premarket Notification) itself, which contains the detailed scientific and clinical data submitted to the FDA.
Ask a specific question about this device
(114 days)
BINDAZYME C1q Binding Circulating Immune Complex Enzyme Immunoassay Kit Regulation Number: 21 CFR § 866.5240
This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings.
Not Found
This FDA document is a 510(k) clearance letter for the BINDAZYME C1q Binding Circulating Immune Complex Enzyme Immunoassay Kit. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It notes the "Indications for Use" but does not detail performance metrics, study designs, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text.
Ask a specific question about this device
Page 1 of 2