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510(k) Data Aggregation
(204 days)
CZW
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.
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(154 days)
CZW
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.
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(84 days)
CZW
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.
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(48 days)
CZW
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.
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(35 days)
CZW
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.
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(127 days)
CZW
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.
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C3 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry.
C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry.
The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.
The SYNCHRON LX® C3 and C4 Reagents are designed for optimal performance on the SYNCHRON LX® Systems. The reagent kit contains two 100-test cartridges that are packaged separately from the associated calibrators. The LX CAL 1 kit contains four 3 mL - bottles.
This is a 510(k) premarket notification for in vitro diagnostic devices. These submissions typically do not contain detailed acceptance criteria and study designs in the same way that studies for AI/ML-based medical devices or devices undergoing clinical trials might. Instead, they focus on demonstrating substantial equivalence to a predicate device through performance data.
Based on the provided text, here's an analysis of the "acceptance criteria" and "study" information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents performance data (method comparison, imprecision, and anticoagulant studies) to demonstrate the device's characteristics and its equivalence to the predicate.
Here's an attempt to structure the provided performance data, inferring the underlying objectives:
| Performance Metric | Inferred Acceptance Criteria (Implicit) | Reported Device Performance (SYNCHRON LX) |
|---|---|---|
| Method Comparison (C3) | Slope approximately 1.0, Intercept approximately 0, r (correlation) close to 1.0, Confidence Intervals indicating precision around these values, demonstrating equivalence to IMMAGE C3 Reagent. | Slope: 1.025 (Confidence: 0.023) |
| Intercept: 2.307 (Confidence: 2.783) | ||
| r: 0.992 | ||
| n: 134 samples (compared to IMMAGE C3 Reagent) | ||
| Method Comparison (C4) | Slope approximately 1.0, Intercept approximately 0, r (correlation) close to 1.0, Confidence Intervals indicating precision around these values, demonstrating equivalence to IMMAGE C4 Reagent. | Slope: 1.001 (Confidence: 0.027) |
| Intercept: 0.938 (Confidence: 0.717) | ||
| r: 0.985 | ||
| n: 160 samples (compared to IMMAGE C4 Reagent) | ||
| C3 Imprecision (Within-Run) | Low % C.V. (Coefficient of Variation) indicating good repeatability. | Serum Control 1: Mean 55.6 mg/dL, SD 0.97, % C.V. 1.75 |
| Serum Control 2: Mean 170.8 mg/dL, SD 2.20, % C.V. 1.29 | ||
| Serum Control 3: Mean 237.4 mg/dL, SD 2.27, % C.V. 0.96 | ||
| Serum Pool 1: Mean 28.9 mg/dL, SD 0.49, % C.V. 1.71 | ||
| C3 Imprecision (Total) | Low % C.V. indicating good reproducibility. | Serum Control 1: Mean 55.6 mg/dL, SD 1.21, % C.V. 2.19 |
| Serum Control 2: Mean 170.8 mg/dL, SD 2.44, % C.V. 1.43 | ||
| Serum Control 3: Mean 237.4 mg/dL, SD 2.92, % C.V. 1.23 | ||
| Serum Pool 1: Mean 28.9 mg/dL, SD 0.57, % C.V. 1.98 | ||
| C4 Imprecision (Within-Run) | Low % C.V. indicating good repeatability. | Serum Control 1: Mean 25.1 mg/dL, SD 0.40, % C.V. 1.59 |
| Serum Control 2: Mean 38.0 mg/dL, SD 0.50, % C.V. 1.32 | ||
| Serum Control 3: Mean 50.1 mg/dL, SD 0.85, % C.V. 1.70 | ||
| Serum Pool 1: Mean 9.5 mg/dL, SD 0.23, % C.V. 2.37 | ||
| Serum Pool 2: Mean 70.3 mg/dL, SD 1.07, % C.V. 1.53 | ||
| C4 Imprecision (Total) | Low % C.V. indicating good reproducibility. | Serum Control 1: Mean 25.1 mg/dL, SD 0.46, % C.V. 1.82 |
| Serum Control 2: Mean 38.0 mg/dL, SD 0.64, % C.V. 1.68 | ||
| Serum Control 3: Mean 50.1 mg/dL, SD 1.09, % C.V. 2.17 | ||
| Serum Pool 1: Mean 9.5 mg/dL, SD 0.29, % C.V. 3.09 | ||
| Serum Pool 2: Mean 70.3 mg/dL, SD 1.34, % C.V. 1.91 | ||
| C3 Anticoagulant Study | Y ≈ X, r close to 1.0, demonstrating minimal interference from specified anticoagulants. | Lithium Heparin: Y = 0.966X + 0.28; r = 0.985 |
| Sodium Heparin: Y = 0.979X - 0.95; r = 0.979 | ||
| EDTA: Y = 0.855X + 5.27; r = 0.988 | ||
| C4 Anticoagulant Study | Y ≈ X, r close to 1.0, demonstrating minimal interference from specified anticoagulants. | Lithium Heparin: Y = 0.899X + 1.21; r = 0.978 |
| Sodium Heparin: Y = 0.900X + 0.76; r = 0.992 | ||
| EDTA: Y = 0.967X + 0.34; r = 0.985 |
2. Sample Size for the Test Set and Data Provenance:
- Method Comparison:
- C3 Reagent: n = 134 samples
- C4 Reagent: n = 160 samples
- Imprecision Studies:
- For each sample type (Serum Controls, Serum Pools) in both C3 and C4, N = 80 measurements were performed (this seems to combine within-run and total imprecision measurements, implying 80 distinct runs/samples for each data point).
- Anticoagulant Studies: The number of samples for each anticoagulant type is not explicitly stated, but Deming Regression Analysis was performed.
- Data Provenance: Not explicitly mentioned (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing the new device against a predicate or evaluating its performance characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This type of information is not applicable to this submission. This device is an in vitro diagnostic (IVD) reagent for quantitative measurement of C3 and C4 proteins in human serum or plasma. The "ground truth" here is the actual concentration of these proteins, as measured by a established, legally marketed predicate device (Beckman IMMAGE C3 and C4 Reagents) or by control materials with known values. There are no human "experts" establishing a subjective "ground truth" for the test set of an IVD.
4. Adjudication Method for the Test Set:
Not applicable. As the "ground truth" is based on quantitative measurements by a predicate device or control materials, there is no need for human adjudication.
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:
Not applicable. This submission is for an IVD reagent and calibrator, not an AI/ML-based diagnostic imaging or detection system that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone diagnostic test in the sense that its performance is evaluated directly through its ability to accurately measure analyte concentrations. It doesn't involve a human-in-the-loop for interpretation beyond standard laboratory procedures for running the assay and reviewing results. It's essentially an "algorithm only" in that the chemical reactions and optical detection on the SYNCHRON LX System constitute its operational mechanism.
7. The type of ground truth used:
The ground truth for the performance studies is established by:
- Predicate Method: For method comparison studies, the results obtained from the new SYNCHRON LX C3/C4 Reagents are compared to those obtained from the legally marketed Beckman IMMAGE C3/C4 Reagents. The IMMAGE system (nephelometry) serves as the reference method.
- Known Control Values: For imprecision studies, commercial Serum Control materials with established target values are used, along with Serum Pools. These controls inherently have known or very well-characterized concentrations, which act as the ground truth for evaluating variability.
8. The sample size for the training set:
Not applicable. This submission is for a traditional IVD reagent, not an AI/ML device that requires a training set. The "development" of the reagent relies on chemical formulation and optimization, not machine learning from a data set.
9. How the ground truth for the training set was established:
Not applicable. (See point 8).
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For the in vitro quantitative immunological determination of human complement C3c in serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
The Tina-quant Complement C3c ver.2 Test System is based on the activation of the complement system which takes place via a classical and an alternative route. The two pathways come together in a joint terminal path. As a complement factor C3 is a factor common to both pathways, the concentration of C3 and its degradation products (including C3c) can be evaluated as a parameter for activation of the complement system. Human C3c forms a precipitate with a specific antiserum which is determined turbidimetrically.
The provided text describes a 510(k) summary for the Tina-quant Complement C3c ver.2 Test System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific acceptance criteria through a novel study. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance studies, and training set details) is not typically included in a 510(k) summary focused on substantial equivalence for an in vitro diagnostic (IVD) device like this one.
However, I can extract the relevant information regarding the acceptance criteria (as implied by comparison to the predicate) and the reported device performance.
1. Table of Acceptance Criteria and Reported Device Performance
For IVD devices seeking 510(k) clearance, the "acceptance criteria" are generally that the new device's performance characteristics demonstrate substantial equivalence to the predicate device. This is shown by comparing key analytical performance parameters.
| Performance Characteristic | Acceptance Criteria (Predicate Device K951595) | Reported Device Performance (Tina-quant Complement C3c ver.2) |
|---|---|---|
| Intended Use | For the in vitro quantitative immunological determination of human complement C3c in serum. | For the in vitro quantitative immunological determination of human complement C3c in serum and plasma. |
| Indication for Use | Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. | Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. |
| Sample Type | Human serum | Human serum and plasma |
| Analytical Sensitivity | 0.262 g/L (26 mg/dL) | 0.11 g/L (11 mg/dL) |
| Wavelength | 340/659 nm | 340/659 nm |
| Analyzer | COBAS Integra analyzers | COBAS Integra analyzers |
| Measuring Range | 0.55-8.9 g/L (55-890 mg/dL) | 0.11-6.0 g/L (11-600 mg/dL) |
Study Description:
The study proving the device meets the acceptance criteria (i.e., demonstrates substantial equivalence) is a comparison study against the predicate device, Tina-quant Complement C3c Test System (K951595). The summary states: "The table below indicates the similarities between the modified Tina-quant Complement C3c ver.2 Test System on COBAS Integra analyzers and the predicate, Tina-quant Complement C3c Test System on COBAS Integra analyzers (K951595). In summary, the Tina-quant Complement C3c ver.2 Test System described in this submission is, in our opinion, substantially equivalent to the predicate device."
This comparison highlights that the new device has a broader sample type (includes plasma) and improved analytical sensitivity (lower detection limit) compared to the predicate, while maintaining the same intended use (with expanded sample type), indications for use, wavelength, and analyzer. The measuring range has also shifted to a lower limit, providing a broader range at the lower end.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For IVD devices comparing performance to a predicate, studies would typically involve a sufficient number of patient samples to demonstrate equivalent or improved performance across various concentrations and clinical conditions. However, the exact number is not detailed in this summary.
- Data Provenance: Not explicitly stated. Given it's a product performance comparison, the data would likely be from laboratory testing. It's not specified if it's retrospective or prospective, nor the country of origin.
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 and not included in the provided 510(k) summary. For an IVD device measuring an analyte concentration, "ground truth" is typically established through reference methods, calibrated standards, or validated internal procedures, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
- Not applicable and not included. Adjudication methods like "2+1" or "3+1" are relevant for performance studies where human interpretation of medical images or other complex data is being assessed, often with multiple readers. For an automated IVD test measuring an analyte, this type of adjudication is not part of the performance evaluation.
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:
- Not applicable. This device is an automated in vitro diagnostic test for measuring an analyte (Complement C3c concentration). It does not involve human readers interpreting images, nor does it incorporate AI assistance for diagnostic interpretation. Therefore, an MRMC study or AI-related effectiveness is irrelevant for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device itself is an automated laboratory analyzer for quantitative immunological determination. Its performance is inherently "standalone" in the sense that it provides a quantitative measurement directly, without requiring human interpretation during the measurement process. The study compares the performance characteristics of this automated system to its predicate, also an automated system.
7. The type of ground truth used:
- The "ground truth" for this type of IVD device is generally based on the accurate measurement of the analyte (human complement C3c) using established reference methods, calibrated standards, and quality control materials. The summary does not explicitly state the reference method used to establish the "truth" for the samples tested, but it is implied to be analytical accuracy and precision determined through standard laboratory practices for IVD validation.
8. The sample size for the training set:
- Not applicable. This device is a quantitative immunoassay test system, not a machine learning or AI-based algorithm that requires a "training set" in the computational sense. Its performance is based on the chemical and immunological reactions and the associated detection system.
9. How the ground truth for the training set was established:
- Not applicable for the same reasons as #8.
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