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510(k) Data Aggregation
(117 days)
C-REACTIVE PROTEIN (LATEX)
Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Measurement of c-reactive protein aids in the evaluation of the amount of injury to body tissues.
The C-Reactive Protein Gen 3 assay is a particle enhanced turbidimetric assay. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically at 570 nm.
Here's a breakdown of the acceptance criteria and study information for the Tina-Quant C-Reactive Protein Gen. 3 device, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes modifications to an existing device (Tina-Quant C-Reactive Protein Gen 3) and claims substantial equivalence to its predicate device (Tina-Quant C-Reactive Protein (Latex), K032336). Therefore, the acceptance criteria are implicitly defined by demonstrating comparable core performance characteristics to the predicate device. The information below presents the modified device's performance alongside the predicate's performance for comparison, which serves as the "acceptance criteria" through the lens of substantial equivalence.
Table of Acceptance Criteria (Predicate Performance) and Reported Device Performance (Modified Device)
| Feature | Acceptance Criteria (Predicate Device Performance - K032336) | Reported Device Performance (Modified Device - K082444) |
|---|---|---|
| Measuring Range | Roche/Hitachi 902: 1-265 mg/L | |
| Roche/Hitachi 717/Modular D: 1-265 mg/L, 1-398 mg/L with rerun | ||
| Roche/Hitachi 904/911/912: 1-260 mg/L, 1-520 mg/L with rerun | ||
| Roche/Hitachi 917/Modular P: 1-280 mg/L, 1-560 mg/L with rerun | Roche/Hitachi 901/912/917/Modular P/Modular D analyzers: 0.3-350 mg/L. Dilution of samples via the rerun function is a 1:2 dilution. | |
| Precision (Within Run) | Control 1: Mean (mg/L) 3.36, SD (mg/L) 0.09, %CV 2.76 | |
| Control 2: Mean (mg/L) 22.17, SD (mg/L) 0.44, %CV 1.96 | ||
| Control 3: Mean (mg/L) 51.12, SD (mg/L) 0.90, %CV 1.77 | ||
| H Pool 1: Mean (mg/L) 5.76, SD (mg/L) 0.14, %CV 2.50 | ||
| H Pool 2: Mean (mg/L) 150.15, SD (mg/L) 1.14, %CV 0.76 | Control 1: Mean (mg/L) 3.6, SD (mg/L) 0.03, %CV 0.85 | |
| Control 2: Mean (mg/L) 42.2, SD (mg/L) 0.26, %CV 0.61 | ||
| H Pool 1: Mean (mg/L) 0.9, SD (mg/L) 0.03, %CV 4.00 | ||
| H Pool 2: Mean (mg/L) 1.6, SD (mg/L) 0.02, %CV 1.02 | ||
| H Pool 3: Mean (mg/L) 18.4, SD (mg/L) 0.09, %CV 0.48 | ||
| Precision (Between Run) | Control 1: Mean (mg/L) 3.51, SD (mg/L) 0.16, %CV 4.61 | |
| Control 2: Mean (mg/L) 22.01, SD (mg/L) 0.62, %CV 2.81 | ||
| Control 3: Mean (mg/L) 50.41, SD (mg/L) 0.94, %CV 1.86 | ||
| H Pool 1: Mean (mg/L) 5.99, SD (mg/L) 0.15, %CV 2.53 | ||
| H Pool 2: Mean (mg/L) 146.31, SD (mg/L) 2.63, %CV 1.80 | Control 1: Mean (mg/L) 3.1, SD (mg/L) 0.08, %CV 2.7 | |
| Control 2: Mean (mg/L) 41.4, SD (mg/L) 0.86, %CV 2.1 | ||
| H Pool 1: Mean (mg/L) 0.5, SD (mg/L) 0.03, %CV 6.2 | ||
| H Pool 2: Mean (mg/L) 1.5, SD (mg/L) 0.05, %CV 3.3 | ||
| H Pool 3: Mean (mg/L) 39.1, SD (mg/L) 0.73, %CV 1.9 | ||
| Analytical Sensitivity | Functional Sensitivity: 0.88 mg/L | |
| Lower Detection Limit: 0.425 mg/L | Limit of Quantitation (Functional Sensitivity): 0.6 mg/L | |
| LoB: 0.2 mg/L | ||
| LoD: 0.3 mg/L | ||
| Interferences | Icterus: No significant interference up to 60 mg/dL | |
| Hemolysis: No significant interference up to 950 mg/dL | ||
| Lipemia: No significant interference up to L index of 1700 | ||
| Rheumatoid Factor: No interference up to 1200 IU/mL | ||
| High dose hook effect: No false results up to CRP concentrations of 1200 mg/L | Icterus: same (implicitly up to 60 mg/dL) | |
| Hemolysis: No significant interference up to 1000 mg/dL | ||
| Lipemia: No significant interference up to L index of 1000 | ||
| Rheumatoid Factor: same (implicitly up to 1200 IU/mL) | ||
| High dose hook effect: same (implicitly up to 1200 mg/L) | ||
| Method Comparison | Slope (Passing Bablok): 1.020 | |
| Intercept: 0.000 | ||
| Coefficients of correlation (r): 1.000 | Comparison was performed against Tina-Quant C-Reactive Protein (latex) on Hitachi 917. Specific numerical results (slope, intercept, correlation coefficient) for the modified device against the predicate are not provided in this section, but the predicate's values are listed as the reference, implying the modified device aims to match these. |
Study Information
The provided document describes a Special 510(k): Device Modification submission for the Tina-Quant C-Reactive Protein Gen 3 assay. The core of the "study" is a comparison of the modified device's performance characteristics against its predicate device (Tina-Quant C-Reactive Protein (Latex), K032336), to demonstrate substantial equivalence.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the specific number of samples used for each test (e.g., precision, interference, method comparison). For the "Method Comparison," it refers to a "Scatter plot showing correlation between two methods for measuring C-Reactive Protein," which implies a collection of patient or control samples were run on both methods. However, the exact count is not given.
- Data Provenance: Not explicitly stated. The studies were conducted by Roche Diagnostics, suggesting internal studies. The country of origin of the data is not mentioned, nor is whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an in vitro diagnostic (IVD) device for quantitative determination of CRP. For such devices, "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by expert consensus on interpretations like with imaging. The document traces the device's standardization to CRM 470, which is a certified reference material for proteins. There is no mention of experts establishing a ground truth in the context of clinical interpretation, as this device provides a quantitative measurement.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is an IVD device for quantitative measurement. Adjudication methods like "2+1" typically apply to diagnostic tasks involving human interpretation or subjective assessments, where disagreements between experts need to be resolved.
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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, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay, not a device that assists human readers (like AI for image analysis). Therefore, comparisons of human reader performance with or without AI assistance are not relevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively, this is a standalone device performance evaluation. The device is an automated clinical chemistry analyzer that quantitatively measures CRP. The performance metrics reported (precision, analytical sensitivity, interference, method comparison) are intrinsic to the device's analytical function without direct human intervention in the result generation process, beyond sample loading and general operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference material standardization. The device claims traceability to CRM 470 for standardization. This implies that the "ground truth" for the quantitative CRP measurements is established against this internationally recognized reference material, rather than clinical outcomes, pathology, or expert consensus on a diagnostic interpretation.
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The sample size for the training set:
- Not applicable. This document is for a device modification of an in vitro diagnostic assay, not an AI/ML algorithm. Therefore, there isn't a "training set" in the sense of data used to train a machine learning model. The assay's parameters would have been developed and optimized through laboratory experiments, but the concept of a "training set" as commonly understood in AI/ML is not directly relevant here.
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How the ground truth for the training set was established:
- Not applicable. As explained above, there is no "training set" for an AI/ML algorithm. For the initial development and optimization of the assay reagents and methods, ground truth for measuring CRP would typically be established using highly characterized samples with known CRP concentrations (e.g., purified CRP, reference materials like CRM 470, or validated high-accuracy laboratory methods).
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(48 days)
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
The CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.
The CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the quantitative measurement of C-reactive protein in human serum or plasma. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically. The calibrator is the Calibrator for automated systems (C.f.a.s). Proteins; and the recommended control materials are CRP T Control N and Precinorm Protein.
Here's a breakdown of the acceptance criteria and study information for the C-Reactive Protein (Latex) High Sensitive Test System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary presents a comparison study to predicate devices rather than explicit acceptance criteria with pre-defined thresholds. The device aims to demonstrate "substantial equivalence" to the predicate devices. Therefore, the "acceptance criteria" here are implied to be performance characteristics that are comparable to or better than the predicate devices.
| Characteristic | Predicate Device (Tina-Quant® CRP (Latex) HS (K042485)) Reported Performance | Predicate Device (Dade-Behring N High Sensitivity CRP (K033908)) Reported Performance | New Device (CRP (Latex) HS for COBAS Integra instruments) Reported Performance | Implied Acceptance Criteria (Demonstrate equivalence/comparability) |
|---|---|---|---|---|
| Intended Use | Quantitative determination of CRP in human serum/plasma for inflammatory/infection/tissue injury, and aid in CHD risk assessment. | Quantitative determination of CRP in human serum/heparin/EDTA plasma using immunonephelometry for infection/tissue injury/inflammatory disorders, and aid in CVD risk assessment. Also independent marker for recurrent events in stable CAD or ACS. | Same as K042485 | Same intended use as predicate devices. |
| Assay Principle | Latex particle-enhanced immunoturbidimetric test | Particle-enhanced agglutination with nephelometric detection | Same as K042485 (Latex particle-enhanced immunoturbidimetric test) | Consistent assay principle with a predicate (K042485 in this case). |
| Instrument | Roche/Hitachi family of analyzers | Dade-Behring BN Systems (nephelometric systems) | COBAS Integra family of analyzers (Integra 400/ 700/ 800) | Compatible with specified COBAS Integra instruments. |
| Reagent Stability | Unopened: up to expiration date at 2-8 °C. On board: 90 days. | Unopened: up to expiration date at 2-8 °C. Opened: 4 weeks in closed vial. | Unopened: up to expiration date at 2-8 °C. On board: 12 weeks. | Comparable or improved reagent stability. |
| Reagent Composition | R1: TRIS buffer, BSA, immunoglobulins (mouse), preservative, stabilizers. R2: Latex particles coated with anti-CRP (mouse) in glycine buffer, preservatives, stabilizers. | Suspension of polystyrene particles coated with mouse monoclonal antibodies to CRP; preservatives. | Same active ingredients and antibody as K042485 | Similar reagent components to a predicate. |
| Sample Type | Human serum and plasma | Human serum, and heparin and EDTA plasma | Same as K042485 (Human serum and plasma) | Compatible with human serum and plasma. |
| Traceability/Standardization | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | Standardized to Tina-Quant® CRP (Latex) HS which is standardized to reference prep CRM 470 (RPPHS 91/0619) | Standardized to recognized reference material. |
| Measuring Range | 0.1 – 20 mg/L without dilution. 0.1 – 300 mg/L with dilution and rerun. | 0.175 – 1100 mg/L with dilution | 0-20 mg/L without dilution. 0-300 mg/L with postdilution. | Comparable or improved measuring range. |
| Lower Detection Limit | 0.03 mg/L | 0.175 mg/L | 0.1 mg/L | Comparable or improved lower detection limit. |
| Within-run Precision (%CV) | Control: 0.43% at 4.27 mg/L, 0.41% at 11.62 mg/L. Serum: 1.34% at 0.55 mg/L, 0.28% at 12.36 mg/L. | Control: 2.5% at 0.5 mg/L, 3.8% at 1.3 mg/L, 2.1% at 2.1 mg/L, 2.6% at 14 mg/L, 3.9% at 24 mg/L, 5.7% at 56 mg/L. | Control: 0.9% at 3.3 mg/L, 0.7% at 8.0 mg/L. Serum: 1.3% at 1.6 mg/L, 0.6% at 11.4 mg/L. | Comparable or improved within-run precision. |
| Between-run Precision (%CV) | Control: 2.70% at 4.34 mg/L, 3.45% at 11.90 mg/L. Serum: 5.70% at 0.52 mg/L, 2.51% at 10.98 mg/L. | Control: 3.1% at 0.5 mg/L, 3.8% at 1.1 mg/L, 3.4% at 2.1 mg/L, 4.0% at 15 mg/L, 2.3% at 26 mg/L, 4.4% at 62 mg/L. | Control: 3.5% at 3.3 mg/L, 2.2% at 8.0 mg/L. Serum: 3.1% at 1.5 mg/L, 2.3% at 11.4 mg/L. | Comparable or improved between-run precision. |
| Functional Sensitivity (CV 5mg/L), Rheumatoid factors |
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(46 days)
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
The Tina-quant® CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.
The Tina-quant® CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the measurement of C-reactive protein in human serum or plasma.
The provided submission describes an in vitro diagnostic device (IVD) for measuring C-reactive protein (CRP), the "Tina-Quant® CRP (Latex) HS Test System." This is a Class II device and the submission seeks substantial equivalence to existing devices. Therefore, the information provided focuses on comparing the new device's specifications and performance to its predicates, rather than presenting a novel clinical study with independent acceptance criteria for a new type of device.
Here's an analysis based on the provided text, addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of a specified threshold that the device needed to meet in a new clinical study. Instead, it demonstrates substantial equivalence by comparing the performance characteristics of the new device against its predicate devices. The implicit acceptance criterion is that the performance characteristics of the new device should be comparable or equivalent to the predicate devices.
| Characteristic | Tina-Quant® CRP (Latex) HS (modified intended use) | Predicate Device Tina-Quant® CRP (Latex) HS (K003400) | Predicate Device Dade-Behring N High Sensitivity CRP (K033908) |
|---|---|---|---|
| Intended Use | Extended to include assessment of CAD risk and recurrent event prognosis in ACS/stable CAD. | Quantitative determination of CRP in human serum/plasma for inflammatory disorders. | Quantitative determination of CRP in human serum/plasma for inflammatory disorders, CAD risk, and recurrent event prognosis in ACS/stable CAD. |
| Assay Principle | Same as K003400 (Latex particle-enhanced immunoturbidimetric test) | Latex particle-enhanced immunoturbidimetric test | Particle-enhanced agglutination with nephelometric detection |
| Instrument | Same as K003400 (Roche/Hitachi family of analyzers) | Roche/Hitachi family of analyzers | Dade-Behring BN Systems (nephelometric systems) |
| Reagent Stability | Same as K003400 (Unopened: up to stated expiration date at 2-8°C; On board: 90 days) | Unopened: up to stated expiration date at 2-8°C; On board: 90 days | Unopened: up to stated expiration date at 2-8°C; Opened: 4 weeks |
| Sample Type | Same as K003400 (Human serum and plasma) | Human serum and plasma | Human serum, and heparin and EDTA plasma |
| Traceability/Standardization | Same as both predicates (IFCC/BCR/CAP reference preparation CRM 470) | IFCC/BCR/CAP reference preparation CRM 470 | IFCC/BCR/CAP reference preparation CRM 470 |
| Measuring Range | Same as K003400 (0.1 – 20 mg/L without dilution, 0.1 - 300 mg/L with dilution) | 0.1 – 20 mg/L without dilution, 0.1 - 300 mg/L with dilution | 0.175 – 1100 mg/L with dilution |
| Lower Detection Limit | Same as K003400 (0.03 mg/L) | 0.03 mg/L | 0.175 mg/L |
| Within-run precision (%CV) | Same as K003400 | Control: 0.43% (4.27 mg/L), 0.41% (11.62 mg/L); Human serum: 1.34% (0.55 mg/L), 0.28% (12.36 mg/L) | 2.5% (0.5 mg/L), 3.8% (1.3 mg/L), 2.1% (2.1 mg/L), etc. |
| Between-run precision (%CV) | Same as K003400 | Control: 2.70% (4.34 mg/L), 3.45% (11.90 mg/L); Human serum: 5.70% (0.52 mg/L), 2.51% (10.98 mg/L) | 3.1% (0.5 mg/L), 3.8% (1.1 mg/L), 3.4% (2.1 mg/L), etc. |
| **Functional Sensitivity (CV 5mg/L); RF |
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