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510(k) Data Aggregation
(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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(7 days)
TINA-QUANT CRP (LATEX)
Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on automated clinical chemistry analyzers.
Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
The Tina-quant CRP (Latex) is a particle-enhanced immunoturbidimetric assay. Anti-CRP antibodies coupled to latex microparticles react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
The provided text is a 510(k) summary for the Tina-quant CRP (Latex) device. It describes the device's intended use, method, and comparison to a predicate device. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The document is a regulatory submission for substantial equivalence to an existing device, and as such, it focuses on demonstrating that the new device is as safe and effective as the predicate device. It highlights similarities in intended use and methodology but also notes differences in measuring range and allowable plasma types. Crucially, it does not provide data from specific studies demonstrating performance against acceptance criteria.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary.
- Sample sizes used for the test set and the data provenance: Not detailed in the provided text.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not detailed in the provided text.
- Adjudication method for the test set: Not detailed in the provided text.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, including effect size: Not detailed in the provided text. This type of study is more common for diagnostic imaging AI, not for a quantitative immunoassay like this.
- If a standalone performance study was done: The document describes the device itself but doesn't provide details on specific performance studies (like accuracy, precision, or linearity studies that would typically be performed).
- The type of ground truth used: Not detailed in the provided text.
- The sample size for the training set: Not applicable as this is a chemical assay, not an AI/machine learning device that requires a "training set" in the conventional sense.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
The 510(k) summary focuses on establishing "substantial equivalence" to a predicate device (Roche Diagnostics Tina-quant CRP (Latex) HS assay, K003400) by comparing attributes like intended use, method, sample type, and measuring range. It explains that the modified device has an expanded measuring range compared to the predicate. The FDA's letter (pages 2-3) confirms the substantial equivalence determination but does not delve into the specific performance study details you are asking for.
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