(46 days)
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 |
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).