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510(k) Data Aggregation
(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 < 10%) | Same as K003400 (0.11 mg/L) | 0.11 mg/L | Not available |
| Limitations/Interferences | Same as K003400 (No interference from high bilirubin, hemoglobin, triglycerides; specific L index values) | No interference from Bilirubin up to 230 mg/L, Hemoglobin up to 36 g/L, Triglycerides up to 7.4 g/L; Highly lipemic samples must not be tested. | No significant interference up to I index of 60, H index of 1000, L index of 1000 (at CRP > 5mg/L); RF < 1200 IU/mL; No high dose hook effect up to 1000 mg/L. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific "test set" sample sizes or data provenance (country of origin, retrospective/prospective) in the context of a new clinical performance study for the modified device. Instead, it refers to the performance characteristics being "Same as K003400" or derived from studies supporting the predicate devices. The data presented for precision (within-run, between-run) are typically derived from internal laboratory studies using control materials and human serum/plasma, rather than a broad patient test set for the intended use claims.
For precision, the numbers of samples/replicates are not specified, but typically these studies use multiple replicates of control materials and patient samples across several runs to establish these coefficients of variation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given this is an IVD for quantitative measurement of a biomarker, "ground truth" is typically established by reference methods or validated laboratory measurements rather than expert consensus on diagnostic images or clinical assessments. The submission refers to "IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619)" for traceability/standardization, which is the ground truth for calibration and accuracy. There is no mention of human experts defining ground truth for performance evaluation in this type of submission.
4. Adjudication Method for the Test Set
Not applicable as this is an IVD measuring a biomarker. Adjudication methods are typically used in clinical trials or imaging studies where subjective interpretation or complex clinical outcomes require consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance
Not applicable. This device is not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. It is a laboratory assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. This is a laboratory diagnostic assay, not an algorithm or AI system. The performance presented is inherently "standalone" in the sense that it measures the device's analytical performance on its own.
7. The Type of Ground Truth Used
The ground truth for the quantitative measurement of CRP is established by reference materials and standardization protocols, specifically "IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619)". This ensures that the CRP measurements are accurate and comparable across different laboratories and devices, aligning with established scientific standards for the analyte.
8. The Sample Size for the Training Set
Not applicable in the context of this device. A "training set" is relevant for machine learning algorithms or AI models. For an IVD like the Tina-Quant CRP assay, performance is established through analytical validation studies (e.g., precision, accuracy, linearity, detection limits, interference) using a variety of human samples (serum, plasma) and control materials. The number of samples used for these analytical studies is not explicitly quantified as a "training set" in the provided K042485 summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable for a non-AI IVD. The calibration and analytical accuracy are established against the aforementioned international reference standard (IFCC/BCR/CAP reference preparation CRM 470).
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