(117 days)
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No
The description details a standard immunoturbidimetric assay and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic assay used to measure C-Reactive Protein, aiding in the evaluation of tissue injury. It does not directly provide therapy or treatment.
Yes
The device is an "immunoturbidometric assay" intended for the "in vitro quantitative determination of CRP in human serum and plasma." The measurement of C-reactive protein "aids in the evaluation of the amount of injury to body tissues," which is a diagnostic purpose.
No
The device description clearly states it is a "particle enhanced turbidimetric assay" and involves "latex particles coated with monoclonal anti-CRP antibodies" and "precipitate is determined turbidimetrically at 570 nm." This indicates a physical assay and measurement process, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma". The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory test performed on biological samples (serum and plasma) using a chemical reaction (agglutination with latex particles) and a measurement technique (turbidimetry). This is characteristic of an IVD.
- Measurement of Biomarker: The device measures C-reactive protein (CRP), a biomarker in human samples, to aid in the evaluation of tissue injury. This is a typical function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: Tina-Quant C-Reactive Protein Gen 3 on Hitachi 917 compared to Tina-Quant C-Reactive Protein (latex) on Hitachi 917
Slope (Passing Bablok): 1.020
Intercept: 0.000
Coefficients of correlation (r): 1.000
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Within Run:
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
Between Run:
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:
Limit of Quantitation (Functional Sensitivity): 0.6 mg/L
LoB: 0.2 mg/L
LoD: 0.3 mg/L
Interferences:
Icterus: same
Hemolysis: No significant interference up to 1000 mg/dL
Lipemia: No significant interference up to L index of 1000
Rheumatoid Factor: same
High does hook effect: same
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
· MAR I 8 2009
510(k) Summary – Tina-Quant C-Reactive Protein Gen. 3
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 521 - 3723 |
Contact Person: Kathie J. Goodwin
Date Prepared: November 17th, 2008 |
| Submission Purpose | Roche Diagnostics hereby submits this Special 510(k): Device Modification to provide notification of modifications to our Tina-Quant C-Reactive Protein Gen 3 assay. This assay was most recently cleared for use in K032336 on the Roche/Hitachi Clinical Chemistry analyzers. |
Since the K032336 filing, modifications to the CRPL3 assay on the Roche/Hitachi clinical chemistry analyzers include:
- The Interference section of the insert was modified regarding potential HAMA interference.
- The lower detection limit was added to the measuring range section in the package insert according to the product specification of