(7 days)
Not Found
No
The description details a standard immunoturbidimetric assay and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is an in vitro diagnostic (IVD) assay designed to quantitatively determine CRP levels, which aids in evaluating body tissue injury. It does not directly treat or prevent a disease, injury, or condition in a patient, which is the function of a therapeutic device.
Yes
The device measures C-reactive protein to aid in evaluating body tissue injury, which is a diagnostic purpose.
No
The device description clearly states it is a particle-enhanced immunoturbidimetric assay involving latex microparticles and antigen/antibody complex formation, which are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoturbidimetric 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.
- Sample Type: It analyzes human serum and plasma, which are biological samples taken from the body.
- Measurement: It performs a quantitative determination of CRP, a substance found in these biological samples.
- Device Description: The description details a laboratory-based assay using reagents and a measurement technique (turbidimetry) to analyze the sample.
- Predicate Device: The mention of a predicate device with a K number (K003400) indicates that this device has gone through a regulatory process for medical devices, specifically IVDs in this context.
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
DCN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary - Tina-quant CRP (Latex)
| 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 Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831
Contact person: Sherri L. Coenen
Date prepared: July 25, 2003 |
| Device Name | Proprietary name: Roche Diagnostics Tina-quant CRP (Latex) |
| | Common name: Tina-quant CRP (Latex) |
| | Classification name: C-reactive protein immunological test system |
| Device
description | 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. |
| Intended use | Immunoturbidimetric assay for the in vitro quantitative determination of CRP
in human serum and plasma on automated clinical chemistry analyzers. |
| Predicate
Device | We claim substantial equivalence to the currently marketed Roche
Diagnostics Tina-quant CRP (Latex) HS assay. (K003400). |
24
1
510(k) Summary - COBAS Integra Creatinine plus ver.2,
continued
The following table describes the similarities and differences between the Reagent : Summary Tina-quant CRP (Latex) and the predicate device.
| Topic | Tina-quant CRP (Latex) HS
(K003400) | Tina-quant CRP (Latex)
(Modified Device) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the in
vitro quantitative determination of
CRP in human serum and plasma on
automated clinical chemistry
analyzers. | Same |
| Method | Particle-enhanced
immunoturbidimetric assay | Same |
| Sample type | Serum
Plasma: Li-/Na-heparin, Na-/K3-
EDTA, citrate plasma | Serum
Plasma: Li-/Na-heparin, Na-/K2-/K3-
EDTA |
| Measuring
range | Roche/Hitachi 902:
0.1 - 20 mg/L Roche/Hitachi
904/911/912/917/Modular P:
0.2 - 20 mg/L
0.1 - 300 mg/L with rerun | 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 |
| Expected
values |