Who is the manufacturer of C-REACTIVE PROTEIN (LATEX)?

Roche Diagnostics Corp. filed the 510(k) submission for C-REACTIVE PROTEIN (LATEX) (K083444).

What is the FDA product code for C-REACTIVE PROTEIN (LATEX)?

DCN. It is classified under 21 CFR 866.5270 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for C-REACTIVE PROTEIN (LATEX)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for C-REACTIVE PROTEIN (LATEX)?

Tina-Quant C-Reactive Protein (Latex) (K032336).

Who can help prepare an FDA 510(k) submission like C-REACTIVE PROTEIN (LATEX)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

C-REACTIVE PROTEIN (LATEX)

K083444 · Roche Diagnostics Corp. · DCN · Mar 18, 2009 · Immunology

Device Facts

Record ID	K083444
Device Name	C-REACTIVE PROTEIN (LATEX)
Applicant	Roche Diagnostics Corp.
Product Code	DCN · Immunology
Decision Date	Mar 18, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5270
Device Class	Class 2

Intended Use

Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.

Device Story

Tina-Quant C-Reactive Protein Gen 3 is a particle-enhanced turbidimetric assay for quantitative CRP measurement in human serum and plasma. The device utilizes latex particles coated with monoclonal anti-CRP antibodies; human CRP in the sample causes agglutination of these particles. The resulting precipitate is measured turbidimetrically at 570 nm on Roche automated clinical chemistry analyzers. The assay is operated by laboratory technicians in clinical settings. Output is a quantitative CRP concentration (mg/L), which healthcare providers use to assess tissue injury. The device provides an automated, standardized method for CRP quantification, facilitating clinical decision-making regarding inflammatory states and tissue damage.

Clinical Evidence

Bench testing only. Precision studies demonstrated within-run CVs of 0.48-4.00% and between-run CVs of 1.9-6.2%. Analytical sensitivity reported as LoB 0.2 mg/L, LoD 0.3 mg/L, and functional sensitivity 0.6 mg/L. Method comparison against the predicate device on the Hitachi 917 analyzer showed a slope of 1.020, intercept of 0.000, and correlation coefficient (r) of 1.000. Interference testing confirmed no significant impact from hemolysis (up to 1000 mg/dL), lipemia (L index 1000), or icterus.

Technological Characteristics

Particle-enhanced turbidimetric assay. Reagents: latex particles coated with monoclonal anti-CRP antibodies. Detection: turbidimetric measurement at 570 nm. Platform: Roche/Hitachi automated clinical chemistry analyzers. Measuring range: 0.3-350 mg/L. Sample types: serum, Li-heparin plasma, K2/K3-EDTA plasma. Calibration: automated, required after reagent lot change or QC failure. Traceability: CRM 470.

Indications for Use

Indicated for the measurement of C-reactive protein to aid in the evaluation of the amount of injury to body tissues in patients requiring clinical chemistry analysis.

Regulatory Classification

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.

Predicate Devices

Tina-Quant C-Reactive Protein (Latex) (K032336)

Related Devices

K032336 — TINA-QUANT CRP (LATEX) · Roche Diagnostics Corp. · Aug 5, 2003
K192072 — Tina-quant C-Reactive Protein IV · Roche Diagnostics Operations (Rdo) · Feb 21, 2020
K042485 — TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) · Roche Diagnostics Corp. · Oct 29, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ · MAR I 8 2009 K082444 ## 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 <0.2 mg/L. - Modification to the insert to clarify when calibration is required. Modifications prompting this filing include: - The reagent composition for R2 was modified. - LOB and LOD values were determined and reported in the insert. - The functional sensitivity was modified. - The measuring range for the Roche/Hitachi clinical chemistry analyzers was harmonized to 0.3-350 mg/L. - The Interference with Hemolysis and Lipemia were modified. - Only standard anticoagulants were tested and claimed; Na-heparin and Na2 EDTA were not mentioned in the insert. {1}------------------------------------------------ | Submission History | The Tina-Quant C-Reactive Protein assay was originally cleared in K003400. In K032336, the following device modifications were cleared: Broadening the measuring range of the assay Increasing the R1 buffer concentration Deleting citrated plasma and adding K2-EDTA as acceptable specimen types Changing the name of the assay to TQ CRP (latex) | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Proprietary name: Tina-Quant C-Reactive Protein Gen 3 | | And | Common name: CRPL3 | | Classification | Classification name: C-Reactive Protein Immunological Test System Product code: DCN Regulation Citation: 866.5270 Panel: 82 Immunology Class II | | Establishment Registration | The establishment registration number for Roche Diagnostics GmbH Penzberg is 9610126. | | 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. | | Intended use | Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers. | | Substantial equivalence | The Roche Tina-Quant C-Reactive Protein Gen. 3 is substantially equivalent to the Roche Tina-Quant C-Reactive Protein (Latex) (CRPLX) cleared in K032336. | : - . : {2}------------------------------------------------ . Substantial equivalence – | Feature | Modified Device : Tina-Quant C- Reactive Protein Gen 3 | Predicate Device: Tina-Quant C- Reactive Protein (Latex) (K032336) | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers. | Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on automated clinical chemistry analyzers. | | Sample Type | Serum Plasma: Li-heparin, K2-/K3-EDTA plasma | Serum Plasma: Li-/Na-heparin, Na-/K3- EDTA, citrate plasma | | Instrument Platform | Roche/Hitachi family including H902, H912, H917, Mod P and Mod D. (See section 4 (Other Supportive Information) for additional information on application to the cobas c501 and c311 clinical chemistry analyzers.) | Roche/Hitachi family including H902, H911, H912, H917, Mod P and Mod D. | | Calibrator | Same | PresiSet Serum Proteins and CFAS Proteins | | Calibration frequency | After entering new calibrator values, after reagent lot change and as required following quality control procedures | After reagent lot change and as required following quality control procedures | | Controls | Same | CRP T Control N, Precinorm Protein, Precipath Protein | | Traceability | Same | Standardized against CRM 470 | | Reagent Stability | Same | • Up to expiration at 2-8 deg C • R1/R2: 84 days opened and refrigerated on the analyzer | : . . : {3}------------------------------------------------ | Measuring Range | Roche/Hitachi 901/912/917/Modular P/Modular D analyzers: 0.3-350 mg/L Dilution of samples via the rerun function is a 1:2 dilution. | | | | 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 | | | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------|------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------|------| | Precision | Within Run: | | | | Within Run: | | | | | | Sample | Mean (mg.L) | SD (mg/L) | %CV | Sample | Mean (mg.L) | SD (mg/L) | %CV | | | Control 1 | 3.6 | 0.03 | 0.85 | Control 1 | 3.36 | 0.09 | 2.76 | | | Control 2 | 42.2 | 0.26 | 0.61 | Control 2 | 22.17 | 0.44 | 1.96 | | | H Pool 1 | 0.9 | 0.03 | 4.00 | Control 3 | 51.12 | 0.90 | 1.77 | | | H Pool 2 | 1.6 | 0.02 | 1.02 | H Pool 1 | 5.76 | 0.14 | 2.50 | | | H Pool 3 | 18.4 | 0.09 | 0.48 | H Pool 2 | 150.15 | 1.14 | 0.76 | | | Between Run: | | | | Between Run: | | | | | | Sample | Mean (mg.L) | SD (mg/L) | %CV | Sample | Mean (mg.L) | SD (mg/L) | %CV | | | Control 1 | 3.1 | 0.08 | 2.7 | Control 1 | 3.51 | 0.16 | 4.61 | | | Control 2 | 41.4 | 0.86 | 2.1 | Control 2 | 22.01 | 0.62 | 2.81 | | | H Pool 1 | 0.5 | 0.03 | 6.2 | Control 3 | 50.41 | 0.94 | 1.86 | | | H Pool 2 | 1.5 | 0.05 | 3.3 | H Pool 1 | 5.99 | 0.15 | 2.53 | | | H Pool 3 | 39.1 | 0.73 | 1.9 | H Pool 2 | 146.31 | 2.63 | 1.80 | | Analytical Sensitivity | Limit of Quantitation (Functional Sensitivity): 0.6 mg/L LoB: 0.2 mg/L LoD: 0.3 mg/L | | | | Functional Sensitivity: 0.88 mg/L | | | | | Analytical Specificity | Not Claimed | | | | Lower Detection Limit: 0.425 mg/L | | | | · . : · {4}------------------------------------------------ ﻟﻠ . | Interferences | | | |-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | | Icterus: same | Icterus: No significant interference up to 60 mg/dL | | | Hemolysis: No significant interference up to 1000 mg/dL | Hemolysis: No significant interference up to 950 mg/dL | | | Lipemia: No significant interference up to L index of 1000 | Lipemia: No significant interference up to L index of 1700 | | | Rheumatoid Factor: same | Rheumatoid Factor: No interference up to 1200 IU/mL | | | High does hook effect: same | High does hook effect: No false results up to CRP concentrations of 1200 mg/L | | Expected Values | same | <5.0 mg/L | | 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 | | Image: Scatter plot showing correlation between two methods for measuring C-Reactive Protein. | | | {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAR 1 8 2009 Roche Diagnostics Corp. c/o Ms. Kathie J. Goodwin Regulatory Affairs Consultant 9115 Hague Rd., P.O. Box 50416 Indianapolis, Indiana 46250-0416 Re: k083444 Trade/Device Name: Tina-Quant C-Reactive Protein (Latex) Gen. 3 Regulation Number: 21 CFR 866.5270 Regulation Name: C- reactive protein immunological test system Regulatory Class: II Product Code: DCN Dated: January 26, 2009 Received: February 2, 2009 Dear Ms. Goodwin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register. {6}------------------------------------------------ Page 2- Ms. Goodwin Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240- 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For question regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. You many obtain other general information on your responsibilities under the Act from the Division of Small Manufactuers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Maria M. Chan Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indication for Use 510(k) Number (if known): Device Name: Tina-Quant C-Reactive Protein (Latex) Gen. 3 Indication For Use: Measurement of c-reactive protein aids in the evaluation of the amount of injury to body tissues. × Prescription Use _ (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) Division Signoff Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K083444