TINA-QUANT CRP (LATEX)

K032336 · Roche Diagnostics Corp. · DCN · Aug 5, 2003 · Immunology

Device Facts

• Record ID: K032336
• Device Name: TINA-QUANT CRP (LATEX)
• Applicant: Roche Diagnostics Corp.
• Product Code: DCN · Immunology
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended 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.

Device Story

Tina-quant CRP (Latex) is a particle-enhanced immunoturbidimetric assay used on automated clinical chemistry analyzers. Anti-CRP antibodies coupled to latex microparticles react with CRP antigen in human serum or plasma samples to form antigen/antibody complexes. The resulting turbidity is measured by the analyzer; the degree of turbidity is proportional to the CRP concentration in the sample. The device is intended for use by laboratory professionals in clinical settings. Results assist clinicians in evaluating the extent of tissue injury. The assay provides quantitative CRP levels, facilitating clinical decision-making regarding inflammatory or injury-related conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance comparisons between the subject device and the predicate, including measuring range verification and sample type compatibility.

Technological Characteristics

Particle-enhanced immunoturbidimetric assay; utilizes anti-CRP antibodies coupled to latex microparticles. Designed for use on automated clinical chemistry analyzers (e.g., Roche/Hitachi series). Measuring range varies by analyzer (e.g., 1-265 mg/L to 1-560 mg/L with rerun).

Indications for Use

Indicated for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma to aid in the evaluation of tissue injury.

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

• Roche Diagnostics Tina-quant CRP (Latex) HS assay (K003400)

Submission Summary (Full Text)

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# 510(k) Summary - Tina-quant CRP (Latex)

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>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<br>description | The Tina-quant CRP (Latex) is a particle-enhanced immunoturbidimetric<br>assay. Anti-CRP antibodies coupled to latex microparticles react with antigen<br>in the sample to form an antigen/antibody complex which is measured<br>turbidimetrically. |
| Intended use | Immunoturbidimetric assay for the in vitro quantitative determination of CRP<br>in human serum and plasma on automated clinical chemistry analyzers. |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed Roche<br>Diagnostics Tina-quant CRP (Latex) HS assay. (K003400). |

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## 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<br>(K003400) | Tina-quant CRP (Latex)<br>(Modified Device) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the in<br>vitro quantitative determination of<br>CRP in human serum and plasma on<br>automated clinical chemistry<br>analyzers. | Same |
| Method | Particle-enhanced<br>immunoturbidimetric assay | Same |
| Sample type | Serum<br>Plasma: Li-/Na-heparin, Na-/K3-<br>EDTA, citrate plasma | Serum<br>Plasma: Li-/Na-heparin, Na-/K2-/K3-<br>EDTA |
| Measuring<br>range | Roche/Hitachi 902:<br>0.1 - 20 mg/L Roche/Hitachi<br>904/911/912/917/Modular P:<br>0.2 - 20 mg/L<br>0.1 - 300 mg/L with rerun | Roche/Hitachi 902:<br>1 - 265 mg/L Roche/Hitachi 717/Modular D:<br>1 - 265 mg/L<br>1 - 398 mg/L with rerun Roche/Hitachi 904/911/912:<br>1 - 260 mg/L<br>1 - 520 mg/L with rerun Roche/Hitachi 917/Modular P:<br>1 - 280 mg/L<br>1 - 560 mg/L with rerun |
| Expected<br>values | < 0.5 mg/dl | Same |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." are arranged in a circular fashion around the caduceus symbol.

**AUG - 5 2003**

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sherri L Coenen, MT (ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

- Re: k032336
Trade/Device Name: Tina-quant CRP (Latex) Regulation Number: 21 CFR 866.5270 Regulation Name: C. reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: July 25, 2003 Received: July 29, 2003

Dear Ms. Coenen:

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 (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Tina-quant CRP (Latex)

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.

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Prescription Use (Per 21 CFR 801.109) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------------------------------|--------------------------------------------------------|
| OR | Over-The-Counter Use |

(Optional Format 1-2-96)

| Division Sign-Off | |
|------------------------------------------------------------|-----------------|
| | For Jean Cooper |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510(k) | K032336 |

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