ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

K040431 · Roche Diagnostics Corp. · DAO · Mar 10, 2004 · Immunology

Device Facts

• Record ID: K040431
• Device Name: ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
• Applicant: Roche Diagnostics Corp.
• Product Code: DAO · Immunology
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Device Story

Tina-quant IgM Gen.2 is an in vitro diagnostic reagent assay for quantitative IgM measurement in human serum/plasma. Modification of previously cleared Tina-quant IgM (K955908) to reduce hook effect and lipemic sample interference. Reagent formulation changes; addition of sensitive application for low-end measuring range (4-150 mg/dL); updated pediatric reference ranges (0-19 years). Operates on Roche/Hitachi 902, 904, 911, 912, 917, and Modular analyzers. Used in clinical laboratory settings by technicians. Output is quantitative IgM concentration (mg/dL). Results assist clinicians in diagnosing/monitoring immune deficiency states, protein-losing conditions, and burns.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance characteristics, including measuring range comparisons and expected value ranges for adults and children.

Technological Characteristics

Immunoturbidimetric assay; utilizes anti-IgM antibodies. Designed for use on Roche automated clinical chemistry analyzers. Provides standard and sensitive application measuring ranges. No specific materials, energy sources, or software algorithm details provided beyond standard automated clinical chemistry instrumentation requirements.

Indications for Use

Indicated for the quantitative in vitro determination of IgM in human serum and plasma to aid in the diagnosis of abnormal protein metabolism and immune deficiency. For use on Roche automated clinical chemistry analyzers.

Regulatory Classification

Identification

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Predicate Devices

• Tina-quant IgM (K955908)

Submission Summary (Full Text)

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MAR 1 0 2904

K040431

## 510(k) Summary - Tina-quant IgM Gen.2

| 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<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] | |
| | Contact person: Sherri L. Coenen | |
| | Date prepared: February 17, 2004 | |
| Device Name | Proprietary name: Roche Diagnostics Tina-quant IgM Gen.2 | |
| | Common name: Tina-quant IgM Gen.2 | |
| | Classification name: IgM (Mu chain specific) antigen, antiserum, control | |
| Device<br>description | The Tina-quant IgM Gen.2 is an immunoturbidimetric assay. Anti-IgM<br>antibodies react with antigen in the sample to form an antigen/antibody<br>complex which is measured turbidimetrically. | |
| Intended use | Immunoturbidimetric assay for the quantitative in vitro determination of IgM<br>in human serum and plasma on Roche automated clinical chemistry<br>analyzers. | |
| Predicate<br>Device | We claim substantial equivalence to the currently marketed Roche<br>Diagnostics Tina-quant IgM assay. (K955908). | |

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## 510(k) Summary - Tina-quant IgM Gen.2, continued

Reagent Summary The following table describes the similarities and differences between the Tina-quant IgM Gen.2 and the predicate device.

| Topic | Tina-quant IgM<br>(K955908) | Tina-quant IgM Gen.2<br>(Modified Device) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the<br>quantitative in vitro determination of<br>IgM in human serum and plasma on<br>automated clinical chemistry<br>analyzers. | Same |
| Method | Immunoturbidimetric assay | Same |
| Sample type | Serum<br>Plasma: Heparin, EDTA | Same |
| Measuring<br>range | Roche/Hitachi 902:<br>30 - 490 mg/dL<br>Roche/Hitachi<br>904/911/912/917/Modular:<br>25 - 650 mg/dL<br>3 - 5362 mg/dL with rerun | Standard Application:<br>Roche/Hitachi 902:<br>25 - 650 mg/dL<br>Roche/Hitachi<br>904/911/912/917/Modular:<br>25 - 650 mg/dL<br>3 - 3660 mg/dL with rerun<br>Sensitive Application:<br>Roche/Hitachi 902:<br>4 - 150 mg/dL<br>Roche/Hitachi<br>904/911/912/917/Modular:<br>4 - 150 mg/dL<br>1 - 450 mg/dL with rerun |
| Expected<br>values | 40 - 230 mg/dL | Adults: 40 - 230 mg/dL<br>Additional ranges for children 0 - 19<br>years |

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MAR 1 0 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: k040431

Trade/Device Name: Roche Diagnostics Tina-quant IgM Gen.2 Regulation Number: 21 CFR § 866.5550 Regulation Name: Immunoglobulins (Light Chain Specific) Immunological Test System Regulatory Class: II Product Code: DAO Dated: February 17, 2004 Received: February 19, 2004

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). 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.

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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). You may obtain other general information on your responsibilities under the Act 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,

Joseph L. Arallett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices 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): 回线 KOYOY 3 |

Device Name: Tina-quant IgM Gen.2

Indications For Use:

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

Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

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

(Optional Format 1-2-96)

elan

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_KO40431 20