TINA-QUANT IGG GEN.2

K050113 · Roche Diagnostics Corp. · DEW · Feb 8, 2005 · Immunology

Device Facts

• Record ID: K050113
• Device Name: TINA-QUANT IGG GEN.2
• Applicant: Roche Diagnostics Corp.
• Product Code: DEW · Immunology
• Decision Date: Feb 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma, and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers.

Device Story

Tina-Quant IgG Gen.2 is an in vitro diagnostic immunoturbidimetric assay; measures IgG concentration in human serum, plasma, and CSF samples. Operates on Roche automated clinical chemistry analyzers; anti-IgG antibodies react with sample antigen to form immune complexes; complex formation measured via turbidimetry. Provides quantitative IgG results to clinicians; aids diagnosis of abnormal protein metabolism and immune deficiency. Used in clinical laboratory settings by trained technicians. Results assist healthcare providers in assessing humoral immune status and patient ability to resist infection.

Clinical Evidence

Bench testing only. Precision evaluated over 21 days (CV 0.65-6.52%). Linearity established from 2-200 mg/L (extended to 1000 mg/L). Method comparison study (n=54) against predicate device showed strong correlation (r=0.988, slope=1.04). Interference testing confirmed no significant impact from hemolysis (up to 800 mg/dL hemoglobin) or icterus (up to 60 mg/dL bilirubin).

Technological Characteristics

Immunoturbidimetric assay; utilizes anti-IgG antibodies for antigen-antibody complex formation. Standardized to CRM 470. Designed for use on Roche/Hitachi automated clinical chemistry analyzers. Includes specific applications for serum/plasma and sensitive application for CSF. Reagent stability up to 90 days on-board refrigerated.

Indications for Use

Indicated for the quantitative determination of IgG in human serum, plasma, and cerebrospinal fluid (CSF) to aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) IgG assay on the BN II (k943997)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Theresa M. Ambrose, PhD 9115 Hague Rd. Indianapolis, IN 46250

2 2005 MAR

Re: k050113

Trade/Device Name: Tina-Quant IgG Gen.2 Regulation Number: 21 CFR 866.55 10 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test Regulatory Class: Class II Product Code: DEW Dated: January 14,2005 Received: January 18,2005

Dear Dr. Ambrose:

This letter corrects our substantially equivalent letter of February 8,2005 regarding the Tina-Quant IgG Gen.2 in which the dates for submission and receipt were incorrectly entered as January 4 and January 6,2005 respectively.

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 (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 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.

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

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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: registrationand listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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 continue 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert Beckerh.

Robert L. Becker, Jr., M.D., PhP 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

# 510(k) Number (if known):

Device Name: Tina-Ouant ® IgG Gen.2

Indications For Use:

Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers.

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

Prescription Use X AND/OR

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maria Chan
Division Sign-Off

office of in Viro Diagnostic Device Evaluation and Salely Page 1 of ____________________________________________________________________________________________________________________________________________________________________

STORE ...

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## 510(k) Summary

| 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<br>9115 Hague Road<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Theresa M. Ambrose |
| Device Name | Proprietary name: Tina-Quant® IgG Gen.2<br>Common name: Immunoglobulin G (IgG) Test<br>Classification name: IgG (gamma chain specific) antigen, antiserum, controls |
| Device Description | The Tina-Quant ® IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF. |
| Intended use | Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers.<br>Note: Serum and plasma cleared under K040434. |
| Indications for Use | Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. |

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### 510(k) Summary, Continued

The Tina-Quanta IgG Gen.2 test system is substantially equivalent to other Substantial equivalence devices legally marketed in the United States. We claim equivalence to in Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) IgG assay on the BN I1 cleared under K943997. Both products are intended for use in the quantitative determination of IgG in human CSF.

The following table compares the Tina-Quanta IgG Gen.2 test system with Substantial equivalence the predicate device. comparison

| Feature | Tina-Quant ® IgG Gen.2 | Dade-Behring N Antisera to Human Immunoglobulins IgG on BN II<br>(predicate) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical analyzers. | In vitro diagnostic reagents for the quantitative determination of immunoglobulims (IgG, IgA, and IgM) in human serum as well as of IgG in human urine and cerebrospinal fluid (CSF) using the BN systems. |
| Indication for Use | Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. | Quantitative determination of the immunoglobulins can provide important information on the humoral immune status. |
| Assay Protocol | Immunoturbidimetric assay | Immunochemical reaction with formation of immune complexes and measurement of scattered light intensity (nephelometric). |
| Traceability / Standardization | CRM 470 | CRM 470 |
| | | |
| Sample Types | Serum, plasma, CSF | Serum, plasma, urine, CSF |
| Reagent Stability | Unopened at 2-8°C: up to the<br>expiration date | Shelf life at 2-8°C : until<br>expiration date |
| | Opened and refrigerated on the<br>analyzer: 90 days | Opened, capped at 2-8°C: 4<br>weeks |
| | | On-board: 5 days at 8 hours<br>each or comparable period of<br>time (maximum 40 hours) |
| Controls | Sensitive application (CSF):<br>Precinorm PUC (Proteins in<br>Urine/CSF) / Precipath PUC | For IgG in urine or CSF:<br>N/T Protein Control LC<br>(human) |
| | Standard application (serum,<br>plasma) :Precinorm Protein /<br>Precipath Protein | |
| Calibrator | Sensitive application (CSF):<br>C.f.a.s. (Calibrator for automated<br>systems) PUC | N Proteins Standard SL<br>(human) |
| | Standard application (serum,<br>plasma) : C.f.a.s. Proteins | |
| Instrument | Roche/Hitachi family of<br>analyzers | BN Systems |
| Limitations | Carryover: to avoid carryover a<br>sample probe wash is<br>recommended. | Turbidity and particles in the<br>sample may interfere with<br>determination Samples<br>containing particles must be<br>centrifuged prior to testing. |
| | Icterus: no significant<br>interference up to an I index of<br>60 (60 mg/dL conjugated or<br>unconjugated bilirubin). | |
| | Falsely low results due to antigen<br>excess may occur above 1400<br>mg/L | |
| Ferformance Characteristics for CSF application | | |
| Measuring Range | 2 0 - 200 mg/L<br>2-1000 mg/L with rerun<br>(upper limits depend on highest<br>standard concentration) | Depends on concentration of<br>proteins in N Protein Standard<br>SL |
| Expected Values for IgG<br>in CSF | 10-30 mg/L (according to CRM<br>470 standardization) | Below 34 mg/L (with reference<br>to CRM 470_) |

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| Precision | | |
|------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Within-run CV | Intra-Assay CV |
| | 0.65% @ 167.8 mg/L control sera | 2.1 % @ 13.5 g/L |
| | 1.38% @ 320.7 mg/L control sera | |
| | 5.74% @ 11.7 mg/L human CSF | Inter-Assay CV |
| | | 2.7 % @ 13.2 g/L |
| | Between-run CV | |
| | 1.27% @ 166.6 mg/L control sera | Note: no separate values are<br>given for CSF precision |
| | 2.07% @ 327.7 mg/L control sera | |
| | 6.52% @ 13.21 mg/L human CSF | |
| Analytical Sensitivity | 2 mg/L | Established by lower limit of<br>reference curve; depends on<br>concentration of proteins in N<br>Protein Standard SL |
| Method Comparison | Tina-Quant ® IgG Gen.2 (x) vs.<br>Dade-Behring IgG on BNII (y)<br>54 samples (6.17-65.5 mg/L) | N/A |
| | Slope = 1.042<br>Intercept= 1-3.903<br>r= 0.988 | |