BOEHRINGER MANNHEIM TINA-QUANT IGE TEST

K983185 · Boehringer Mannheim Corp. · DGC · Nov 12, 1998 · Immunology

Device Facts

• Record ID: K983185
• Device Name: BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
• Applicant: Boehringer Mannheim Corp.
• Product Code: DGC · Immunology
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The Boehringer Mannheim Tina-quant ® IgE test is intended for the quantitative in vitro determination of IgE in serum and plasma on automated clinical chemistry analyzers.

Device Story

The Boehringer Mannheim Tina-quant IgE Test is an in vitro diagnostic reagent kit used for the quantitative measurement of IgE in human serum and plasma. The device utilizes a particle-enhanced immunological agglutination principle, where latex particles are used to enhance the reaction. The assay is designed for use on automated clinical chemistry analyzers (specifically Boehringer Mannheim/Hitachi systems). The test is performed in a clinical laboratory setting by trained personnel. The output is a quantitative IgE concentration value, which clinicians use as an aid in the diagnosis of allergic diseases. The reagent is provided in a liquid, ready-to-use format, offering a workflow advantage over lyophilized alternatives.

Clinical Evidence

Bench testing only. Performance characteristics were evaluated and compared to the predicate device. The assay is standardized against the WHO Standard.

Technological Characteristics

Particle-enhanced immunological agglutination assay. Reagent is liquid and ready-to-use. Designed for photometric measurement on automated clinical chemistry analyzers (Boehringer Mannheim/Hitachi). Standardized against WHO Standard.

Indications for Use

Indicated for the quantitative in vitro determination of IgE in human serum and plasma as an aid in the diagnosis of allergic diseases.

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

• Behring N IgE test

Submission Summary (Full Text)

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# NOV 1 2 1998

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K983185

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| <b>510(k) Summary</b> | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Introduction</b> | 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. |
| <b>1) Submitter name, address, contact</b> | Boehringer Mannheim Corporation<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>[phone]<br><br>Contact person: Priscilla A. Hamill<br><br>Date prepared: September 8, 1997 |
| <b>2) Device name</b> | Proprietary name: Boehringer Mannheim Tina-quant ^® IgE Test<br><br>Common name: IgE<br><br>Classification name: Immunoglobulins A, G, M, D, and E immunological test system |
| <b>3) Predicate device</b> | We claim substantial equivalence to the Behring N IgE test |
| <b>4) Device description</b> | The Boehringer Mannheim Tina-quant ^® IgE test is based on the principle of immunological agglutination with enhanced of the reaction by latex. |
| <b>5) Intended use</b> | The Boehringer Mannheim Tina-quant ^® IgE test is intended for the quantitative in vitro determination of IgE in serum and plasma on automated clinical chemistry analyzers. |
| | <i>Continued on next page</i> |

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## 510(k) Summary, Continued

The Boehringer Mannheim Tina-quant ® IgE Test is substantially equivalent 6) Comparison to other products in commercial distribution intended for similar use. Most to the predicate device notably, it is substantially equivalent to the currently marketed Behring N IgE test.

#### Similarities:

#### The following table compares Boehringer Mannheim ® IgE Test with the Similarities predicate device. Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5. Labeling for the predicate device is provided in Attachment 6.

#### Similarities

| Feature | Boehringer Mannheim Tina-quant ®<br>IgE Test | Behring N IgE Test |
|--------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Intended use | For the quantitative determination of IgE in human serum and plasma on automated clinical chemistry analyzers | For the quantitative determination of IgE in human serum and plasma on automated clinical chemistry analyzers |
| Indications for use | An aid in the diagnosis of allergic diseases | An aid in the diagnosis of allergic diseases |
| Sample type | Human serum, plasma | Human serum, plasma |
| Assay reaction principle | Particle-enhanced immunological agglutination | Particle-enhanced immunological agglutination |
| Standard-ized against | WHO Standard | WHO Standard |

Continued on next page

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### 510(k) Summary, Continued

#### Differences

Differences: The following differences between Boehringer Mannheim Tina-quant ® IgE Test and the predicate device are not significant for purposes of determining substantial equivalence.

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| Feature | Boehringer Mannheim Tina-<br>quant ® IgE Test | Behring N Latex IgE Test |
|------------------------------|--------------------------------------------------------------|-----------------------------------------|
| Measure-<br>ment<br>approach | Photometric | Nephelometric |
| Instrument<br>required | Boehringer Mannheim / Hitachi<br>automated clinical analyzer | Behring Nephelometer |
| Reagent<br>Formula-<br>tion | Liquid; ready to use | Lyophilized; reconstitution<br>required |

Performance characteristics: The performance of the Boehringer 6) Comparison to predicate Mannheim Tina-quant ® IgE Test is substantially equivalent to other products device (cont.) in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring N IgE test.

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### NOV 1 2 1998

Ms. Priscilla A. Hamill Regulatory Affairs Consultant Roche Diagnostics/Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250

K983185 Re:

> Boehringer Mannheim Tina-quant® IgE Test Trade Name: Requlatory Class: II Product Code: DGC Dated: September 8, 1998 September 11, 1998 Received:

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturinq Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ _ K 983185

Device Name: Boehringer Mannheim Tina-quant ® IgE Test

Indications for Use: For the quantitative in vitro determination of IgE in human serum and plasma on automated clinical chemistry analyzers. IgE determinations are used as an aid in the diagnosis of allergic diseases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

@ptional format 1-2-96)

Peter E. Maler

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