K Number
K983185
Device Name
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
Date Cleared
1998-11-12

(62 days)

Product Code
Regulation Number
866.5510
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The Boehringer Mannheim Tina-quant ® IgE test is based on the principle of immunological agglutination with enhanced of the reaction by latex.
More Information

Behring N IgE test

Not Found

No
The summary describes a standard in vitro diagnostic test based on immunological agglutination, with no mention of AI or ML technologies.

No
This device is an in vitro diagnostic (IVD) test used to determine IgE levels in human samples, aiding in the diagnosis of allergic diseases. It does not provide treatment or therapy.

Yes
The device determines quantitative IgE in human serum and plasma, which is used as an aid in diagnosing allergic diseases. This indicates a diagnostic purpose.

No

The device description explicitly states it is a "test based on the principle of immunological agglutination with enhanced of the reaction by latex," indicating a physical, in vitro diagnostic (IVD) test kit, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states it is for the "quantitative in vitro determination of IgE in human serum and plasma". The term "in vitro" is a key indicator of an IVD.
  • Device Description: The description mentions it's a "test" based on "immunological agglutination", which is a common method used in laboratory tests performed outside the body.
  • Intended User / Care Setting: It's designed for use on "automated clinical chemistry analyzers", which are laboratory instruments.
  • Predicate Device: The mention of a "Predicate Device" (Behring N IgE test) is typical for regulatory submissions for IVDs, demonstrating substantial equivalence to an already approved device.

All these points strongly indicate that this device is intended for use in a laboratory setting to test samples taken from the human body, which is the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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.
IgE determinations are used as an aid in the diagnosis of allergic diseases.

Product codes

DGC

Device Description

The Boehringer Mannheim Tina-quant ® IgE test is based on the principle of immunological agglutination with enhanced of the reaction by latex.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance of the Boehringer Mannheim Tina-quant ® IgE Test is substantially equivalent to other products in commercial distribution intended for similar use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Behring N IgE test

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).

0

NOV 1 2 1998

.

K983185

.

510(k) Summary
IntroductionAccording to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1) Submitter name, address, contactBoehringer Mannheim Corporation
9115 Hague Rd
Indianapolis, IN 46250
(317) 845-3723

Contact person: Priscilla A. Hamill

Date prepared: September 8, 1997 |
| 2) Device name | Proprietary name: Boehringer Mannheim Tina-quant ® IgE Test

Common name: IgE

Classification name: Immunoglobulins A, G, M, D, and E immunological test system |
| 3) Predicate device | We claim substantial equivalence to the Behring N IgE test |
| 4) Device description | The Boehringer Mannheim Tina-quant ® IgE test is based on the principle of immunological agglutination with enhanced of the reaction by latex. |
| 5) 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. |
| | Continued on next page |

1

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 ®
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

2

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.

のお気になる。

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

3

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's authority and purpose.

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

4

Page 2

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

5

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.

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

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

Division Sign-Off) (Division Sign-On)
Division of Clinical Laboratory D 510(k) Number