(62 days)
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.
The Boehringer Mannheim Tina-quant ® IgE test is based on the principle of immunological agglutination with enhanced of the reaction by latex.
The provided text describes the Boehringer Mannheim Tina-quant® IgE Test, comparing it to a predicate device (Behring N IgE Test) to establish substantial equivalence. However, the document does not contain details about specific acceptance criteria and a study that proves the device meets those criteria in the format requested.
The text focuses on:
- Device Description and Intended Use: For quantitative in vitro determination of IgE in human serum and plasma as an aid in diagnosing allergic diseases.
- Comparison to Predicate Device: Highlighting similarities in intended use, indications, sample type, assay principle, and standardization, while noting differences in measurement approach, instrument, and reagent formulation.
- Regulatory Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance: The document only states "Performance characteristics: The performance of the Boehringer Mannheim Tina-quant ® IgE Test is substantially equivalent to other products device (cont.) in commercial distribution intended for similar use." It does not provide specific performance metrics or acceptance criteria thresholds.
- Sample size used for the test set and the data provenance: No information on test sets or their characteristics is given.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no mention of a diagnostic study with ground truth establishment.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable, as this is an in-vitro diagnostic device and such a study is not described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a lab test, not an AI algorithm.
- The type of ground truth used: Not applicable, no diagnostic study details are provided.
- The sample size for the training set: Not applicable, no training set details are provided.
- How the ground truth for the training set was established: Not applicable.
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NOV 1 2 1998
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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. |
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation9115 Hague RdIndianapolis, IN 46250(317) 845-3723Contact person: Priscilla A. HamillDate prepared: September 8, 1997 |
| 2) Device name | Proprietary name: Boehringer Mannheim Tina-quant ® IgE TestCommon name: IgEClassification 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 |
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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 ®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-quant ® IgE Test | Behring N Latex IgE Test |
|---|---|---|
| Measure-mentapproach | Photometric | Nephelometric |
| Instrumentrequired | Boehringer Mannheim / Hitachiautomated clinical analyzer | Behring Nephelometer |
| ReagentFormula-tion | Liquid; ready to use | Lyophilized; reconstitutionrequired |
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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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
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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
Division Sign-Off) (Division Sign-On)
Division of Clinical Laboratory D 510(k) Number
§ 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).