← Product Code [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP) · K040435 # ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (K040435) _Roche Diagnostics Corp. · CZP · Mar 10, 2004 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K040435 ## Device Facts - **Applicant:** Roche Diagnostics Corp. - **Product Code:** [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP.md) - **Decision Date:** Mar 10, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.5510 - **Device Class:** Class 2 - **Review Panel:** Immunology - **Attributes:** Pediatric ## Intended Use Immunoturbidimetric assay for the quantitative in vitro determination of IgA 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 IgA Gen.2 is an in vitro diagnostic immunoturbidimetric assay used on Roche automated clinical chemistry analyzers. The device measures IgA levels in human serum or plasma samples. Principle of operation involves anti-IgA antibodies reacting with IgA antigen in the sample to form antigen/antibody complexes, which are then measured turbidimetrically. The output is a quantitative IgA concentration value. The device is intended for use by laboratory professionals in clinical settings. Results assist healthcare providers in diagnosing abnormal protein metabolism and assessing the body's ability to resist infectious agents. ## Clinical Evidence No clinical data provided; substantial equivalence is based on analytical performance comparisons and bench testing of the assay's measuring range and expected values. ## Technological Characteristics Immunoturbidimetric assay; utilizes anti-IgA antibodies for antigen/antibody complex formation; measured via turbidimetry on automated clinical chemistry analyzers; reagent-based; standalone application on Roche/Hitachi systems. ## Regulatory 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 - Roche Diagnostics Tina-quant IgA assay ([K955907](/device/K955907.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K040435 MAR 1 0 2004 # 510(k) Summary - Tina-quant IgA Gen.2 | 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
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831 | | | Contact person: Sherri L. Coenen | | | Date prepared: February 17, 2004 | | Device Name | Proprietary name: Roche Diagnostics Tina-quant IgA Gen.2 | | | Common name: Tina-quant IgA Gen.2 | | | Classification name: IgA antigen, antiserum, control | | Device description | The Tina-quant IgA Gen.2 is an immunoturbidimetric assay. Anti-IgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. | | Intended use | Immunoturbidimetric assay for the quantitative in vitro determination of IgA in human serum and plasma on Roche automated clinical chemistry analyzers. | | Predicate Device | We claim substantial equivalence to the currently marketed Roche Diagnostics Tina-quant IgA assay. (K955907). | {1}------------------------------------------------ ## 510(k) Summary – Tina-quant IgA Gen.2, continued Reagent Summary The following table describes the similarities and differences between the Tina-quant IgA Gen.2 and the predicate device. | Topic | Tina-quant IgA
(K955907) | Tina-quant IgA Gen.2
(Modified Device) | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Immunoturbidimetric assay for the
quantitative in vitro determination of
IgA in human serum and plasma on
automated clinical chemistry
analyzers. | Same | | Method | Immunoturbidimetric assay | Same | | Sample type | Serum
Plasma: Heparin, EDTA | Same | | Measuring
range | Roche/Hitachi 902:
50 - 800 mg/dL
Roche/Hitachi
904/911/912/917/Modular:
50 - 800 mg/dL
5 - 6600 mg/dL with rerun | Standard Application:
Same
Sensitive Application:
Roche/Hitachi 902:
10 - 400 mg/dL
Roche/Hitachi
904/911/912/917/Modular:
10 - 400 mg/dL
4 - 1200 mg/dL with rerun | | Expected
values | 70 - 400 mg/dL | Adults: 70 - 400 mg/dL
Additional ranges for children 0 -- 19
years | {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem of an abstract caduceus-like symbol with three wavy lines, representing health and human services. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The overall design is simple and conveys the department's mission. #### 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: k040435 > Trade/Device Name: Roche Diagnostics Tina-quant IgA Gen.2 Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A,G, M, D, E Immunological Test System Regulatory Class: II Product Code: CZP 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. {3}------------------------------------------------ Page 2 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Joseph L. Arachett 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 {4}------------------------------------------------ ### Indications for Use Statement 510(k) Number (if known): Net Known): Net K O40435 Device Name: Tina-quant IgA Gen.2 Indications For Use: Immunoturbidimetric assay for the quartitative in vitro determination of IgA 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. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use ਮ OR (Per 21 CFR 801.109) (Optional Format 1-2-96) 20 Maria Alan Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K040435 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K040435](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K040435) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com