(20 days)
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.
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.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested. The document is a 510(k) summary for the Tina-quant IgA Gen.2, focusing on demonstrating substantial equivalence to a predicate device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance: While there's a table comparing the new device to the predicate in terms of intended use, method, sample type, measuring range, and expected values, these are not acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a direct report of the new device's performance against such criteria.
- Sample size and data provenance for a test set.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or related effect size.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily describes the device, its intended use, and argues for its substantial equivalence to a previously cleared device (Tina-quant IgA, K955907) based on similarities in methodology, intended use, and slight modifications to the measuring range and expected values. It's a regulatory submission for clearance, not a detailed performance study report.
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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 Diagnostics9115 Hague RdIndianapolis 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). |
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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 thequantitative in vitro determination ofIgA in human serum and plasma onautomated clinical chemistryanalyzers. | Same |
| Method | Immunoturbidimetric assay | Same |
| Sample type | SerumPlasma: Heparin, EDTA | Same |
| Measuringrange | Roche/Hitachi 902:50 - 800 mg/dLRoche/Hitachi904/911/912/917/Modular:50 - 800 mg/dL5 - 6600 mg/dL with rerun | Standard Application:SameSensitive Application:Roche/Hitachi 902:10 - 400 mg/dLRoche/Hitachi904/911/912/917/Modular:10 - 400 mg/dL4 - 1200 mg/dL with rerun |
| Expectedvalues | 70 - 400 mg/dL | Adults: 70 - 400 mg/dLAdditional ranges for children 0 -- 19years |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
§ 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).