(20 days)
Immunoturbidimetric assay for the quantitative in vitro determination of IgM 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 IgM Gen.2 is an immunoturbidimetric assay. Anti-IgM antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
The Acceptance Criteria for the "Tina-quant IgM Gen.2" device are not explicitly detailed in the provided text in a quantitative manner (e.g., specific thresholds for accuracy, precision, or comparison to a gold standard). However, the document does describe the performance characteristics of the device, particularly its measuring range, and indicates its substantial equivalence to a predicate device.
The study presented focuses on demonstrating substantial equivalence to the predicate device, "Roche Diagnostics Tina-quant IgM assay" (K955908). The key performance aspect discussed is the measuring range.
Here's an attempt to structure the information based on the provided text, recognizing that some of the requested categories are not explicitly covered due to the nature of a 510(k) summary for an in vitro diagnostic device:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the document (510(k) summary for an in vitro diagnostic device), "acceptance criteria" are implied by the performance characteristics presented and the claim of substantial equivalence to a predicate device. The primary performance characteristic highlighted for comparison is the measuring range.
| Acceptance Criterion (Implied) | Reported Device Performance (Tina-quant IgM Gen.2) | Predicate Device Performance (Tina-quant IgM) |
|---|---|---|
| Measuring Range | ||
| Standard Application: | ||
| Roche/Hitachi 902 | 25 - 650 mg/dL | 30 - 490 mg/dL |
| Roche/Hitachi 904/911/912/917/Modular | 25 - 650 mg/dL (3 - 3660 mg/dL with rerun) | 25 - 650 mg/dL (3 - 5362 mg/dL with rerun) |
| Sensitive Application: | ||
| Roche/Hitachi 902 | 4 - 150 mg/dL | N/A (Sensitive application not listed for predicate) |
| Roche/Hitachi 904/911/912/917/Modular | 4 - 150 mg/dL (1 - 450 mg/dL with rerun) | N/A (Sensitive application not listed for predicate) |
| Intended Use | Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on Roche automated clinical chemistry analyzers. | Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers. |
| Method | Immunoturbidimetric assay | Immunoturbidimetric assay |
| Sample Type | Serum, Plasma: Heparin, EDTA | Serum, Plasma: Heparin, EDTA |
| Expected Values | Adults: 40 - 230 mg/dL; Additional ranges for children 0 - 19 years | 40 - 230 mg/dL |
Note: The "acceptance criteria" for an IVD device in a 510(k) would typically involve demonstrating comparable performance (e.g., accuracy, precision, linearity, interference) to a legally marketed predicate device. The document primarily focuses on outlining the device's characteristics and asserting substantial equivalence rather than listing specific numerical acceptance thresholds. The improved/expanded measuring range and additional pediatric expected values for the Gen.2 device are presented as enhancements while maintaining the core functionality.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically found in the full study report, not the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For an in vitro diagnostic test for IgM levels, the "ground truth" would be established through established analytical methods and reference materials, not expert consensus in the way it would be for image interpretation or clinical diagnosis. The document does not mention experts establishing ground truth for a test set.
4. Adjudication method for the test set
Not applicable. The concept of adjudication (e.g., 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, not for a quantitative in vitro diagnostic device like this IgM assay.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. An MRMC comparative effectiveness study is relevant for devices involving human interpretation, often in imaging or diagnostic assistance, usually with AI. This document pertains to an automated, quantitative immunoassay, which does not involve human "readers" in the diagnostic process beyond interpreting the numerical result.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this is essentially a standalone (algorithm/device only) performance assessment. The "Tina-quant IgM Gen.2" is an automated immunoturbidimetric assay. Its performance is measured directly by its analytical capabilities (measuring range, accuracy, precision, etc.), without human "in-the-loop" interpretation of the primary measurement signal. The results are quantitative numerical values.
7. The type of ground truth used
The ground truth for such an in vitro diagnostic device is implicitly established through reference materials, calibrators, and well-characterized samples with known IgM concentrations, traceable to international standards where available. The document does not explicitly state the specific type of ground truth beyond the general analytical methods.
8. The sample size for the training set
The document does not specify the sample size for any training set. For an IVD, "training set" might refer to samples used during reagent development and initial analytical validation, but this information is not provided.
9. How the ground truth for the training set was established
The document does not specify how the ground truth for a training set (if one was formally used in a machine learning sense, which is unlikely for this type of assay) was established. As mentioned in point 7, the ground truth for an IVD is typically based on analytical reference methods and calibrators.
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MAR 1 0 2904
510(k) Summary - Tina-quant IgM Gen.2
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence | |
|---|---|---|
| Submittername, 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 IgM Gen.2 | |
| Common name: Tina-quant IgM Gen.2 | ||
| Classification name: IgM (Mu chain specific) antigen, antiserum, control | ||
| Devicedescription | The Tina-quant IgM Gen.2 is an immunoturbidimetric assay. Anti-IgMantibodies react with antigen in the sample to form an antigen/antibodycomplex which is measured turbidimetrically. | |
| Intended use | Immunoturbidimetric assay for the quantitative in vitro determination of IgMin human serum and plasma on Roche automated clinical chemistryanalyzers. | |
| PredicateDevice | We claim substantial equivalence to the currently marketed RocheDiagnostics Tina-quant IgM assay. (K955908). |
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510(k) Summary - Tina-quant IgM Gen.2, continued
Reagent Summary The following table describes the similarities and differences between the Tina-quant IgM Gen.2 and the predicate device.
| Topic | Tina-quant IgM(K955908) | Tina-quant IgM Gen.2(Modified Device) |
|---|---|---|
| Intended Use | Immunoturbidimetric assay for thequantitative in vitro determination ofIgM in human serum and plasma onautomated clinical chemistryanalyzers. | Same |
| Method | Immunoturbidimetric assay | Same |
| Sample type | SerumPlasma: Heparin, EDTA | Same |
| Measuringrange | Roche/Hitachi 902:30 - 490 mg/dLRoche/Hitachi904/911/912/917/Modular:25 - 650 mg/dL3 - 5362 mg/dL with rerun | Standard Application:Roche/Hitachi 902:25 - 650 mg/dLRoche/Hitachi904/911/912/917/Modular:25 - 650 mg/dL3 - 3660 mg/dL with rerunSensitive Application:Roche/Hitachi 902:4 - 150 mg/dLRoche/Hitachi904/911/912/917/Modular:4 - 150 mg/dL1 - 450 mg/dL with rerun |
| Expectedvalues | 40 - 230 mg/dL | Adults: 40 - 230 mg/dLAdditional ranges for children 0 - 19years |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight.
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: K040431
Trade/Device Name: Roche Diagnostics Tina-quant IgM Gen.2 Regulation Number: 21 CFR § 866.5550 Regulation Name: Immunoglobulins (Light Chain Specific) Immunological Test System Regulatory Class: II Product Code: DAO 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. Arallett
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): 回线 KOYOY 3 |
Device Name: Tina-quant IgM Gen.2
Indications For Use:
Immunoturbidimetric assay for the quantitative in vitro determination of IgM 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) Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _________________ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
elan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_KO40431 20
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).