(20 days)
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No
The description details a standard immunoturbidimetric assay, which is a chemical reaction measured by turbidity. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic assay used for quantitative determination of IgM, aiding in the diagnosis of abnormal protein metabolism, rather than directly treating or preventing disease.
Yes
The device is used for the quantitative in vitro determination of IgM in human serum and plasma, and its measurement "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This directly indicates its use in diagnostics.
No
The device is an immunoturbidimetric assay, which is a laboratory test involving reagents and a clinical chemistry analyzer, indicating it is a hardware-based diagnostic device, not software-only.
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 an "in vitro determination of IgM in human serum and plasma". "In vitro" means "in glass" or "in a test tube," referring to tests performed outside of the living body.
- Sample Type: The assay uses human serum and plasma, which are biological samples taken from a patient.
- Purpose: The measurement "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This indicates the test is used for diagnostic purposes.
- Device Description: The description details an "immunoturbidimetric assay," which is a common method used in laboratory diagnostics to measure substances in biological fluids.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DAO
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adults: 40 - 230 mg/dL Additional ranges for children 0 - 19 years
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
MAR 1 0 2904
510(k) Summary - Tina-quant IgM 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 IgM Gen.2 | |
| | Common name: Tina-quant IgM Gen.2 | |
| | Classification name: IgM (Mu chain specific) antigen, antiserum, control | |
| Device
description | 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. | |
| Intended use | Immunoturbidimetric assay for the quantitative in vitro determination of IgM
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 IgM assay. (K955908). | |
1
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 the
quantitative in vitro determination of
IgM 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:
30 - 490 mg/dL
Roche/Hitachi
904/911/912/917/Modular:
25 - 650 mg/dL
3 - 5362 mg/dL with rerun | Standard Application:
Roche/Hitachi 902:
25 - 650 mg/dL
Roche/Hitachi
904/911/912/917/Modular:
25 - 650 mg/dL
3 - 3660 mg/dL with rerun
Sensitive Application:
Roche/Hitachi 902:
4 - 150 mg/dL
Roche/Hitachi
904/911/912/917/Modular:
4 - 150 mg/dL
1 - 450 mg/dL with rerun |
| Expected
values | 40 - 230 mg/dL | Adults: 40 - 230 mg/dL
Additional ranges for children 0 - 19
years |
2
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