(20 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative determination of IgG, which aids in diagnosis rather than directly treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This indicates the device provides information used for diagnostic purposes.
No
The device description clearly states it is an "immunoturbidimetric assay," which is a laboratory test method involving reagents and measurement of turbidity, indicating a physical/chemical process, not solely software.
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 IgG in human serum and plasma". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Measurement Aids in Diagnosis: The intended use also states that the measurement "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This indicates the device is used to provide information for diagnostic purposes.
- Sample Type: The assay is performed on "human serum and plasma," which are biological samples taken from the body and analyzed outside of it.
- Device Description: The description details an "immunoturbidimetric assay," which is a laboratory technique used 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 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 IgG 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
DEW
Device Description
The Tina-quant IgG Gen.2 is an immunoturbidimetric assay. Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults: 700 - 1600 mg/dl
Additional ranges for children 0 - 19 years
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
Not Found
§ 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).
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KD40434
MAR 1 0 2004
510(k) Summary - Tina-quant IgG 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 IgG Gen.2 |
| Common name: Tina-quant IgG Gen.2 | |
| Classification name: IgG (Gamma chain specific) antigen, antiserum, control | |
| Device description | The Tina-quant IgG Gen.2 is an immunoturbidimetric assay. Anti-IgG 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 IgG 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 IgG assay. (K955906). |
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510(k) Summary – Tina-quant IgG Gen.2, continued
Reagent Summary
The following table describes the similarities and differences between the Tina-quant IgG Gen.2 and the predicate device.
| Topic | Tina-quant IgG
(K955906) | Tina-quant IgG Gen.2
(Modified Device) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for
the quantitative in vitro
determination of IgG 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:
300 - 3100 mg/dL Roche/Hitachi
904/911/912/917/Modular:
301 - 3500 mg/dL
100 - 19300 mg/dL with rerun | Roche/Hitachi 902:
300 - 3500 mg/dL
Roche/Hitachi
904/911/912/917/Modular:
300 - 5000 mg/dL
40 - 28100 mg/dL with rerun |
| Expected
values | 700 - 1600 mg/dl | Adults: 700 - 1600 mg/dl
Additional ranges for children 0 - 19 years |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract symbol, possibly representing a human figure or a stylized bird.
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: K040434
Trade/Device Name: Roche Diagnostics Tina-quant IgG Gen.2 Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: II Product Code: DEW 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 recuirements, 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. Archellett
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): MA K OYOY34
Device Name: Tina-quant IgG Gen.2
Indications For Use:
Immunoturbidimetric assay for the quantitative in vitro determination of IgG 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 _____________ OR Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Marie Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040434
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