(21 days)
No
The description focuses on a standard immunoturbidimetric assay and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) assay used to measure IgG levels, which aids in diagnosis rather than directly treating or preventing a disease.
Yes
Explanation: The device is used to measure IgG levels which aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This indicates a diagnostic purpose.
No
The device is an in vitro diagnostic assay, which is a reagent-based test and not a software-only medical device.
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, plasma and cerebrospinal fluid (CSF)". This clearly indicates the test is performed outside of the body using biological samples.
- Device Description: The "Device Description" further reinforces this by describing an "immunoturbidimetric assay for the quantitative in vitro determination of IgG".
- Nature of the Test: The assay measures the concentration of IgG in biological fluids (serum, plasma, CSF) to aid in diagnosis. This is a hallmark of an in vitro diagnostic test.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers. Measurement of IgG 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)
DEW
Device Description
The Tina-Quant IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF.
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
Not Found
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)
Precision:
Within-run CV
0.65% @ 167.8 mg/L control sera
1.38% @ 320.7 mg/L control sera
5.74% @ 11.7 mg/L human CSF
Between-run CV
1.27% @ 166.6 mg/L control sera
2.07% @ 327.7 mg/L control sera
6.52% @ 13.21 mg/L human CSF
Analytical Sensitivity: 2 mg/L
Method Comparison:
Tina-Quant IgG Gen.2 (x) vs. Dade-Behring IgG on BNII (y)
54 samples (6.17-65.5 mg/L)
Slope = 1.042
Intercept= 1-3.903
r= 0.988
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 2 mg/L
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.
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).
0
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Theresa M. Ambrose, PhD 9115 Hague Rd. Indianapolis, IN 46250
2 2005 MAR
Re: K050113
Trade/Device Name: Tina-Quant IgG Gen.2 Regulation Number: 21 CFR 866.55 10 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test Regulatory Class: Class II Product Code: DEW Dated: January 14,2005 Received: January 18,2005
Dear Dr. Ambrose:
This letter corrects our substantially equivalent letter of February 8,2005 regarding the Tina-Quant IgG Gen.2 in which the dates for submission and receipt were incorrectly entered as January 4 and January 6,2005 respectively.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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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: registrationand listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Robert Beckerh.
Robert L. Becker, Jr., M.D., PhP Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Tina-Ouant ® IgG Gen.2
Indications For Use:
Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers.
Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Prescription Use X AND/OR
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Maria Chan
Division Sign-Off
office of in Viro Diagnostic Device Evaluation and Salely Page 1 of ____________________________________________________________________________________________________________________________________________________________________
STORE ...
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510(k) Summary
| 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 Road | |
| Indianapolis, IN 46250 | |
| (317) 521-3723 | |
| Contact Person: Theresa M. Ambrose | |
| Device Name | Proprietary name: Tina-Quant® IgG Gen.2 |
| Common name: Immunoglobulin G (IgG) Test | |
| Classification name: IgG (gamma chain specific) antigen, antiserum, controls | |
| Device Description | The Tina-Quant ® IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF. |
| Intended use | Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers. |
| Note: Serum and plasma cleared under K040434. | |
| Indications for Use | Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. |
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510(k) Summary, Continued
The Tina-Quanta IgG Gen.2 test system is substantially equivalent to other Substantial equivalence devices legally marketed in the United States. We claim equivalence to in Dade Behring N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) IgG assay on the BN I1 cleared under K943997. Both products are intended for use in the quantitative determination of IgG in human CSF.
The following table compares the Tina-Quanta IgG Gen.2 test system with Substantial equivalence the predicate device. comparison
| Feature | Tina-Quant ® IgG Gen.2 | Dade-Behring N Antisera to Human Immunoglobulins IgG on BN II
(predicate) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical analyzers. | In vitro diagnostic reagents for the quantitative determination of immunoglobulims (IgG, IgA, and IgM) in human serum as well as of IgG in human urine and cerebrospinal fluid (CSF) using the BN systems. |
| Indication for Use | Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. | Quantitative determination of the immunoglobulins can provide important information on the humoral immune status. |
| Assay Protocol | Immunoturbidimetric assay | Immunochemical reaction with formation of immune complexes and measurement of scattered light intensity (nephelometric). |
| Traceability / Standardization | CRM 470 | CRM 470 |
| | | |
| Sample Types | Serum, plasma, CSF | Serum, plasma, urine, CSF |
| Reagent Stability | Unopened at 2-8°C: up to the
expiration date | Shelf life at 2-8°C : until
expiration date |
| | Opened and refrigerated on the
analyzer: 90 days | Opened, capped at 2-8°C: 4
weeks |
| | | On-board: 5 days at 8 hours
each or comparable period of
time (maximum 40 hours) |
| Controls | Sensitive application (CSF):
Precinorm PUC (Proteins in
Urine/CSF) / Precipath PUC | For IgG in urine or CSF:
N/T Protein Control LC
(human) |
| | Standard application (serum,
plasma) :Precinorm Protein /
Precipath Protein | |
| Calibrator | Sensitive application (CSF):
C.f.a.s. (Calibrator for automated
systems) PUC | N Proteins Standard SL
(human) |
| | Standard application (serum,
plasma) : C.f.a.s. Proteins | |
| Instrument | Roche/Hitachi family of
analyzers | BN Systems |
| Limitations | Carryover: to avoid carryover a
sample probe wash is
recommended. | Turbidity and particles in the
sample may interfere with
determination Samples
containing particles must be
centrifuged prior to testing. |
| | Icterus: no significant
interference up to an I index of
60 (60 mg/dL conjugated or
unconjugated bilirubin). | |
| | Falsely low results due to antigen
excess may occur above 1400
mg/L | |
| Ferformance Characteristics for CSF application | | |
| Measuring Range | 2 0 - 200 mg/L
2-1000 mg/L with rerun
(upper limits depend on highest
standard concentration) | Depends on concentration of
proteins in N Protein Standard
SL |
| Expected Values for IgG
in CSF | 10-30 mg/L (according to CRM
470 standardization) | Below 34 mg/L (with reference
to CRM 470_) |
2
5
6
7
| Precision | ||
|---|---|---|
| Within-run CV | Intra-Assay CV | |
| 0.65% @ 167.8 mg/L control sera | 2.1 % @ 13.5 g/L | |
| 1.38% @ 320.7 mg/L control sera | ||
| 5.74% @ 11.7 mg/L human CSF | Inter-Assay CV | |
| 2.7 % @ 13.2 g/L | ||
| Between-run CV | ||
| 1.27% @ 166.6 mg/L control sera | Note: no separate values are | |
| given for CSF precision | ||
| 2.07% @ 327.7 mg/L control sera | ||
| 6.52% @ 13.21 mg/L human CSF | ||
| Analytical Sensitivity | 2 mg/L | Established by lower limit of |
| reference curve; depends on | ||
| concentration of proteins in N | ||
| Protein Standard SL | ||
| Method Comparison | Tina-Quant ® IgG Gen.2 (x) vs. | |
| Dade-Behring IgG on BNII (y) | ||
| 54 samples (6.17-65.5 mg/L) | N/A | |
| Slope = 1.042 | ||
| Intercept= 1-3.903 | ||
| r= 0.988 |