(61 days)
Wako IgG HA-Direct product
Not Found
No
The device description details a standard in vitro diagnostic assay based on turbidity measurement, with no mention of AI or ML terms or concepts. The performance studies focus on correlation and precision, typical for such assays, and do not suggest the use of AI/ML algorithms.
No
This device is an in vitro diagnostic assay used for quantitative determination of immunoglobulin G in serum, making it a diagnostic tool rather than a therapeutic one.
Yes
The device is an in vitro assay for the quantitative determination of immunoglobulin G in serum, which is a diagnostic measurement.
No
The device description clearly states it is an "in vitro assay" that involves mixing a sample with solutions and measuring turbidity optically, indicating it is a hardware-based laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "quantitative determination of immunoglobulin G in serum." This involves testing a sample taken from the body (serum) outside of the body (in vitro) to provide information about a patient's health status (measuring IgG levels).
- Device Description: The description details an "in vitro assay" that measures a substance in a sample (IgG in serum) using a chemical reaction and optical measurement. This is a hallmark of in vitro diagnostics.
- Mechanism: The mechanism described (combining sample with reagents to cause turbidity measured optically) is a common method used in IVD assays.
The information provided clearly indicates that this device is designed to perform tests on biological samples outside of the body to aid in diagnosis or monitoring, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wako IgG II - HA test is an in vitro assay for the quantitative determination of immunoglobulin G in serum.
Measurer agnosis . Qid body's metabolism and for agents. Associates to vesist infectious
Product codes (comma separated list FDA assigned to the subject device)
DEW
Device Description
Immunoglobulin G (IgG) is the major immunoglobulin, which makes up 70 to 75% of the total immunoglobulins. In electrophoresis, IgG usually migrates in the y- and slow ß- regions; the heterogeneity of the IgG antibody molecules synthesized by different plasma cells causes the region to stain diffusely. IgG antibodies activate complement via the complement cascade, have affinity to receptors on B cells and macrophages, enhance opsonization, and neutralize toxins in tissue spaces. The quantification of immunoglobulins in serum is important for the diagnosis, monitoring and prognosis of chronic liver disease, infectious disease, lymphocytosis, multiple myeloma, primary and secondary immune failure, etc. The conventional test single radial immunodiffusion (SRID), has been widely used. In recent years, there have been many reports on the use of turbidity or light scattering for the measurement of antigen-antibody complexes formed in solution. Advantages over conventional methods include increased sensitivity, better precision, and shortened assay time. The Wako IgGII-HA test is a highly specific reagent based on turbidimetric immunoassay. When a sample is mixed with the Buffer solution and Anti-IgG, IgG in the sample combines specifically with anti-human IgG antibody in the Anti-IgG to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgG in the sample.
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
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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)
Comparison studies against the predicate assay resulted in a correlation coefficient of 0.997 and a regression equation of y = 0.769 x - 60.71. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 62 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum detectable level: 62 mg/dL
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.
Wako IgG HA-Direct product
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.
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).
0
JAN 18 2000
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters appear to be 'KCG3928'. The characters are written in a dark ink on a white background.
Image /page/0/Picture/2 description: The image shows the word "Wako" in a bold, sans-serif font. The word is white and is set against a black background. The background has a grainy texture, which gives the image a vintage or distressed look. The overall composition is simple and emphasizes the brand name.
00 Bellwood Road, Richmond, VA 23237 U.S.A. elephone (804) 271-7677 Telex 293208 WAKO UR(RCA) Facsimile (804) 271-7791
510(k) Summary of Safety and Effectiveness
The Wako IgG II - HA test is an in vitro assay for the quantitative determination of immunoglobulin G in serum.
Summary:
Immunoglobulin G (IgG) is the major immunoglobulin, which makes up 70 to 75% of the total immunoglobulins. In electrophoresis, IgG usually migrates in the y- and slow ßregions; the heterogeneity of the IgG antibody molecules synthesized by different plasma cells causes the region to stain diffusely. IgG antibodies activate complement via the complement cascade, have affinity to receptors on B cells and macrophages, enhance opsonization, and neutralize toxins in tissue spaces.
The quantification of immunoglobulins in serum is important for the diagnosis, monitoring and prognosis of chronic liver disease, infectious disease, lymphocytosis, multiple myeloma, primary and secondary immune failure, etc. The conventional test single radial immunodiffusion (SRID), has been widely used. In recent years, there have been many reports on the use of turbidity or light scattering for the measurement of antigen-antibody complexes formed in solution. Advantages over conventional methods include increased sensitivity, better precision, and shortened assay time. The Wako IgGII-HA test is a highly specific reagent based on turbidimetric immunoassay. . 2
Principle:
When a sample is mixed with the Buffer solution and Anti-IgG, IgG in the sample combines specifically with anti-human IgG antibody in the Anti-IgG to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgG in the sample.
The safety and effectiveness of the Wako IgG II-HA is demonstrated by its substantial equivalency to Wako IgG HA-Direct product. Both test systems are used to measure IgG in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.997 and a regression equation of y = 0.769 x - 60.71 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 62 mg/dL.
1
510(k) Statement (cont.) Page 2 IgG II HA
References:
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Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 20d Ed., Saunders, Philadelphia, 1994.
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Tsubaki, K. et al., Japanese J. Clin. Chem., 14,185-191 (1985).
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DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.
hung Wallun
September 30, 1999 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of a human figure with three wavy lines emanating from it.
JAN 18 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Tonya Mallory Senior Manager Wako Diagnostics 1600 Bellwood Road Richmond, Virginia 23237
K993928 Re:
Trade Name: Wako IgG II-HA, Immunoglobulin Calibrator Set, Immunoglobulin Standard Regulatory Class: II
Product Code: DEW Dated: September 30, 1999 Received: November 18, 1999
Dear Ms. Mallory:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page__________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known): K993928
Device Name: Wako IgG II HA
Indications For Use:
Measurer agnosis . Qid body's metabolism and for agents.
Associates to vesist infectious
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. H943978
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)