(57 days)
HA-Direct
Not Found
No
The description details a turbidimetric immunoassay based on chemical reactions and optical measurement, with no mention of AI or ML terms or concepts.
No
The device is an in vitro diagnostic assay used for quantitative determination of immunoglobulin A in serum, which is for diagnostic purposes, not for treating a disease or condition.
Yes
The device quantitatively determines immunoglobulin A in serum, and such measurements are used to diagnose and monitor various medical conditions.
No
The device description clearly describes a reagent-based in vitro diagnostic assay that measures turbidity, indicating it is a physical kit with chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test is an "in vitro assay for the quantitative determination of immunoglobulin A in serum." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details how the test works by analyzing a sample (serum) outside of the body to measure a specific substance (IgA). This is characteristic of an in vitro test.
N/A
Intended Use / Indications for Use
The Wako IgA II -- HA test is an in vitro assay for the quantitative determination of immunoglobulin A in serum. The quantification of immunoglobulins in serum is important for the diagnosis, monitoring and prognosis of chronic liver diseases, infectious diseases, lymphocytosis, multiple myeloma, primary and secondary immune failure, etc.
Product codes
CZP
Device Description
The Wako IgA II-HA is a highly specific reagent based on turbidimetric immunoassay. When a sample is mixed with the Buffer solution and Anti-IgA, IgA in the sample combines specifically with anti-human IgA antibody in the Anti-IgA to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgA 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
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
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Summary of Performance Studies
Comparison studies against the predicate assay:
- Correlation coefficient: 0.994
- Regression equation: y = 1.227 x - 63.64
Precision studies indicate acceptable values can be obtained on a day to day basis.
Key Metrics
Minimum detectable level of this method is 15 mg/dL.
Predicate Device(s)
To Wako IgA HA-Direct product.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A.
JAN 1 4 2000
Telephone (804) 271-7677 Telex 293208 WAKO UR(RCA) Facsimile (804) 271-7791
510(k) Summary of Safety and Effectiveness
The Wako IgA II -- HA test is an in vitro assay for the quantitative determination of immunoglobulin A in serum.
Summary:
Approximately 10% of Serum immunoglobulin is IgA. In its monometric form, its structure is similar to that of IgG, but 10-15% of IgA in serum is polymetric. Another form of IgA is called secretory IgA. It is found in tears, sweat, saliva, milk, colostrum, and gastrointestinal and bronchial secretions.
The quantification of immunoglobulins in serum is important for the diagnosis, monitoring and prognosis of chronic liver diseases, infectious diseases, 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 increased sensitivity, better precision, and shortened assay time. The Wako IgA II-HA test is a highly specific reagent based on turbidimetric immunoassay. 1,2
Principle:
When a sample is mixed with the Buffer solution and Anti-IgA, IgA in the sample combines specifically with anti-human IgA antibody in the Anti-IgA to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgA in the sample.
The safety and effectiveness of the Wako IgA II-HA is demonstrated by its substantial equivalency to Wako IgA HA-Direct product. Both test systems are used to measure IgA in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.994 and a regression equation of y = 1.227 x - 63.64 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 15 mg/dL.
References:
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Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 2nd 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.
Amra Wallus
September 30, 1999 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines suggesting movement or connection.
JAN 1 4 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Tonya Mallory Senior Manager Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237
Re: K993927 Trade Name: Wako IgA II HA Immunoglobulin Calibrator Set Regulatory Class: II Product Code: CZP 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
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Pag
| Labels | Values |
|---|---|
| 510(k) Number (if known): | 5993927 |
| Device Name: | Wako IgA II HA |
Indications For Use:
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation ODIE
Stur E. Mafini
(Division Sign-Off)
Division of Clinical Laboratory Devices K993927
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)