(57 days)
Not Found
No
The device description details a standard in vitro diagnostic assay based on turbidity measurement, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies focus on correlation and precision, typical for such assays, and there is no information about training or test sets for AI/ML models.
No.
The document explicitly states that the device is an "in vitro assay for the quantitative determination of immunoglobulin M in serum," which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device measures IgM levels in serum, which is an in vitro diagnostic assay used to determine the concentration of a specific analyte, contributing to the diagnosis or monitoring of medical conditions.
No
The device is an in vitro diagnostic assay that measures IgM in serum using chemical reactions and optical turbidity measurement, indicating it is a hardware-based laboratory test, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Measurement of IgM in serum." This is a diagnostic measurement performed on a biological sample (serum) outside of the body.
- Device Description: The description details an "in vitro assay" that measures a substance (immunoglobulin M) in a biological sample (serum) using a chemical reaction that causes turbidity. This is a classic description of an in vitro diagnostic test.
- Input Imaging Modality and Anatomical Site: The "Not Applicable (in vitro diagnostic device)" entries for these fields further confirm its nature as an IVD.
The entire description aligns 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 purposes.
N/A
Intended Use / Indications for Use
The Wako IgM II - HA test is an in vitro assay for the quantitative determination of immunoglobulin M in serum. Measurement of immunoglobulin M in serum for monitoring and prognosis of chronic liver diseases, infectious diseases, lymphocytosis, multiple myeloma, primary and secondary immune failure.
Product codes
CFN
Device Description
Immunoglobulin M (IgM) is the most primitive immunoglobulin and the only immunoglobulin that a neonate synthesizes. In adult serum, it accounts for 5 to 10% of the total circulating immunglobulins. Most of the serum IgM is a pentamer of five IgM monomers. Each monomer has a molecular weight of 185,000. The monomers are attached to each other with the J chain. IgM is an efficient complement activator, has high affinity to bacteria and erythrocytes, and plays a major role in protection from Gram-negative bacterial infection. When a sample is mixed with the Buffer solution and Anti-IgM, IgM in the sample combines specifically with anti-human IgM antibody in the Anti-IgM to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgM in the sample. The minimum detectable level of this method is 10 mg/dL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
The safety and effectiveness of the Wako IgM II-HA is demonstrated by its substantial equivalency to Wako IgM HA-Direct product. Both test systems arc used to measure IgM in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.996 and a regression equation of y = 0.662 x - 6.64 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.996
Predicate Device(s)
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
JAN 1 4 2000
VO. 2797 P. 11
Image /page/0/Picture/3 description: The image contains the word "Wako" in a bold, sans-serif font. The text is white and set against a black background. The letters are slightly condensed, giving the word a compact appearance.
Wako Chemicals USA, Inc.
1600 Bellwood Road, Richmond, VA 23237 U.S.A.
Telephone (804) 271-7677 Telex 293208 WAKO UR(RCA) Facsimile (804) 271-7791
510(K) Summary of Safety and Effectiveness
The Wako IgM II - HA test is an in vitro assay for the quantitative determination of immunoglobulin M in serum,
Summary:
Immunoglobulin M (IgM) is the most primitive immunoglobulin and the only immunoglobulin that a neonate synthesizes. In adult serum, it accounts for 5 to 10% of the total circulating immunglobulins. Most of the serum IgM is a pentamer of five IgM monomers. Each monomer has a molecular weight of 185,000. The monomers are attached to each other with the J chain. IgM is an efficient complement activator, has high affinity to bacteria and erythrocytes, and plays a major role in protection from Gram-negative bacterial infection.
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 include increased sensitivity, better precision, and shortened assay time. The Wako IgM II-HA test is a highly specific reagent based on turbidimetric immunoassay. 112
Principle:
When a sample is mixed with the Buffer solution and Anti-IgM, IgM in the sample combines specifically with anti-human IgM antibody in the Anti-IgM to yield an insoluble aggregate that causes increased turbidity. The degree of turbidity can be measured optically and is proportional to the amount of IgM in the sample.
The safety and effectiveness of the Wako IgM II-HA is demonstrated by its substantial equivalency to Wako IgM HA-Direct product. Both test systems arc used to measure IgM in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.996 and a regression equation of y = 0.662 x - 6.64 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 10 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.
-
Tsubaki, K. et al., Japanese J. Clin. Chem., 14,185-191 (1985).
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DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.
laTina Mallum
September 30, 1999
LaTonya Mallory Wako Diagnostics 1600 Bellwood Road, Richmond, VA 23237
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three wavy lines, which are meant to represent the department's mission of promoting health and well-being.
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: K993924 Trade Name: Wako IgM II HA Immunoglobulin Calibrator Set Regulatory Class: II Product Code: CFN 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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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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of Page_
| 510(k) Number (if known): | K993924 |
|---|---|
| Device Name: | IgM TI HA |
Indications For Use:
Measurement . ભાંવેડ ingu0515 body's metabolism and five to vesist intections ager
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Titus E. Malone
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993924
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)