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.

Device Description

The Wako IgM II-HA test is an in vitro assay for the quantitative determination of immunoglobulin M in serum. 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.

AI/ML Overview

The provided 510(k) summary describes the Wako IgM II-HA test, an in vitro assay for the quantitative determination of immunoglobulin M in serum. The safety and effectiveness of this device are demonstrated by its substantial equivalency to a predicate device, the Wako IgM HA-Direct product.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Demonstrated by comparison to the Wako IgM HA-Direct product.
Correlation Coefficient (R)	0.996 (against the predicate assay)
Regression Equation	y = 0.662x - 6.64 (against the predicate assay)
Precision	Acceptable values (obtained on a day-to-day basis)
Minimum Detectable Level	10 mg/dL

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text only mentions "comparison studies against the predicate assay."
- Data Provenance: Not explicitly stated. It is implied to be clinical samples, likely human serum, but details on origin (e.g., country) or whether they were retrospective/prospective are not provided.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable or not stated. This device measures a quantitative analyte and typically relies on established reference methods or predicate devices to define "ground truth" for comparison, rather than expert interpretation.
- Qualifications of Experts: N/A
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or interpretive tasks (e.g., image reading), not for quantitative analytical assays where comparison is made against a reference or predicate method.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was one done? No. MRMC studies are used for interpretive tasks involving human readers, which is not relevant for a quantitative in vitro diagnostic device like the Wako IgM II-HA test.
- Effect size of human readers improvement: Not applicable.
Standalone (Algorithm Only without Human-in-the-Loop Performance) Study:
- Was one done? Yes, effectively. The performance metrics (correlation, regression, precision, minimum detectable level) are reported for the Wako IgM II-HA test itself, independent of human interpretation or intervention beyond the assay's operational steps. The device itself is the "algorithm" in this context.
Type of Ground Truth Used:
- Predicate Device/Reference Method: The "ground truth" for this device's performance evaluation was its substantial equivalency to the Wako IgM HA-Direct product. The predicate device's results served as the reference for comparison, indicating its established accuracy and reliability. While not explicitly stated, "precision studies" would also likely compare against internal quality control materials with known values.
Sample Size for the Training Set:
- Not applicable. This is an immunoassay kit, not a machine learning algorithm that requires a "training set" in the computational sense. The device's performance characteristics are established through analytical verification and validation studies.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this type of device. The accuracy of the Wako IgM HA-Direct product (the predicate device) would have been established through its own rigorous validation studies at the time of its market clearance.

Summary

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JAN 1 4 2000

VO. 2797 P. 11

K993924

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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:

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).
DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.

laTina Mallum
September 30, 1999

LaTonya Mallory Wako Diagnostics 1600 Bellwood Road, Richmond, VA 23237

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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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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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).