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

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Wako IgG II-HA test:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Predicate Device Comparison	Internal Precision Studies	Minimum Detectable Level
Criteria/Goal	Substantial equivalency demonstrated by strong correlation and regression to predicate.	Acceptable precision studies.	N/A (implied clinical utility requires a certain sensitivity)
Reported Device Performance	Correlation coefficient of 0.997 and regression equation of y = 0.769x - 60.71 with the predicate Wako IgG HA-Direct product.	Precision studies indicate acceptable values can be obtained on a day-to-day basis.	62 mg/dL

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the comparison study or the provenance of the data (country of origin, retrospective/prospective). It only mentions "comparison studies against the predicate assay."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The ground truth for this type of in vitro diagnostic device is typically established by comparing its measurements to a widely accepted reference method or a legally marketed predicate device, rather than involving expert human readers for interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the document describes an in vitro diagnostic assay that generates quantitative results, not a device requiring human interpretation and multi-reader adjudication. The comparison is made between the numerical output of the new device and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human interpretation, not for an in vitro diagnostic assay like the Wako IgG II-HA test, which provides a direct quantitative measurement.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study

Yes, the study described is a standalone performance study. The core of the evidence is the direct comparison of the Wako IgG II-HA test's quantitative results against those of the predicate device (Wako IgG HA-Direct product). There is no "human-in-the-loop" component for interpretation in this context.

7. Type of Ground Truth Used

The ground truth used for establishing the substantial equivalence of the Wako IgG II-HA test is the measurements obtained from a legally marketed predicate device, the Wako IgG HA-Direct product.

8. Sample Size for the Training Set

The document does not specify a training set size. For an in vitro diagnostic device like this, the "training" (or development and optimization) would typically involve internal validation and optimization of the reagent formulation and assay parameters, rather than a distinct "training set" in the machine learning sense. The comparison study acts more like a validation or test set.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the machine learning context is not explicitly described, the method for establishing its ground truth is also not provided. The ground truth for the validation against the predicate device would be the results generated by the predicate device itself.

Summary

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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.

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510(k) Statement (cont.) Page 2 IgG II HA

References:

Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 20d Ed., Saunders, Philadelphia, 1994.
Tsubaki, K. et al., Japanese J. Clin. Chem., 14,185-191 (1985).
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

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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

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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)

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).