The Wako IgA II-HA test 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.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the device study:

Device: Wako IgA II-HA test (for quantitative determination of immunoglobulin A in serum)

Acceptance Criteria and Device Performance

The provided documentation does not explicitly state pre-defined "acceptance criteria" in the format of a threshold that the device needed to meet. Instead, the safety and effectiveness are established through substantial equivalency to a predicate device (Wako IgA HA-Direct product). The performance metrics reported are primarily comparative.

Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not presented, the table below reflects how the device performance was compared to its predicate to establish substantial equivalence.

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Wako IgA II-HA vs. Wako IgA HA-Direct)
Correlation Coefficient	High correlation to predicate device	0.994
Regression Equation	Relationship to predicate device indicating similar measurement	y = 1.227x - 63.64
Precision	Acceptable values on a day-to-day basis	"Precision studies indicate acceptable values can be obtained on a day to day basis." (Specific metrics not provided)
Minimum Detectable Level	Not explicitly stated as a comparative criterion, but a performance characteristic.	15 mg/dL
Intended Use	Identical to predicate device	Used to measure IgA in serum

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify the sample size for the comparison study.
- The country of origin for the data is not specified.
- The study type (retrospective or prospective) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The comparison is against a predicate device, which implies the predicate's measurements serve as a reference, but it doesn't detail how the "ground truth" for the predicate itself was established in this context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This type of adjudication method is not applicable as the study described is a comparison of two quantitative analytical devices, not an interpretive task often subject to expert adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not conducted. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluated is that of the device algorithm (turbidimetric immunoassay) in a standalone manner, as it quantitatively determines IgA in serum. Human intervention is involved in operating the device and collecting samples, but the core measurement and comparison are algorithm-driven.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is implicitly the measurements obtained from the predicate device, Wako IgA HA-Direct product. The study demonstrates the correlation and regression of the new device's measurements against those of the legally marketed predicate. This is a common approach for establishing substantial equivalence for IVDs.
The sample size for the training set:
- The concept of a "training set" is not applicable here as this is a traditional in-vitro diagnostic assay validation, not a machine learning model.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of a machine learning model.

Summary

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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:

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.

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:

. Qill GUOSIS metaboli'sm 000m 5 film to vesist agen Intectious

(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)

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).