Measurement of transferrin levels aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Device Description

The Wako Transferrin test is an in vitro diagnostic assay for the quantitative determination of transferrin in serum.

AI/ML Overview

Here's an analysis of the provided text regarding the Wako Transferrin test, focusing on acceptance criteria and supporting study details:

The provided 510(k) summary for the Wako Transferrin test is quite limited in detail regarding specific acceptance criteria and the comprehensive study design. It primarily focuses on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the specific numerical acceptance criteria are not explicitly stated, nor is a detailed breakdown of different performance metrics (e.g., sensitivity, specificity, accuracy against a reference standard). Instead, the performance is described in terms of a correlation to a predicate device and a minimum detection limit.

Acceptance Criteria (Implied/Stated)	Reported Device Performance
Substantial Equivalency to Predicate Device:	Correlation Coefficient: 0.988 with the Beckman Transferrin product.
Linearity/Relationship to Predicate: (Not explicitly stated as an acceptance criterion, but demonstrated)	Regression Equation: y = 0.975x + 0.41 (where y is Wako Transferrin, x is Beckman Transferrin).
Precision: (Acceptable for day-to-day use)	"Precision studies indicate acceptable values can be obtained on a day-to-day basis." (No specific numerical range or CV% provided).
Limit of Detection/Minimum Detectable Level: (Acceptance criterion implied for defining lower detection limit)	Minimum Detectable Level: 4.7 mg/dL.

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

Sample Size for the Test Set: Not explicitly stated. The document mentions "comparison studies against the predicate assay," but does not provide the number of samples or subjects used in these studies.
Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective or prospective comparison study, but details are not provided.

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

Not applicable. This device is an in vitro diagnostic assay for quantitative measurement. The "ground truth" for its performance is typically established by comparison to a reference method, a predicate device, or by evaluating its analytical performance (e.g., linearity, precision, accuracy) against known standards or spiked samples. Clinical expert interpretation of results is not the primary ground truth for the device's technical performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for studies where independent experts interpret results (e.g., imaging studies) and their consensus forms the ground truth. For a quantitative diagnostic assay, the "adjudication" is inherent in the reference method or predicate comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study design is typically relevant for interpretative diagnostic devices (e.g., AI in radiology) where human readers are involved in the diagnostic process. The Wako Transferrin test is a standalone in vitro diagnostic assay.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are essentially "standalone" in this context. The Wako Transferrin test is an automated in vitro diagnostic assay. Its performance is evaluated intrinsically through analytical studies (precision, detection limits) and by comparison to another diagnostic assay (predicate device), without human interpretive intervention being part of the primary performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established through:

Comparison to a Predicate Device: The Beckman Transferrin product served as the reference for comparative studies, establishing substantial equivalence.
Analytical Validation: "Precision studies" and determination of a "minimum detectable level" indicate internal analytical validation against established scientific principles for quantitative assays.

8. The Sample Size for the Training Set

Not applicable. The Wako Transferrin test is a chemical immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance relies on the inherent chemical reactions and optical measurement principles.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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K993162

510(k) Summary of Safety and Effectiveness

The Wako Transferrin test is an in vitro diagnostic assay for the quantitative determination of transferrin in serum.

Summary:

Wako Chemicals USA. Inc.

1600 Bellwood Road, Richmond, VA 23237 U.S.A.

Transferrin is the major iron-carrying protein in blood plasma. It is mainly synthesized in the liver. It is a glycoprotein, which has a molecular weight of 80kDa. The molecule is divided in two domains, each conatining one metal-binding site. Iron is the most important metal bound by transferrin in vivo. Clinical evaluation of transferrin levels is useful for the differential diagnosis of anemia and for monitoring its treatment. Assay methods for measuring transferrin have been developed, such as immunochemical methods, nephelometry, radial immunodiffusion(RID), turbidimetric immunossay. Wako transferrin test utilizes turbidimetric immunoassay .

Principle:

When the sample is mixed with Buffer and Antiserum, transferrin in the sample combines specifically with anti-human transferrin antibodies in the Antiserum to vield an insoluable aggregate that causes increased turbidity. The degree of turbidity call an measured optically and is proportional to the amount of transferrin in the sample.

The safety and effectiveness of the Wako Transferrin assay is demonstrated by its substantial equivalency to the Beckman Transferrin product. Both test systems are used complete transferrin in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.988 and a regression equation of y =0.975x + 0.41 was obtained. Precision studies indicate acceptable values can be obtained on a do to day basis. The minimum detectable level of this method is 4.7 mg/dL.

References

Jong, G, et al .: The Biology of Transferrin. Clin. Chim. Acta, 190:1-46, 1990. 1.

September 17, 1999 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237

Telephone (804) 271-7677 Facsimile (804) 271-7791

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

NOV 1 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Tonya Mallory Senior Manager, Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237

Kc: K993162

Trade Name: Wako Transferrin, Transferrin Calibrator Regulatory Class: II Product Codc: DDG Dated: September 17, 1999 Received: September 22, 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 predically of the indications for the indications for use prior to May 28, 1976, the enactment date of the Medical In mierstate comments, 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) of Class III
affecting your designed many be subject to such additional controls. Existing major regulat 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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 of of Page_

K993162 510(k) Number (if known): _ Transfirin assay A/AKU Device Name: Calibrator Transferrin

Indications For Use:

Measurement of transferrin levels aid
in the diagnosis of malnutrition, acute
inflammation, infection, and red blood
cell disorders, such as iron deficiency
anemia.

(PLRASE 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 K993162
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).