(51 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring transferrin levels and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for measuring transferrin levels, which aids in diagnosis. It does not provide any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the measurement of transferrin levels "aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders." Additionally, the "Device Description" identifies it as "an in vitro diagnostic assay."
No
The device is described as an "in vitro diagnostic assay," which typically involves reagents and laboratory equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the measurement of transferrin levels "aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia." This clearly indicates a diagnostic purpose.
- Device Description: The description states "The Wako Transferrin test is an in vitro diagnostic assay for the quantitative determination of transferrin in serum." This directly identifies the device as an in vitro diagnostic assay.
- Nature of the Test: The test measures a substance (transferrin) in a biological sample (serum) to provide information about a patient's health status. This is the fundamental nature of an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes
DDG
Device Description
The Wako Transferrin test is an in vitro diagnostic assay for the quantitative determination of transferrin in serum.
Wako transferrin test utilizes turbidimetric immunoassay.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Serum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Correlation coefficient: 0.988; Regression equation: y =0.975x + 0.41; Minimum detectable level: 4.7 mg/dL.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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
1
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)