(90 days)
Not Found
No
The summary describes a standard enzyme immunoassay (ELISA) kit for measuring a specific protein. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on traditional assay characteristics.
No
Explanation: This device is an in vitro diagnostic (IVD) assay intended for the measurement of sTfR concentration to aid in the diagnosis of iron deficiency anemia. It does not directly treat or alleviate a disease, but rather provides diagnostic information.
Yes
The "Intended Use / Indications for Use" states that the assay is "as an aid in the diagnosis of iron deficiency anemia".
No
The device description clearly states it is a "microtiter-plate-based sandwich enzyme immunoassay," which is a laboratory test involving physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease." This clearly indicates that the device is used to examine specimens derived from the human body (serum or plasma) to provide information for diagnostic purposes.
- Device Description: The description of the device as a "microtiter-plate-based sandwich enzyme immunoassay for soluble transferrin receptor" further confirms that it is a laboratory test performed on biological samples.
These points align directly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a transplant, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
Product codes (comma separated list FDA assigned to the subject device)
JNM
Device Description
The product is a microtiter-plate-based sandwich enzyme immunoassay for soluble transferrin receptor.
R&D Systems' Quantikine IVD sTfR ELISA kit has an intended use that is similar to the predicate device. The technologies of the two devices are similar in that both are immunoassays involving the solid phase binding of an antibody-analyte-antibody* complex. They differ in the "reporter" moiety (*) attached to the complex. R&D System's assay is based on a colorimetric reaction and Sanofi's is chemiluminescent.
Testing of performance characteristics centered on the attributes of precision, linearity, specificity, sensitivity and stability. The assay is run at room temperature on the bench top.
Expiration dating for the kit has been established at 13 weeks when stored at 2-8℃ and handled according to instructions for use. Opened or diluted reagents are good for up to 4 weeks when stored at 2-8℃ provided that this is within the expiration date. The controls provided with the kit are lyophilized; once they are reconstituted they are stable for a minimum of 4 weeks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of performance characteristics centered on the attributes of precision, linearity, specificity, sensitivity and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
MAY 27 1997
510(k) Summary Quantikine™ IVD™ sTfR ELISA kit
Date of Summary: Company Name:
Contact name:
February 14, 1997 R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Kenneth T. Edds, Ph.D. 612-379-2956, FAX 612-379-6580
Classification name: Product name: Device Class:
sTfR immunological test system Quantikine IVD sTfR immunoassay Class II
Device to which substantial equivalence is claimed: Sanofi Diagnostics ferritin assay, Chaska, MN, K926221
The product is a microtiter-plate-based sandwich enzyme immunoassay for soluble transferrin receptor.
The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
R&D Systems' Quantikine IVD sTfR ELISA kit has an intended use that is similar to the predicate device. The technologies of the two devices are similar in that both are immunoassays involving the solid phase binding of an antibody-analyte-antibody* complex. They differ in the "reporter" moiety (*) attached to the complex. R&D System's assay is based on a colorimetric reaction and Sanofi's is chemiluminescent.
Testing of performance characteristics centered on the attributes of precision, linearity, specificity, sensitivity and stability. The assay is run at room temperature on the bench top.
Expiration dating for the kit has been established at 13 weeks when stored at 2-8℃ and handled according to instructions for use. Opened or diluted reagents are good for up to 4 weeks when stored at 2-8℃ provided that this is within the expiration date. The controls provided with the kit are lyophilized; once they are reconstituted they are stable for a minimum of 4 weeks.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 27 1997
Kenneth T. Edds, Ph.D. Regulatory Affairs R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413
K970718 Re: Trade Name: Quantikine IVD sTfR Immunoassay Regulatory Class: II Product Code: JNM Dated: February 26, 1997 Received: February 26, 1997
Dear Dr. Edds:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 is 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.
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.
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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 Sutman
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
3
510(k) Number:
Device Name: The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay
Indications for Use: The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
Gita E. Makeri
(Division Jun. 097 Laboratory D ""ines Divi : Dit . . . . .
510(k) Number __ and, and I am sorry for the inconvenience.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-CounterUse
(Optional Format 1-2-96)
$k=3^{k}