(160 days)
No
The summary describes a chemiluminescence immunoassay and does not mention any AI or ML components.
No
This device is an immunoassay intended for in vitro diagnostic use to measure Soluble Transferrin Receptor levels, aiding in the diagnosis of Iron Deficiency Anaemia. It does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the immunoassay is "intended for use... as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease." This indicates its role in aiding in medical diagnosis.
No
The device description clearly states it is a "two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System," indicating it is a physical assay kit and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Soluble Transferrin Receptor in human serum, EDTA and Heparin plasma". This involves testing biological samples in vitro (outside the body).
- Diagnosis: The intended use also states it's used "as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease." This clearly indicates a diagnostic purpose.
- Device Description: The description mentions it's a "two-site chemiluminescence assay," which is a common technique used in IVD tests to measure substances in biological samples.
- Predicate Device: The presence of a predicate device (K970718, R&D Systems, Inc. Quantikine™ IVD™ Human Soluble Transferrin Receptor Immunoassay) with "IVD" in its name further supports that this type of device falls under the IVD category.
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of Soluble Transferrin Receptor in human serum, EDTA and Heparin plasma as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease.
Product codes
JNM
Device Description
The Nichols Advantage® Soluble Transferrin Receptor Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K 992188
DEC - 6 1999
Nichols Institute Diagnostics Nichols Advantage® Soluble Transferrin Receptor 510(k) Notification
11.0 510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: not known
1. Name of Submitter, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675-4703 Phone: 949-240-5260 Fax: 949-240-5313
Contact Person: James A. Rybski, Ph.D. Date Prepared: June 18, 1999
2. Device Name:
| Trade/Proprietary Name: | Nichols Advantage® Chemiluminescence Soluble
Transferin Receptor Immunoassay |
|-------------------------|---------------------------------------------------------------------------------|
| Common/Usual Name: | Soluble Transferrin Receptor Assay |
| Classification Name: | Soluble Transferrin Receptor Immunological Test System |
3. Predicate Device:
We claim substantial equivalence to the R&D Systems, Inc. Quantikine™ IVD™ Human Soluble Transferrin Receptor Immunoassay (K970718, Cleared May 27, 1997).
4. Device Description:
The Nichols Advantage® Soluble Transferrin Receptor Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System.
1
5. Intended Use:
The Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of Soluble Transferrin Receptor in human serum, EDTA and Heparin plasma as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease.
6. Comparison to predicate device:
The Nichols Advantage® Ferritin Assay is substantially equivalent to other products in commercial distribution for similar use. Most notably, it is substantially equivalent to the R&D Systems, Inc. Quantikine™ IVD™ Human Soluble Transferrin Receptor Immunoassay.
The following tables compare the Nichols Advantage Ferritin Assay with the predicate device, R&D Systems, Inc. Quantikine™ IVD™ Human Soluble Transferrin Receptor Immunoassay.
Similarities:
- Intended Use: For the quantitative determination of sTfR in human serum or plasma. .
- . Both assays use specific antibodies to bind sTfR.
- Both assays use human serum for the test sample. .
- Both assays rely upon a sandwich formation by mouse monoclonal antibodies to . specifically detect sTfR.
- The sensitivity of both assays is sufficient to measure sTfR levels found in normal, ● iron deficient and iron overload patients.
2
Differences:
,
| Feature | Nichols Advantage®
Soluble Transferrin
Receptor Assay | Quantikine™ IVD™
Human Soluble
Transferrin Receptor
Immunoassay |
|-------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Size | 60 microliters | 20 microliters |
| Calibration | Two point calibration every two
weeks (maximum) of stored
working calibration curve; or
when controls out of range. | Five point standard curve run
with each assay. |
| Solid Phase | Streptavidin-coated magnetic
particles. Streptavidin-biotin
separation technology. | Mouse monoclonal anti-sTfR
antibodies adsorbed to
microtiter plate wells. Antibody
sandwich-formation separation
technology. |
| Incubation | One Incubation:
Total of 30 minutes at 37°C | Three Incubations:
Total of 2 hr 30 min at room
temperature (18-25°C) |
| Sensitivity | 0.1 nmol/L | Less than 0.5 nmol/L |
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 6 1999
James A. Rybski, Ph.D. Manager, Research and Development Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, California 92675-4703
K992188 Re:
Trade Name: Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay
Regulatory Class: II Product Code: JNM Dated: September 22, 1999 Received: September 27, 1999
Dear Dr. Rybski:
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 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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Page 2
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 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
5
oomon Transmin noophol 510(k) Notification
INDICATIONS FOR USE STATEMENT 4.0
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay
Indications For Use: The Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of Soluble Transferrin Receptor in human serum, EDTA and Heparin plasma as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease.
(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 | K972188 |
| Prescription Use V | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |