(160 days)
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.
The Nichols Advantage® Soluble Transferrin Receptor Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System.
The provided text describes the 510(k) notification for the Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay and its comparison to a predicate device. However, it does not include specific acceptance criteria, performance data, or details of a study designed to prove the device meets acceptance criteria. The document focuses on regulatory approval based on substantial equivalence.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text.
Here's what can be extracted based on the information provided:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the text. The document doesn't state specific statistical acceptance criteria for accuracy, precision, or other performance metrics for the Nichols Advantage® assay. It only compares its characteristics (e.g., sensitivity, sample size, incubation) to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. There is no mention of a test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. There is no mention of experts or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
5. 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
This information is not provided in the text. This device is an in-vitro diagnostic immunoassay, not an AI-assisted diagnostic tool for human readers, so an MRMC study in this context would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone immunoassay system. Its performance is determined by the assay itself, not an algorithm that assists a human. The text describes the device's characteristics and its equivalence to a predicate device, which implies standalone performance was evaluated for regulatory purposes. However, specific standalone performance data (e.g., accuracy, precision) against defined acceptance criteria is not provided. The "Sensitivity" listed in the table is a device characteristic, not necessarily a performance outcome against a clinical ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the text. For an immunoassay, the "ground truth" would typically refer to a gold standard method for measuring soluble transferrin receptor or clinical diagnoses against which the assay's results are validated. This is not detailed in the provided summary.
8. The sample size for the training set
This information is not provided in the text. Training sets are typically relevant for machine learning algorithms or for initial assay development/optimization. This document does not describe such studies.
9. How the ground truth for the training set was established
This information is not provided in the text.
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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 SolubleTransferin 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.
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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.
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Differences:
,
| Feature | Nichols Advantage®Soluble TransferrinReceptor Assay | Quantikine™ IVD™Human SolubleTransferrin ReceptorImmunoassay |
|---|---|---|
| Sample Size | 60 microliters | 20 microliters |
| Calibration | Two point calibration every twoweeks (maximum) of storedworking calibration curve; orwhen controls out of range. | Five point standard curve runwith each assay. |
| Solid Phase | Streptavidin-coated magneticparticles. Streptavidin-biotinseparation technology. | Mouse monoclonal anti-sTfRantibodies adsorbed tomicrotiter plate wells. Antibodysandwich-formation separationtechnology. |
| Incubation | One Incubation:Total of 30 minutes at 37°C | Three Incubations:Total of 2 hr 30 min at roomtemperature (18-25°C) |
| Sensitivity | 0.1 nmol/L | Less than 0.5 nmol/L |
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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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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
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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) |
§ 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).