(35 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay for ferritin, which is a chemical analysis method and does not mention any AI or ML components.
No
This device is an in vitro diagnostic assay used for quantitative determination of ferritin to aid in diagnosis, not a therapeutic device.
Yes
The device is an immunoturbidimetric assay for the quantitative determination of ferritin, which "aids in the diagnosis of diseases affecting iron metabolism" such as hemochromatosis and iron deficiency anemia, clearly indicating its role in diagnosis.
No
The device description clearly states it is a "latex particle enhanced immunoturbidimetric assay" and mentions "reagents" and "standard multipoint" for calibration, indicating it is a laboratory assay kit with physical components, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "quantitative determination of ferritin in human serum or EDTA plasma" and "aids in the diagnosis of diseases affecting iron metabolism." This clearly indicates it's used to test samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The description reiterates the intended use, confirming its purpose in analyzing biological samples.
- Performance Studies: The performance studies describe testing the device with "serum samples" and comparing it to a "predicate device," which is a common practice for IVDs seeking regulatory clearance.
- Predicate Device: The mention of a "Predicate Device" with a K number (K935847 AxSYM Ferritin) strongly suggests that this device is being compared to an already cleared IVD, further supporting its classification as an IVD.
The fact that it analyzes human biological samples (serum or plasma) to provide information for diagnosis is the key characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The quantex Ferritin controls VII are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.
The quantex Ferritin standard multipoint is intended for use in establishing the calloration curve for the quantex Ferritin reagents by turbidimetry.
Product codes (comma separated list FDA assigned to the subject device)
DBF, JJX, JIT
Device Description
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.
The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In a method comparison study evaluating 94 serum samples with Ferritin levels ranging from 3.2 to 1000 ng/ml on an ILab 900/1800, the slope was 0.92 and the correlation coefficient (r) was 0.994 for quantex Ferritin versus the predicate device.
Within precision assessed over multiple runs using quantex Ferritin controls VII on an Lab 900/1800 gave a CV of 4.1% (at a mean of 43.2 ng/mL) and 1.6% (at a mean of 402.8 ng/mL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope: 0.92
Correlation Coefficient (r): 0.994
CV: 4.1% (at a mean of 43.2 ng/mL), 1.6% (at a mean of 402.8 ng/mL)
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.
K935847 AxSYM Ferritin
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).
Not Found
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).
0
MAY 1 0 2004
Section 3 quantex Ferritin 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
April 2, 2004
Name of the device:
quantex Ferritin
Classification name(s):
| 866.5340 | Ferritin Immunological Test System |
|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control |
Class II
Identification of predicate device(s):
K935847 AxSYM Ferritin
Description of the device/intended use(s):
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.
The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Quantex Ferritin is substantially equivalent to the commercially available predicate device, AxSYM Ferritin, in performance and intended use.
Summary of Performance Data:
In a method comparison study evaluating 94 serum samples with Ferritin levels ranging from 3.2 to 1000 ng/ml on an ILab 900/1800, the slope was 0.92 and the correlation coefficient (r) was 0.994 for quantex Ferritin versus the predicate device.
Within precision assessed over multiple runs using quantex Ferritin controls VII on an Lab 900/1800 gave a CV of 4.1% (at a mean of 43.2 ng/mL) and 1.6% (at a mean of 402.8 ng/mL).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 0 2004
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421
K040879 Re:
Trade/Device Name: Quantex Ferritin Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF, JJX, JIT Dated: May 03, 2004 Received: May 04, 2004
Dear Ms. Marble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
2
Page 2
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Joseph L. Ardolett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: quantex Ferritin
Indications for Use:
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The quantex Ferritin controls VII are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.
The quantex Ferritin standard multipoint is intended for use in establishing the calloration curve for the quantex Ferritin reagents by turbidimetry.
Prescription Use
(Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Marie Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KO40879 510(k) _______________________________________________________________________________________________________________________________________________________________________
Section 2
quantex Ferritin 510(k)
Page 1 of 1