(42 days)
AxSYM® Ferritin assay.
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No
The summary describes a standard immunoassay for quantitative determination of ferritin and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) assay used to measure ferritin levels, which aids in diagnosis, rather than directly treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia." This indicates its role in disease diagnosis.
No
The device description clearly states it is a Chemiluminescent Microparticle Immunoassay (CMIA) for use on the Abbott ARCHITECT i System, indicating it is a laboratory assay kit and associated hardware, not a software-only device.
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 and plasma" and that the measurements "aid in the diagnosis of diseases affecting iron metabolism." This clearly indicates that the device is used to test samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description details a "Chemiluminescent Microparticle Immunoassay (CMIA)" performed on "human serum and plasma." This further confirms that the device is designed to analyze biological samples outside of the body.
- Performance Studies: The performance studies compare the device to a predicate device (AxSYM® Ferritin assay) which is also an IVD for the same purpose. This comparison is typical for demonstrating the performance of a new IVD.
The core function of the device is to analyze a biological sample (serum or plasma) to provide a quantitative measurement (ferritin levels) that is used to aid in the diagnosis of diseases. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Product codes (comma separated list FDA assigned to the subject device)
DBF
Device Description
The ARCHITECT Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma (lithium heparin or tripotassium EDTA). The ARCHITECT Ferritin assay is calibrated with Abbott ARCHITECT Ferritin Calibrators. Abbott Ferritin Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence has been demonstrated between the ARCHITECT Ferritin assay and the AxSYM® Ferritin assay. The intended use of both assays is for the quantitative determination of ferritin in human serum and plasma. A least squares linear regression analysis between these two assays, using 518 specimens, over the range of 1 to 2000 ng/mL, yielded a correlation coefficient of 0.986, a slope of 1.18, (95% Confidence Interval [CI] of 1.17 to 1.20), and an intercept of -3.65 ng/mL (95% CI of -14.53 to 7.24). Passing-Bablok linear regression analysis between these two assays gave a correlation coefficient of 0.986, a slope of 1.17, (95% CI of 1.16 to 1.19), and an intercept of -1.89 ng/mL (95% CI of -2.64 to -1.23).
In conclusion, these data demonstrate that the ARCHITECT Ferritin assay is as safe and effective as, and is substantially equivalent to, the AxSYM Ferritin assay.
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.
AxSYM® Ferritin assay.
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.
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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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§ 866.5340 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
510(k) Summarv
Abbott ARCHITECT™ Ferritin
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Ferritin constitutes data supporting a substantially equivalent determination.
The ARCHITECT Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma (lithium heparin or tripotassium EDTA). The ARCHITECT Ferritin assay is calibrated with Abbott ARCHITECT Ferritin Calibrators. Abbott Ferritin Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
Substantial equivalence has been demonstrated between the ARCHITECT Ferritin assay and the AxSYM® Ferritin assay. The intended use of both assays is for the quantitative determination of ferritin in human serum and plasma. A least squares linear regression analysis between these two assays, using 518 specimens, over the range of 1 to 2000 ng/mL, yielded a correlation coefficient of 0.986, a slope of 1.18, (95% Confidence Interval [CI] of 1.17 to 1.20), and an intercept of -3.65 ng/mL (95% CI of -14.53 to 7.24). Passing-Bablok linear regression analysis between these two assays gave a correlation coefficient of 0.986, a slope of 1.17, (95% CI of 1.16 to 1.19), and an intercept of -1.89 ng/mL (95% CI of -2.64 to -1.23).
In conclusion, these data demonstrate that the ARCHITECT Ferritin assay is as safe and effective as, and is substantially equivalent to, the AxSYM Ferritin assay.
Prepared and Submitted October 23, 1998 by: Laura Granitz Senior Regulatory Specialist 1-847-938-0092
Abbott Laboratories ADD Regulatory Affairs 200 Abbott Park Road Abbott Park, IL 60064-3537
ARCHITECT Ferritin 510(k) October, 1998 er510k.do
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 7 1998
Laura L. Granitz Sr. Regulatory Specialist Dept. 9V6 Bldg. AP31 ABBOTT LABORATORIES 200 Abbott Park Road Abbott Park, IL 60064-3537
K983759 Re: Trade Name: Abbott ARCHITECT™ Ferritin Regulatory Class: II Product Code: DBF October 23, 1998 Dated: October 26, 1998 Received:
Dear Ms. Granitz:
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 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in four of your device to a legally marketed predicate device equivalence or possification 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 regaration (br on. . please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and 594 4500. Indiations 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 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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510(k) Number (if known): $983751 Device Name: Abbott ARCHITECT™ Ferritin Indications For Use:
The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH/Office of Device Evaluation (QDE),
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983759
Prescription Use √
OR
Over-The-Counter Use _
(Per 21 CFR 801.109)
(Optional Format 1-2-96)