(66 days)
IMX® Ferritin
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No
The summary describes a standard immunoassay kit and analyzer for measuring ferritin levels, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device measures ferritin levels to aid in diagnosis, it does not treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that OPUS Ferritin is "an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia," which clearly indicates its use in diagnosing medical conditions.
No
The device description explicitly states it is a "set of reagents" intended for use with "OPUS immunoassay analyzers," indicating it is a hardware/reagent-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that OPUS Ferritin is an "in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum". The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device measures ferritin in "human serum," which is a biological sample taken from the body and analyzed outside the body.
- Purpose: The purpose is to aid in the diagnosis of medical conditions ("hemochromatosis (iron overload) and iron deficiency anemia"). This diagnostic purpose is a core function of IVDs.
- Device Description: The "Device Description" further clarifies that it's a "set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum." Reagents used to analyze biological samples outside the body are components of IVDs.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.
Product codes
DBF
Device Description
OPUS Ferritin is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum.
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
Precision
Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 5.5% to 7.00%.
Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 4.60% to 9.00%.
Accuracy by Recovery
Recovery was determined by spiking previously assaved and pooled human serum matrix with different levels of ferritin. The samples were assaved using OPUS Ferritin in triplicate. Percent recovery ranged from 89 to 101%.
Accuracy by Correlation
OPUS Ferritin was compared to a commercially available Ferritin assay by evaluation of 70 serum samples ranging from 2.31 to 807.00 ng/ml. A correlation coefficient of 0.98 was obtained, with a v-intercept value of 11.95 and a slope of 0.92.
Key Metrics
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Predicate Device(s)
IMX® Ferritin
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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K973202
Sept. 12, 1997
Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification
510(k) Summary for OPUS Ferritin
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
Manufacturer:
Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn: Ruth Forstadt
Preparation date:
July 7, 1997
2 . Classification: Device Name/
Ferritin Test System OPUS Ferritin: Classification Number: Class II (866.5340).
3 . ldentification of the legally marketed device:
IMX® Ferritin
4 . Proposed Device Description:
OPUS Ferritin is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum.
5 . Proposed Device Intended Use:
OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.
ه والا والا والا والان والان والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتهار والتها و ...
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Image /page/0/Picture/17 description: The image displays the word "CONFIDENTIAL" in large, bold, black letters. The text is slightly angled, giving it a dynamic appearance. The font is sans-serif, and the letters are closely spaced, creating a strong visual impact.
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Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification
Medical device to which equivalence is claimed and comparison 6. information:
The OPUS Serum Ferritin assay is substantially equivalent in intended use to results obtained using the Abbott IMX Ferritin. The Abbot IMX Ferritin, like the proposed product, employs the principle of two site or sandwich immunoassay. Both methods use a labeled antibody for the quantitative measurement of ferritin in human serum. The OPUS Serum Ferritin and Abbott IMX Ferritin are both based on a six level calibrator system. Also, both the Abbott IMX Ferritin and the OPUS Serum Ferritin assay include a tri-level control.
The OPUS Serum Ferritin differs from the Abbott IMX Ferritin in that human serum and plasma samples may be used in the Abbott IMX Ferritin and only human serum in the OPUS Serum Ferritin assay.
7. Device Performance Characteristics:
Precision
Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 5.5% to 7.00%.
Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 4.60% to 9.00%.
Accuracy by Recovery
Recovery was determined by spiking previously assaved and pooled human serum matrix with different levels of ferritin. The samples were assaved using OPUS Ferritin in triplicate. Percent recovery ranged from 89 to 101%.
Accuracy by Correlation
OPUS Ferritin was compared to a commercially available Ferritin assay by evaluation of 70 serum samples ranging from 2.31 to 807.00 ng/ml. A correlation coefficient of 0.98 was obtained, with a v-intercept value of 11.95 and a slope of 0.92.
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CONFIDENTIAL
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design, resembling an eagle or bird in flight, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the top portion of the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 2 1997
Ms. Ruth Forstadt Regulatory Affairs Associate Behring Diagnostics Inc. 151 University Avenue Westwood, Massachusetts 02090
Re : K973202 OPUS® Serum Ferritin Trade Name: Product Code: Regulatory Class: II DBF JMJ II Dated: July 7, 1997 Received: July 8, 1997
Dear Ms. Forstadt:
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 current Good Manufacturing Practice requirement, 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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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 Autman
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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Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification
Page of
510(k) Number (if known): K973302
Device Name:
MASTER THE WE WE & AND THE BEARTH
un wur uu
OPUS Ferritin Test System
Indications For Use:
OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suta E. Madina
(Division Sign-Off)
AVICT :: ''; Clinical Laber a!u:
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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CONFIDENTIAL