(17 days)
Not Found
No
The summary describes a standard immunoassay for measuring ferritin levels and makes no mention of AI or ML.
No
This device is an immunoassay for the quantitative determination of ferritin levels, which is a diagnostic tool, not a therapeutic device.
Yes
This device is used for the "quantitative determination of ferritin levels," which is a diagnostic measurement used to assess a patient's health status.
No
The device description explicitly states it comprises reagents, calibrators, and wash buffer used with immunoassay analyzers, indicating it includes physical components and is not solely software.
Yes, based on the provided information, 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 ferritin levels in human serum and plasma (heparin)." This involves testing biological samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details reagents, calibrators, and wash buffer used in conjunction with immunoassay analyzers. These are all components typically used in laboratory settings for in vitro testing.
- Assay Type: It's described as a "paramagnetic particle, chemiluminescent immunoassay," which is a common method for in vitro diagnostic testing.
The core function of the device is to analyze biological samples in vitro to measure a specific analyte (ferritin) for diagnostic purposes, which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Product codes
JMG
Device Description
The Access Ferritin reagents, Access Ferritin Calibrators and the Access The - Access - Land - Saless 2, Synchron LX® 725, and UniCel DxI™ 800) comprise the Access Immunoassay Systems for the quantitative determination of ferritin levels in human serum and plasma (heparin).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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)
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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
Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line.
AUG 1 9 2005
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in This Summary of Creek) in the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7869 Fax: (952) 368-7610 Contact: Carolyn Anderson
Date Prepared: August 1, 2005
Device Names
Ferritin on the Access® Immunoassay Systems Proprietary Name:
Ferritin test system Common Name:
Classification Name: Enzyme Immunoassay, Ferritin
Predicate Device
Access Ferritin Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
510(k) Number: K926221
1
Device Description
The Access Ferritin reagents, Access Ferritin Calibrators and the Access The - Access - Land - Saless 2, Synchron LX® 725, and UniCel DxI™ 800) comprise the Access Immunoassay Systems for the quantitative determination of ferritin levels in human serum and plasma (heparin).
Intended Use
The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
| Attribute | Access Ferritin Assay | Access Ferritin Assay
(modified) |
|--------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Methodology | Two site immunoenzymatic
(sandwich) assay | Two site immunoenzymatic
(sandwich) assay |
| Intended Use | Quantitative determination
of ferritin levels in human
serum and plasma
(heparin) | Quantitative determination
of ferritin levels in human
serum and plasma
(heparin) |
| Solid Phase | Paramagnetic particles
coated with goat anti-
mouse IgG | Paramagnetic particles
coated with goat anti-
mouse IgG |
| Conjugate | Goat anti-ferritin-alkaline
conjugate | Goat anti-ferritin-alkaline
conjugate |
| Calibrators | Human liver ferritin at
levels of 0 and
approximately 10, 50, 200,
500, and 1500 ng/mL
(µg/L) | Human liver ferritin at
levels of 0 and
approximately 10, 50, 200,
500, and 1500 ng/mL
(µg/L) |
Comparison of Technological Characteristics
2
Summary of Technological Characteristics
The device modification consists of the addition of an auto-dilution feature that allows a 1:10 on-board system dilution of human serum and plasma (heparin) anove a The auto-dilution feature is intended for all Access Immunoassay Analyzers (Access, Access 2, SYNCHRON® LXi 725, and UniCel® Dxl 800) and requires a change to the assay-specific software, referred to as the assay protocol file, for each member of this instrument family. The change does not affect assay performance characteristics.
A modification to the assay protocol file (APF) to ensure the main pipettor drops to a sufficient depth in the reagent pack when transferring material from the particle well and the conjugate well is being made to improve particle mixing and to ensure sufficient aspiration of reagents for transfer to the reaction vessel. This modification is being made for both the Ferritin and the auto-dilution (Dil-Ferritin) assays.
The Access Wash Buffer is currently used as the system buffer in the Access Ferritin assay on all Access Immunoassay Analyzers. The labeling is affected in that the directional insert has been revised to describe the addition of the autodilution feature. No changes have been made to the Access, Access 2, SYNCHRON® LXi 725, or UniCel® Dxl 800 system software or hardware. The changes do not affect assay reaction kinetics. No changes have been made to the Access Ferritin assay reagents, calibrators or sample diluent. Access Wash Buffer is used to perform the auto-dilution.
Conclusion
The modified Access Ferritin on the Access Immunoassay Systems including onboard auto-dilutions is substantially equivalent to the Access Ferritin assay for the quantitative determination of ferritin levels in human serum and plasma (heparin).
3
l. continued...
:
:
Indications for Use Statement c.
The indications for use statement appears on the following page.
:
4
Public Health Service
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to promoting health, well-being, and human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)", which is arranged in a circular fashion around the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Beckman Coulter, Inc. c/o Ms Carolyn Anderson Sr. Regulatory Affairs Specialist 1000 Lake Hazeltine Dr. Chaska, MN 55318-1084
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Trade/Device Name: Ferritin on the Access® Immunoassay Systems Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: JMG Dated: August 1, 2005 Received: August 2, 2005
Dear Ms. Anderson:
Re: K052082
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in also 1976, the enactment date of the Medical Device Amendments, or to devices that provision thay 20, 1970, and cordance 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 therefore, maniovate as as as act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
AUG 1 9 2005
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it r your averies to such additional controls. Existing major regulations affecting your device can be fray of babyer of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
5
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 of the Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the Vitto Diagnosto D'ONeo Danding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I vi inay oodin only generational 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/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PK.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known):
Kos2082
Device Name: Access Ferritin on the Access® Immunoassay Systems
Indications For Use:
The Access Ferritin assay is a paramagnetic particle, chemiluminescent The Access - Forman - accept - of its - determination of ferritin levels in human serum immunodouly 16. In the using the Access Immunoassay Systems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_ KO52082