(53 days)
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No
The summary describes a standard in vitro diagnostic assay for measuring ferritin levels, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an in vitro diagnostic reagent used for quantitative determination and diagnosis, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the device is "an in vitro diagnostic reagent for the quantitative determination of ferritin... and in the diagnosis and management of iron-related disorders."
No
The device is described as an "in vitro diagnostic reagent" and a "calibrator set," which are physical substances used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The K-ASSAY Ferritin assay is an in vitro diagnostic reagent..."
- "The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent..."
- "For in vitro diagnostic use."
These statements clearly indicate that the device is intended for use in testing biological samples outside of the body to diagnose or manage medical conditions.
N/A
Intended Use / Indications for Use
The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by the particle-enhanced immunoturbidimetric assay. These measurements aid in the diagnosis of ferritin related diseases, such as hemochromatosis (iron overload) and iron deficiency anemia.
The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay.
For in vitro diagnostic use.
Product codes
DBF
Device Description
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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)
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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.
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines representing its wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 9 2002
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
Re: K014293 Trade/Device Name: K-ASSAY Ferritin and K-ASSAY Ferritin Calibrator Set
Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: II Product Code: DBF Dated: January 31, 2002 Received: February 11, 2002
Dear Mr. Getty:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 r ou may , ateres, 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 11 your device to such additional controls. Existing major regulations affecting your device can be found in the Code 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 i lease of advised that I Driseanse or our device complies with other requirements of the Act that I Dr has made a sond regulations administered by other Federal agencies. You must or any I oderal batates and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or N Fart 677, accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by overne (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 equivalence of your device to a legally marketed nouncation. The I Dry imaling of succioin 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 II you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in True allestions on the promotion and advertising of your device, (301) 594-4560. Fudinonally, Ior questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionimation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Collecs "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
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
K-ASSAY Ferritin and K-ASSAY Ferritin Calibrator Set Device Name:
Indications For Use:
The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative The K-ASSAY Fernun assay is an in viro diagnosan roag loagness and platex
determination of ferritin (an iron-storing protein) in human serum and in the determination of lemin (an fron-storing provins of ferritin aid in the particle-ennanced immunoturblumethe accey. These and as hemochromatosis (iron overload) and iron deficiency anemia.
The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay.
For in vitro diagnostic use.
in sau
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K614293
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use _
Optional Format 1-2-96) 12/19/2001
Ferritin $10(k) KAMIYA BIOMEDICAL COMPANY