(27 days)
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No
The summary describes a standard in vitro diagnostic reagent kit based on a chemical reaction and spectrophotometric detection, with no mention of AI or ML.
No
The device is an in vitro diagnostic reagent used to measure iron levels, which helps in diagnosing conditions but does not directly treat or prevent a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic reagent for the quantitative determination of iron in human serum." It further notes its use "to distinguish between different types of anaemias and to identify conditions involving iron deficiency," which describes a diagnostic purpose.
No
The device is an in vitro diagnostic reagent kit, which is a chemical product used for testing, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Randox Laboratories Limited Iron Test Kit is an in vitro diagnostic reagent for the quantitative determination of iron in human serum."
This statement clearly identifies the device as an in vitro diagnostic reagent, which is a type of IVD. The description of its use in testing human serum to aid in the diagnosis of conditions like anemia further confirms its IVD status.
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Iron Test Kit is an in vitro diagnostic reagent for the quantitative determination of iron in human serum. The method is based on the reaction of ferrous iron with the chromogen ferrozine to produce a coloured chromophore which can be detected at 570nm. Serum iron may be used to distinguish between different types of anaemias and to identify conditions involving iron deficiency.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
JMO
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
suitably qualified laboratory personnel under appropriate laboratory conditions.
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
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§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The image is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 6 1998
Dr. P. Armstrong Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, Co. BT29 4QY Antrim, United Kingdom
K974604 Re : Randox Iron II Requlatory Class: Product Code: JMO Dated: December 8, 1997 December 10, 1997 Received:
Dear Dr. Armstrong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marrice 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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, 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 In addition, FDA may publish further announcements action. 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (Chiration. 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 described in your cial equivalence of your device to a legally marketed predicate device results in a classification for your markets production 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 che regulation entitled, "Misbranding by reference to 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/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation .... Center for Devices and Radiological Health
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Enclosure
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| CALLER AND CONSULTER COLLEGE OF CHARRET OF | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------- |
です。
ア
| 0(k) Number (if known) | NOT KNOWN |
|---|---|
| vice Name | IRON |
dications For Use :
ne Randox Laboratories Limited Iron Test Kit is an in vitro diagnostic reagent for the
Jantitative determination of iron in human serum. The method is based on the reaction of
rrous iron with the chromogen ferrozine to produce a coloured chromophore which can
e detected at 570nm. Serum iron may be used to distinguish between different types of
aemias and to identify conditions involving iron deficiency.
his test kit must be used by suitably qualified laboratory personnel under appropriate
boratory conditions.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| 'Yescription Use
Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional format 1-2-96) |
| ----------------------------------------- | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off)
Division of Clinical
| 510(k) Number | 12974604 |
|---|---|
| --------------- | ---------- |