(54 days)
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No
The description details a chemical reaction and spectrophotometric measurement, with no mention of AI or ML.
No
The device is an in vitro diagnostic reagent used for the quantitative determination of calcium in human serum, which aids in diagnosis and treatment monitoring, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of calcium are used in the diagnosis and treatment of parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure and a variety of bone diseases." This indicates its role in disease diagnosis.
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, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says "The Randox Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum." It also describes its use in the diagnosis and treatment of various medical conditions.
- Device Description: The description reinforces that it is an "in vitro diagnostic reagent" and explains how it works to measure a substance in a biological sample (human serum).
The core definition of an IVD is a medical device used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum. This method is based on the interaction of calcium with Arsenazo III to form a coloured complex which can be measured at 650nm. The intensity of the final colour is directly proportional to the calcium concentration. Measurements of calcium are used in the diagnosis and treatment of parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure and a variety of bone diseases.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Product codes
CJY
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.
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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures, possibly representing people or families, with their arms raised.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 2 1000
Dr. P. Armstrong Requlatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, Co., Antrim, United Kingdom, BT29 4QY
Re : K974607 Randox Calcium Requlatory Class: II Product Code: CJY Dated: December 5, 1997 Received: December 10, 1997
Dear Dr. Armstrong:
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 reqistration, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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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Page 2
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 - -------------------------------------------------------------------------------------------------------------------Other general premarket notification" (21 CFR 807.97). 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 Litman
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)_ NOT KNQWN
Device Name ___CALCIUM - ARSENAZO III
Indications For Use :
The Randox Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum. This method is based on the interaction of calcium with Arsenazo III to form a coloured complex which can be measured at 650nm. The intensity of the final colour is directly proportional to the calcium concentration. Measurements of calcium are used in the diagnosis and treatment of parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure and a variety of bone diseases.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974607
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional format 1-2-96)