(134 days)
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No
The document describes a standard in vitro diagnostic test for calcium levels and contains no mention of AI, ML, or related concepts.
No
This device is for in vitro diagnostic use, meaning it is used to test human samples outside the body, and its purpose is for the quantitative determination of Total Calcium, which aids in diagnosis and treatment monitoring but is not itself a therapeutic intervention.
Yes
The text explicitly states, "Calcium measurements are used in the diagnosis and treatment of hypercalcemia... It is also used in the diagnosis and treatment of hypocalcemia..." which clearly indicates a diagnostic purpose.
No
The intended use clearly states "For IN VITRO diagnostic use" and describes a "calcium test system" intended to measure Total Calcium in biological samples (serum, plasma, urine). This strongly implies a physical device or system that interacts with these samples, not purely software. The lack of a device description further supports this, as a software-only device would typically have a description focusing on the software's function and platform.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For IN VITRO diagnostic use."
- Definition of IVD: The "Identification" section describes the device's purpose as measuring total calcium in biological samples (serum, plasma, urine) and explains how these measurements are used in the diagnosis and treatment of various medical conditions. This aligns perfectly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
The other sections being "Not Found" or "Not Applicable" do not negate the fact that the device is explicitly labeled and described as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use.
Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis
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
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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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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 0 2005
Ms. Penny White, RAC Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE Canada CIE 2A6
Re: K051757 Trade/Device Name: Calcium ADVANCE Assay Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: October 27, 2005 Received: October 28, 2005
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 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 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 Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,
Alberto Guts
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K051757
Device Name:_Calcium-ADVANCE Assay
Indications For Use:
For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use.
Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
SASifford
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051757
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