(32 days)
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No
The summary describes a chemical reagent for laboratory testing, with no mention of AI or ML technology.
No.
The device is a reagent used for diagnostic testing, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the results obtained from using the Calcium Reagent are "used in the diagnosis and treatment" of several medical conditions. This indicates its role in identifying or confirming diseases, which is the definition of a diagnostic device.
No
The device description clearly states "Calcium Reagent," which is a chemical substance used in laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of serum calcium." This involves testing a sample taken from the body (serum) outside of the body (in vitro).
- Purpose: The results are used in the "diagnosis and treatment" of various medical conditions. This is a key characteristic of IVDs, which provide information for medical decision-making.
- Device Description: While simple, the description "Calcium Reagent" indicates a substance used in a laboratory test.
The definition of an IVD generally includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures. This device fits that description.
N/A
Intended Use / Indications for Use
Calcium Reagent is intended for the quantitative determination of serum calcium using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of hyperparathyroidism, hypoparathyroidism, multiple myeloma, nephrosis, nephritis, pancreatitis and hypervitaminosis D.
Product codes
CIC
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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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 a stylized image of an eagle with three heads, each head slightly overlapping the previous one, creating a sense of depth and movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 1997
Cynthia Shuqart President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821
K971907 Re : Calcium Reagent Regulatory Class: II Product Code: CIC Dated: May 9, 1997 May 23, 1997 Received:
Dear Ms. Shuqart:
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 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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
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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 w 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 premarket notification" (21 CFR 807.97). 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
Enclosure
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510(k) Number (if known): KG7/907
Calcium Reagent Device Name:
Indications For Use:
Calcium Reagent is intended for the quantitative determination of serum calcium using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of hyperparathyroidism, hypoparathyroidism, multiple myeloma, nephrosis, nephritis, pancreatitis and hypervitaminosis D.
(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 K971907
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)