(108 days)
Not Found
Not Found
No
The summary describes a device for quantitative determination of electrolytes, which is a standard laboratory analysis technique and does not mention any AI/ML components or related concepts.
No
This device is for the quantitative determination of electrolytes to assist in the diagnosis and treatment of diseases, not for therapy itself.
Yes
The device is used for the quantitative determination of electrolytes to aid in the diagnosis and treatment of various diseases involving electrolyte imbalance.
No
The intended use describes the quantitative determination of electrolytes in human serum, which strongly implies a physical measurement process requiring hardware (e.g., a laboratory analyzer). The summary does not mention any software-only functionality like data analysis or interpretation of results from an external source.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the product is for the "quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum." This involves testing a biological sample (human serum) outside of the body (in vitro).
- Purpose: The purpose of the determination is for the "diagnosis and treatment of diseases causing an electrolyte imbalance." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
The information provided clearly indicates that this device is designed to perform tests on human biological samples to aid in the diagnosis and treatment of medical conditions, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are offen used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Product codes
CGZ, CEM, JGS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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)
Not Found
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines. The symbol is positioned in the center of the circle.
Public Health Service
OCT 7 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. William F. Walters, Jr. V.P.- Technical Operations Pointe Scientific Inc. 5449 Research Drive Canton, MI 48188
K051646 Re:
Trade/Device Name: ISE Diluent, 1N KCL Internal Reference and ISE standards Low and High Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ, CEM, JGS Dated: September 20, 2005 Received: September 22, 2005
Dear Mr. Walters:
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, de noos mar have been 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 r head ou arrivade 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).
1
Page 2 -
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,
Carol C. Benam
Carol C. Benson, M.A. Acting 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): K051646
Device Name: ISE Diluent, 1N KCL, Internal Reference and ISE standards Low and High.
Indications For Use:
This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are offen used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
C.J.C.K.
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
Page 1 of