(193 days)
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No
The summary describes a clinical chemistry analyzer using ion-selective electrodes for quantitative determination of electrolytes. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections.
No
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of certain ions in serum, which aids in diagnosis, but it does not directly treat or prevent a disease or condition.
Yes
The device is described as an "ISE module of the DataPro™ Plus Clinical Chemistry Analyzer" which is "intended for the quantitative determination of sodium, potassium and chloride in serum." It also states "The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only," directly indicating its diagnostic purpose. The text further explains how the measurements of these ions are associated with various medical conditions, reinforcing its role in diagnosis.
No
The device is described as an "ISE module of the DataPro™ Plus Clinical Chemistry Analyzer" and uses "ion-selective (ISE) electrodes" and "reagents," indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states:
- "The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes." This describes a test performed on a biological sample (serum) outside of the body to obtain diagnostic information.
- "The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only." This directly labels the device and its components as being for in vitro diagnostic use.
These statements clearly indicate that the device is intended to be used for diagnostic purposes on samples taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes.
Sodium: Disorders of the sodium ion (Na ) can be caused by excessive loss, gain or retention of Na or excessive retention of water. Low Na * can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma.
Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 10mmol/L are fatal in most cases.
Chloride: When the chloride ion (CI) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl" concentration is observed in individuals with salt-losing nephritis whereas an increase in Cl can indicate acute renal failure and metabolic acidosis.
The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.
Product codes
CGZ, CEM, JGS
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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§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(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 features a stylized eagle with three stripes forming its body and wing. The eagle faces left and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Fisher Scientific c/o Bola Nicholson Technical and Operations Manager 171 Industry Drive Pittsburgh, PA 15275-1034
SEP - 4 2007
Re: K070531
Trade/Device Name: ISE Module for the DataPro™ Plus Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride Test Regulatory Class: Class II Product Code: CGZ, CEM, JGS Dated: July 03, 2007 Received: July 09, 2007
Dear Bola Nicholson:
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopes, M.S., D.v.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K070531
Device Name: ISE Module for the DataPro™ Plus
Indications for Use: The ISE module of the DataPro™ Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes.
Sodium: Disorders of the sodium ion (Na ) can be caused by excessive loss, gain or retention of Na or excessive retention of water. Low Na * can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma.
Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 10mmol/L are fatal in most cases.
Chloride: When the chloride ion (CI) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl" concentration is observed in individuals with salt-losing nephritis whereas an increase in Cl can indicate acute renal failure and metabolic acidosis.
The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR ..
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carl C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety