(76 days)
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No
The summary describes a reagent set for in vitro diagnostic testing of electrolytes and carbon dioxide, with no mention of AI or ML technology in its intended use, device description, or other sections.
No.
The Teco ISE Reagent Set is an in vitro diagnostic device used for quantitative measurement of electrolytes in human serum samples to aid in diagnosis and treatment, not to directly treat a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Teco ISE Reagent Set is used in the diagnosis and treatment electrolyte disorders."
No
The device is a reagent set for in vitro diagnostic use, which are chemical substances used in laboratory tests, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Teco ISE Reagent Set is intended for quantitative measurement of Sodium, Potassium; Chloride and Carbon Dioxide in human serum samples..."
- "This reagent set is intended for in vitro diagnostic use only."
These statements clearly indicate that the device is intended for use outside of the body to examine human specimens (serum) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Teco ISE Reagent Set is intended for quantitative measurement of Sodium, Potassium; Chloride and Carbon Dioxide in human serum samples on the Beckman CX System. Teco ISE Reagent Set is used in the diagnosis and treatment electrolyte disorders. ISE Buffer reagent is intended for quantitative measurement of Sodium, Potassium, and Chloride. ISE Reference Reagent is to provide reference points for Sodium, Potassium, and Chloride. The CO2 Acid Reagent is to release Carbon Dioxide from serum samples. The CO2 Buffer Reagent is to provide a reference point for Carbon Dioxide.
This reagent set is intended for in vitro diagnostic use only.
Product codes
JGS, CEM, CGZ, CHL, JIX
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 4 2005
Mr. Jian Vaeches Teco Diagnostics 1268 N. Lakeview Ave Anaheim. CA 92807
Re:
K052724 Trade/Device Name: Teco ISE Reagent Set for CX System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, CHL, JIX, Dated: November 4, 2005 Received: November 17, 2005
Dear Mr. Vaeches:
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
Alberto Gutierrez, Ph.D.
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
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Indications for Use
510(k) Number (if known): Unknown at this time
Device Name: _ Teco ISE Reagent Set for CX System
Indications For Use: Teco ISE Reagent Set is intended for quantitative measurement of Sodium, Potassium; Chloride and Carbon Dioxide in human serum samples on the Beckman CX System. Teco ISE Reagent Set is used in the diagnosis and treatment electrolyte disorders. ISE Buffer reagent is intended for quantitative measurement of Sodium, Potassium, and Chloride. ISE Reference Reagent is to provide reference points for Sodium, Potassium, and Chloride. The CO2 Acid Reagent is to release Carbon Dioxide from serum samples. The CO2 Buffer Reagent is to provide a reference point for Carbon Dioxide.
This reagent set is intended for in vitro diagnostic use only.
Prescription Use V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Hellekson
Division Sign-Off
Office of in Viro Diagnostic Device Evaluation and Safety
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