(76 days)
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.
Not Found
This document is a 510(k) premarket notification letter from the FDA for a device called "Teco ISE Reagent Set for CX System." It primarily addresses the regulatory approval of the device and its intended use, rather than a detailed study report with acceptance criteria and performance data.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text. This document is a regulatory approval, not a scientific study report.
However, based on the limited information, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device performance was compared to existing, approved devices, but the specific acceptance criteria and the detailed performance metrics of the Teco ISE Reagent Set are not disclosed in this letter.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided in the document. The device is a "Teco ISE Reagent Set" for quantitative measurement of analytes, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided in the document. This device is a reagent set, not an algorithm. However, the performance assessment would effectively be "standalone" in the sense that the reagent set's analytical performance on the Beckman CX System would be evaluated independently. The document does not detail this evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a diagnostic reagent set, the "ground truth" would typically be established through reference methods (e.g., highly accurate laboratory techniques, certified reference materials) or comparison to predicate devices with established accuracy. However, this specific information is not provided in the document.
8. The sample size for the training set:
This information is not applicable and not provided in the document. Reagent sets, unlike machine learning algorithms, do not typically have "training sets." Their performance is validated through analytical studies.
9. How the ground truth for the training set was established:
This information is not applicable and not provided in the document.
Summary of available information:
The provided document is a regulatory approval letter. It confirms the "Teco ISE Reagent Set for CX System" is deemed "substantially equivalent" to legally marketed predicate devices for the quantitative measurement of Sodium, Potassium, Chloride, and Carbon Dioxide in human serum samples on the Beckman CX System, for the diagnosis and treatment of electrolyte disorders. The letter does not contain the detailed technical study results, acceptance criteria, or methodological specifics of the performance evaluation that led to this determination.
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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
65 2724
§ 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.