(73 days)
- The Thermo Electron Infinity™ ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher`s disease, a hereditary disorder affecting the spleen.
- The Thermo Electron Infinity™ ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only.
- The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.
Not Found
This document is a 510(k) premarket notification for in vitro diagnostic devices. It does not contain information about an AI/ML-based device or a study that uses acceptance criteria and device performance as typically understood for AI/ML or imaging devices. The devices described are reagent kits, calibrators, and controls for measuring Angiotensin Converting Enzyme (ACE) in human serum or plasma.
Therefore, I cannot extract the requested information from the provided text as it is not relevant to AI/ML or imaging device studies.
However, if this were an AI/ML or imaging device submission, the requested information would typically be found in sections detailing clinical study results, performance validation, or substantial equivalence comparisons, which are absent in this specific document.
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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 three lines forming its body and wings. The eagle is facing to the right. 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
Bola Nicholson MT (ASCP) Technical Manager Thermo Electron Corp. 331 South 104th Street Louisville, CO 80027
K041657 Re:
Ko+1077
Trade/Device Name: Thermo Electron Infinity™ Angiotensin Converting Enzyme (ACE) Reagent Kit-Thermo Electron Infinity™ Angiotensin Converting Enzyme (ACE) Calibrator Thermo Electron Infinity™ Angiotensin Converting Enzyme (ACE) Normal and Elevated Controls Regulation Number: 21 CFR 862.1090 Regulation Name: Angiotensin converting enzyme (A.C.E.) test system Regulatory Class: Class II Product Code: KQN, JIS, JJX
AUG 3 0 2004
Dated: June 18, 2004 Received: June 18, 2004
Dear Ms.Nicholson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sualed in the energent 976, 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). and Oosmetter For (100) has the device, subject to the general controls provisions of the Act. The r ou may, aron's provisions of the Act include requirements for annual registration, listing of general oonarols profice, 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 your device is easilified (divinal controls. Existing major regulations affecting your device it may be subjoct to bach adde 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 I Toast of advised that I Dril beather over device complies with other requirements of the Act that I DT has made a aother and regulations administered by other Federal agencies. You must or any I cataled and 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 CFR Part 807), advertis 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) This letter with anow you to begin mating of substantial equivalence of your device to a legally prematicated 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, If you destions on the promotion and advertising of your-device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In 7 th o Diagliosate Do reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou inay oodain other generarers, 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper US, DVM.
Tean M. Cooper, MS, 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): K041657
Device Name:
- vice Name:
- Thermo Electron Infinity™ Angiotensin Converting Enzyme (ACE) Reagent Kit.
-
- Thermo Electron Infinity™ Angiotensin Converting Enzyme (ACE) Calibrator.
-
- Thermo Electron Infinity™ Angiotensin Converting Enzyme (ACE) Normal and Elevated Controls.
Indications For Use:
- Cations For OSC.
- The Thermo Electron Infinity™ ACE Reagent Kit is intended for the rite Thermination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher`s disease, a hereditary disorder affecting the spleen.
-
- The Thermo Electron Infinity™ ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only.
-
- The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 807 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)
Carol C Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
510(k) K041657
§ 862.1090 Angiotensin converting enzyme (A.C.E.) test system.
(a)
Identification. An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.