(117 days)
Not Found
No
The summary describes a calibrator and reagent set for in vitro diagnostic testing, with no mention of AI or ML technology.
No.
The device is a calibrator and reagent set for in vitro diagnostic use, intended for the quantitative determination of HDL cholesterol, which helps identify patients at risk for coronary heart diseases. It does not directly treat or prevent a disease, but rather aids in diagnosis.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is used for the "quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma" and that "HDL quantitative determination is used in identifying patients who are at a higher risk for coronary heart diseases." This clearly indicates a diagnostic purpose.
No
The device description explicitly mentions "Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator," which are physical components (reagents and calibrators) used in in vitro diagnostics, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This reagent set is intended for in vitro diagnostic use only." This is a clear indication that the device is designed to be used outside of the body to examine specimens from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
Teco Direct HDL/LDL calibrator is intended for use in calibration of Teco Diagnostics' Direct HDL and LDL Cholesterol Reagent for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL quantitation is used in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JIS, LBR
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.
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
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has its head turned to the left.
JUL 26 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jian Vaeches Official FDA Correspondent TECO Diagnostics 1268 N. Lakeview Avenue Anaheim CA 92807
K050823 Re:
K050623
Trade/Device Name: Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS, LBR Dated: July 15, 2005 Received: July 15, 2005
Dear Ms. Vaeches:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) 70 ttg 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 r ou may a 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 rease be actised 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) I ms letter will anon you to bogin twating of substantial equivalence of your device to a legally premarket notification. "The PDs 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 destre specific infortion and advertising of your device, please contact the Office of In of questions on the promountion and Safety at (240) 276-0484. Also, please note the VINO Dugliostic Device Dradian by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outline of Senall 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. Benem
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
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TECO DIAGNOSTICS
Image /page/2/Picture/1 description: The image shows a black hexagon with the letters 'TC' in white inside. The letters are in a simple, sans-serif font and are stacked on top of each other. The overall design is simple and graphic, suggesting a logo or symbol.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com_Email:tecodiag@tecodiag.com
Indications for Use
510(k) Number (if known):__Unknown at this time K 0 323
Device Name: Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator
Indications For Use: Teco Direct HDLADL Calibration of Teco Diagnostics' Direct HDL and In aroutlorio For DOC Yood Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the Direct LDC onvestern Reagent oo in Solan Ui pprotein cholesterol (HDL-C) in human serum or plasma. HDL quantialive decemination of mgn dontiny in dentifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. 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)
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safet
510(k) K050823