(98 days)
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Not Found
No
The summary describes a reagent set for a laboratory test and contains no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) tool used for the quantitative determination of LDL-C in human serum or plasma. It is used to identify patients at higher risk for coronary heart disease but does not actively treat or mitigate a disease or condition.
Yes
The device is described as being for "in vitro diagnostic use only" and its purpose is the "quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma," which is a "useful tool in identifying patients who are at a higher risk for coronary heart disease." These statements indicate its use in diagnosing or identifying risk for a medical condition.
No
The 510(k) summary describes a reagent set for in vitro diagnostic use, which is a chemical product, not a software-only medical device.
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 statement, along with the description of the device's purpose (quantitative determination of LDL-C in human serum or plasma for identifying patients at higher risk for coronary heart disease), clearly indicates that it is designed to be used outside of the body to diagnose or aid in the diagnosis of a medical condition.
N/A
Intended Use / Indications for Use
For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Product codes
MRR
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
Not Found
Intended User / Care Setting
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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
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Key Metrics
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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
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Image /page/0/Picture/3 description: The image shows the date August 8, 2005. The month is represented by the abbreviation AUG. The day is the number 8, and the year is 2005. The date is written in a simple, clear font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jian Vaeches Official FDA Coorespondent TECO Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807
Re: K051121
Trade/Device Name: Direct LDL Cholesterol Reagent Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR Dated: July 15, 2005 Received: July 15, 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,
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
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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): K051121
Device Name: Direct LDL Cholesterol Reagent
Indications For Use: For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Prescription Use _√
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)
K
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K05 1121