(275 days)
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No
The summary describes a quantitative in vitro diagnostic test for Lipoprotein(a) using immunoturbidimetry on a specific instrument. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No.
The device is used for in vitro diagnostic determination of Lipoprotein(a) in human serum and plasma for diagnostic purposes, not for treating any condition.
Yes
The intended use explicitly states "may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases" and multiple sections indicate it is "For in vitro diagnostic use".
No
The intended use clearly describes the device as an in vitro diagnostic (IVD) reagent (calibrator and control) used with a specific instrument (T60). This indicates a physical component (reagent) and reliance on hardware (T60 instrument), not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document repeatedly states "For in vitro diagnostic use".
- Intended Use: The intended use is for the "in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma". This clearly indicates testing of samples taken from the human body outside of the body.
- Purpose: The measurement of Lipoprotein(a) is stated to "aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases". This is a diagnostic purpose.
- Components: The document describes a calibrator and controls, which are common components of IVD test kits used for accurate measurement and quality control.
N/A
Intended Use / Indications for Use
For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.
Product codes
DFC, JIT, JJY
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.)
Not Found
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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§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
0
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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 7 2007
Thermo Electron Oy c/o Mr. Päivi Sormunen Vice President of Industrial Solutions and QRC Ratastie 2, P.O. Box 100 Vantaa, Finland 01621
K063838 Trade Name: Lipoprotein(a), Lipoprotein(a) Calibrator, Lipoprotein(a) Control, Lipoprotein(a) Control High Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system. Regulatory Class: Class II Product Code: DFC, JIT, JJY Dated: September 19, 2007 Received: September 21, 2007
Dear Mr. Sormunen:
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 10(x) 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) 276-0490. Also, please othe 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 tolloffree no (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Séan M. Cooper, M.S., 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): K063838
Device Names:
Lipoprotein(a) Lipoprotein(a) Calibrator Lipoprotein(a) Control Lipoprotein(a) Control High
Indications for Use:
For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments.
Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases
Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy
For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy
For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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 |
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