(127 days)
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No
The provided text describes an in vitro diagnostic device for measuring cholesterol fractions and does not mention any AI or ML components or functionalities.
No
This device is for in vitro diagnostic use, specifically for quantitative determination of lipoprotein fractions in serum, which is a diagnostic rather than therapeutic function.
Yes
The intended use explicitly states "For IN VITRO diagnostic use" and describes the quantitative determination of cholesterol fractions in serum, which is a diagnostic measurement.
No
The 510(k) summary describes a calibrator for in vitro diagnostic assays, which is a physical substance used to calibrate laboratory equipment. It is not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For the quantitative determination of low and density lipoprotein fractions of cholesterol in serum." This indicates the device is used to analyze a biological sample (serum) outside of the body.
- "For IN VITRO diagnostic use." This is a direct statement confirming its intended use as an in vitro diagnostic device.
- "HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum." This further clarifies its role in the diagnostic process, specifically for calibrating assays that measure cholesterol in serum.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of low and density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use.
HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.
Product codes
JIX
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
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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
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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.
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 (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three lines forming a wing-like shape, and the overall design is simple and monochromatic.
Public Health Service
NOV 2 3 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Olscamp Regulatory Affairs Coordinator, External Diagnostics Chemical Limited 16 McCarville Street Charlottetown, PE Canada CIE 2A6
Re: K041926
Trade/Device Name: HDL/ LDL-ADVANCE Calibrator, Cat. No. SE-278 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 13, 2004 Received: October 14, 2004
Dear Ms. Olscamp:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
sincerely yours,
Cornelia B. Loks
Cornelia B. Rooks, MA 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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INDICATIONS FOR USE
______________________________________________________________________________________________________________________________________________________________________________ K041926 510(k) Number:
HDL/LDL-ADVANCE Calibrator, Cat. No. SE-278 Device Name:
Indications for Use:
For the quantitative determination of low and density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use.
HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.
구 Prescription Use: ____ And/or Over-the-Counter Use (OTC): __________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
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
Bidder Sign Off
Division Sign-Off
e of In Vitro Diagnos e Evaluation and Safety
510(k) Ko 41926