(127 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
This device is for in vitro diagnostic use, meaning it analyzes samples outside the body, rather than directly treating a patient. Its purpose is to measure LDL cholesterol for diagnosis and treatment of conditions, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states "For IN VITRO diagnostic use" and mentions that LDL cholesterol measurements are used "in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This indicates its role in diagnosing medical conditions.
No
The intended use clearly states "For IN VITRO diagnostic use" and describes a "lipoprotein test system" intended to measure lipoprotein in serum. This strongly implies a physical device that interacts with a biological sample, not a software-only device. The lack of a device description further supports this interpretation as it would be expected to describe the software if it were the primary component.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For the quantitative determination of low 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 IVD classification.
- "A lipoprotein test system is a device intended to measure lipoprotein in serum." This further clarifies its function as a test system for analyzing a biological sample.
- "Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders..." This describes the diagnostic purpose of the measurements obtained by the device.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of disease.
N/A
Intended Use / Indications for Use
For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use.
A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
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
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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.)
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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.
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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.
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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).
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§ 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
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
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 C1E 2A6
K041927 Re:
Trade/Device Name: LDL-ADVANCE Assay, Cat. No. 279-20,279-40 Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR 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) remarket 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. Lorks
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
K041927 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
LDL-ADVANCE Assay, Cat. No. 279-20, 279-40 Device Name:
Indications for Use:
For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use.
A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
| Prescription Use: | |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| And/or | |
| Over-the-Counter Use (OTC): | |
| (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 Bener
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K041927