(64 days)
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Not In Text
No
The provided text does not contain any mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The "Intended Use" states that the device is "useful in the prevention of coronary heart disease," which implies a prophylactic rather than a therapeutic function.
Yes
The device is described as useful in the "prevention of coronary heart disease" and mentions the association of "increased dietary fats and cholesterol" with "atherosclerosis." This suggests it is used to measure or analyze parameters related to these conditions, which falls under the scope of diagnosis or risk assessment.
No
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The name "SPIFE 2000/3000 Lipoprotein System" suggests it might be a hardware system for analyzing lipoproteins.
Based on the provided information, the SPIFE 2000/3000 Lipoprotein System is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's "useful in the prevention of coronary heart disease" by analyzing factors associated with atherosclerosis (increased dietary fats and cholesterol). This strongly suggests it's used to analyze biological samples (like blood) to provide information about a patient's health status or risk.
- Lipoprotein System: Lipoproteins are components found in blood. A "Lipoprotein System" is a strong indicator that the device is designed to measure or analyze these components.
- Context of Atherosclerosis and Cardiovascular Disease: The connection to these conditions further supports the idea that the device is used for diagnostic or risk assessment purposes based on biological samples.
While the "Device Description" is missing, the "Intended Use" alone provides enough information to classify it as likely an IVD. IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The analysis of lipoproteins for the prevention of coronary heart disease fits this definition.
N/A
Intended Use / Indications for Use
The SPIFE 2000/3000 Lipoprotein System is useful in the prevention of coronary heart disease. Increased dietary fats and cholesterol lead to atherosclerosis which leads to cardiovascular disease and strokes.
Product codes
JHO
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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§ 862.1475 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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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Ms. Patricia Franks Assistant Director of Regulatory Affairs Helena Laboratories, Inc. P.O. Box 752 1530 Lindbergh Drive Beaumont, TX 77704-0752
Re: K013466
Trade/Device Name: Spife 2000/3000 Lipoprotein System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, reserved Product Code: JHO Dated: October 17, 2001 Received: October 18, 2001
Dear Ms. Franks:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and i additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known):
SPIFE 2000/3000 Lipoprotein System Device Name:
Indications for Use:
The SPIFE 2000/3000 Lipoprotein System is useful in the prevention ine of Ira 2000/3000 Expopulary heart disease. Increased dietary fats and ana decocio. Or oto atherosclerosis which leads to cardiovascular disease and strokes.
Heim Coogan
(Division Sign-Off)
Division of Clinical Laboratory Devices
(Division
510(k) No.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺳﺎ Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)