(88 days)
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Not Found
No
The summary describes a standard in vitro diagnostic test for HDL-Cholesterol and contains no mention of AI or ML.
No
The device is an in vitro diagnostic procedure intended for the quantitative determination of HDL-cholesterol in serum, used for diagnosis and treatment of lipid disorders, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the procedure is "intended for Invitro Diagnostic use" and that "Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders".
No
The intended use describes an in vitro diagnostic procedure for determining HDL-cholesterol in serum, which typically involves laboratory equipment and reagents, not just software. The lack of a device description further supports this conclusion.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) in serum."
This statement directly identifies the device's purpose as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.
Product codes
LBS
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the 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 intertwined strands and a base that resembles flowing fabric. The overall design is simple and conveys the organization's focus on health and human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 10 1999
A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, Connecticut 06606
Re: K991665
Trade Name: HDL-CHOLESTEROL Regulatory Class: I reserved Product Code: LBS Dated: July 12, 1999 Received: July 26, 1999
Dear Mr. Leon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".
Sincerely yours,
steven Sutman
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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510 (k) NUMBER (IF KNOWN): K991665
DEVICE NAME: HDL-CHOLESTEROL
INDICATIONS FOR USE:
This HDL-Cholesterol procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of high-density lipoprotein-cholesterol (HDL) in serum. Lipoproteins measurements are use in the diagnosis and treatment of lipid disorders(such as diabetes melitus), artherosclerosis and various liver and renal diseases.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory evices
510(k) Number K991665
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (OED)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter-Use (Optional Format 1-2-96)