(62 days)
Not Found
None
No
The summary describes a device for quantitative determination of HDL cholesterol, a standard laboratory test. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description (though not found in this excerpt) point towards a traditional laboratory analyzer.
No
The device is used for quantitative determination of HDL cholesterol as a risk factor, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as being for "quantitative determination of high density lipoprotein (HDL) cholesterol in human serum as a risk factor in coronary artery disease," which directly relates to diagnosing or assessing risk for a medical condition.
Unknown
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 intended use describes a laboratory test, which could be performed by a software-controlled instrument or a manual process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of high density lipoprotein (HDL) cholesterol in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to provide information about a health condition (risk factor in coronary artery disease).
- Care Setting: The intended users are "clinical laboratories and physicians' office laboratories," which are typical settings for performing in vitro diagnostic tests.
These points align directly with the definition of an IVD, which is a medical device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
For use in clinical laboratories and physicians' office laboratories for quantitative determination of high density lipoprotein (HDL) cholesterol in human serum as a risk factor in coronary artery disease.
Product codes
JHM, LBR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories and physicians' office laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 2 1997
Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 23 Cosby Drive Bedford, Massachusetts 01730-1401
Re : K973988 RDI Homogeneous HDL Cholesterol Test Requlatory Class: I Product Code: JHM, LBR Dated: October 20, 1997 Received: October 21, 1997
Dear Dr. Lawlor:
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 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, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.
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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 requlation (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/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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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[X-1]
INDICATIONS FOR USE
Page 1 of 1
K9 13988
510(k) Number (if known):
Device Name: RDI Homogeneous HDL Cholesterol Test
Indications For Use:
For use in clinical laboratories and physicians' office laboratories for quantitative determination of high density lipoprotein (HDL) cholesterol in human serum as a risk factor in coronary artery disease.
V.M. Grantt for M. Montgomery
(Division Sign-Off)
Division of Clima
evices
510(k) Number K97 3998
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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