(56 days)
Not Found
Not Found
No
The summary describes a chemical reagent for laboratory testing and contains no mention of AI or ML.
No
The device is a reagent used for diagnostic purposes (separation of HDL for coronary heart disease prediction), not for treating or preventing a disease.
Yes
The device is used to separate HDL from other serum lipoproteins, which provides "valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations." This indicates its use in aiding in the diagnosis of a disease.
No
The device description is not found, but the intended use describes a "Precipitating Reagent," which is a chemical substance used in laboratory testing. This indicates a physical component, not a software-only device.
Based on the provided information, the device described is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the reagent is used for the "separation of HDL from other serum lipoproteins" and provides information for the "prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations." This involves testing a sample (serum) taken from the human body to provide information about a health condition.
- Nature of the Device: A "precipitating reagent" is a chemical substance used in laboratory procedures to cause a substance to separate out of a solution. This is a typical component used in in vitro diagnostic tests.
While the "Device Description" is not found, the intended use and the nature of the reagent strongly suggest it is used in a laboratory setting to perform a test on a biological sample outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.
Product codes
LBS
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
Not Found
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 and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 5 1998
Charles C. Allain, Ph.D. . AC Biochemicals, Inc. 17955 Sky Park Circle, Suite J Irvine, California 92614
K982539 Re : HDLC Precipitating Reagent Requlatory Class: I Product Code: LBS Dated: July 14, 1998 Received: July 21, 1998
Dear Dr. Allain:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 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/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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
2
510(k) K964917:
ﻣﺤﻤﺪ ﺳ
Device Name: HDLC Precipitating Reagent
Indications For Use:
The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 12 982539
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use Use
| (Per 21 CFR 801.109) |
|---|
| ---------------------------------------------- |
OR
Over-The-Counter