(66 days)
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No
The description focuses on a chemical precipitation method for laboratory analysis and does not mention any computational or algorithmic components indicative of AI/ML.
No
This device is for in vitro diagnostic use, specifically for quantitatively determining HDL-Cholesterol in serum, which does not constitute a therapeutic intervention.
Yes
This device is described as being "For the quantitative determination of HDL-Cholesterol in serum. For IN VITRO diagnostic use," which directly indicates its purpose as a diagnostic tool.
No
The device description clearly states it is a procedure for HDL-Cholesterol precipitation using chemical reagents (dextran sulfate and magnesium ions), indicating it is a laboratory assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For IN VITRO diagnostic use." This is the primary indicator that the device is intended for use outside of the body to diagnose or detect a disease or condition.
N/A
Intended Use / Indications for Use
For the quantitative determination of HDL-Cholesterol in serum. For IN VITRO diagnostic use.
Product codes
LBR
Device Description
The procedure for HDL-Cholesterol precipitation in this formulation is based on the recommendations of Warnick, et.al. (2) and uses dextran sulfate and magnesium ions to precipitate the LDL and VLDL fractions.
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
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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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 7 1998
Karen Callbeck, R.T.B.Sc. . Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0
Re : K980772 HDL Cholesterol Precipitating Reagent Cataloque No. 205-51 Regulatory Class: I Product Code: LBR Dated: February 17, 1998 Received: February 20, 1998
Dear Ms. Callbeck:
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, 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), Jit may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ 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/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
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K980772 |
| Device Name: | HDI UNI-PAKS |
Indications For Use:
Cat. No./Réf./Ref. Nº: 205-51 (100 Tubes)
For the quantitative determination of HDL-Cholesterol in serum.
For IN VITRO diagnostic use.
Barr, et.al. ( ) in 1951 first reported the inverse relationship between high density lipoproteins (HDL) and coronary heart disease. Since that time several procedures have been used to separate HDL including ultracentrifugation, electrophoresis and precipitation. With the precipitation methods (heparin/manganese, dextran sulfate/magnesium, phosphotungstate/magnesium, polyethylene glycol) the very low density lipoproteins (VLDL) and the low density lipoproteins (LDL) are selectively precipitated and the supernatant containing the HDL is removed. Cholesterol concentration in the supernatant is assayed to determine HDL-Cholesterol concentration using an enzymatic total cholesterol procedure. The procedure for HDL-Cholesterol precipitation in this formulation is based on the recommendations of Warnick, et.al. (2) and uses dextran sulfate and magnesium ions to precipitate the LDL and VLDL fractions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980646
K980772
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)