(18 days)
Not Found
No
The device description details a chemical assay based on enzymatic reactions and photometric measurement, with no mention of AI or ML algorithms for data processing or interpretation.
No
This device is an in-vitro diagnostic assay used for the quantitative determination of HDL-C, which aids in diagnosis and treatment monitoring, but does not directly provide therapy.
Yes
The document explicitly states that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders". The device performs such measurements.
No
The device description clearly outlines a chemical assay involving reagents and enzymatic reactions, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma". The term "in-vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory test that analyzes biological samples (serum and plasma) using chemical reactions to measure a specific analyte (HDL-C). This is characteristic of an IVD.
- Purpose: The intended use also states that the measurements are used in the "diagnosis and treatment of lipid disorders... atherosclerosis, and various liver and renal diseases." This indicates the test is used for medical purposes related to diagnosis and treatment, which is the core function of an IVD.
- Care Setting: The intended user is "automated clinical chemistry analyzers," which are instruments used in clinical laboratories for performing in-vitro diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Product codes
LBS
Device Description
The HDL-Cholesterol plus 2nd Generation test principle uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The cholesterol concentration of HDL-cholesterol is determined enzymatically by cholesterol esterase and cholesterol oxidase coupled with PEG. The color intensity of the blue quinoneimine dye formed is directly proportional to the HDL-cholesterol concentration and is measured photometrically.
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): 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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC - 5 2003
510(k) Summary - HDL-Cholesterol plus 2nd generation
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3831 |
Contact person: Sherri L. Coenen
Date prepared: November 12, 2003 |
| Device Name | Proprietary name: HDL-Cholesterol plus 2nd generation
Common name: HDL-Cholesterol Assay
Classification name: LDL and VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL |
| Device description | The HDL-Cholesterol plus 2nd Generation test principle uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The cholesterol concentration of HDL-cholesterol is determined enzymatically by cholesterol esterase and cholesterol oxidase coupled with PEG. The color intensity of the blue quinoneimine dye formed is directly proportional to the HDL-cholesterol concentration and is measured photometrically. |
| Intended use | HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers. |
| Predicate Device | We claim substantial equivalence to the currently marketed HDL Cholesterol plus Assay. (K000568). |
1
510(k) Summary - HDL-Cholesterol plus 2nd generation,
continued
Reagent Summary The following table describes the similarities and differences between the HDL-Cholesterol plus 2nd generation and the predicate device.
| Topic | HDL-C plus
(K000568) | HDL-Cholesterol plus 2nd
generation
(Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the direct quantitative
determination of high-density
lipoprotein cholesterol (HDL-
cholesterol) in serum and plasma. | HDL-C plus 2nd generation is an
enzymatic in-vitro assay for the direct
quantitative determination of high-
density lipoprotein cholesterol (HDL-
C) in human serum and plasma on
automated clinical chemistry
analyzers. |
| Method | Homogeneous enzymatic
colorimetric | Same |
| Sample type | Serum
Li-, Na-Heparin plasma
EDTA plasma | Serum
Li-, Na-, NH4- Heparin plasma
EDTA plasma |
| Measuring
range | 3 - 120 mg/dl | Same |
| Expected
values | National Cholesterol Education
Program (NCEP) guidelines:
60 mg/dL High HDL Cholesterol
(negative risk factor for CHD) | National Cholesterol Education
Program (NCEP) guidelines:
Trade/Device Name: HDL-Cholesterol plus 2nd generation Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: November 12, 2003 Received: November 17, 2003
Dear Ms. Coenen:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): Mit Ko3 3610
Device Name: HDL-Cholesterol plus 2nd generation
Indications For Use:
HDL-C plus 2nd generation is an enzymatic in-vitro assay for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on automated clinical chemistry analyzers.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Carol C Benam/Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033610
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)