(18 days)
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.
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.
This is a 510(k) summary for a medical device, which generally does not include the detailed study design elements you've requested (such as sample size, ground truth establishment methods, or expert qualifications for test/training sets). The primary purpose of a 510(k) summary is to demonstrate "substantial equivalence" to a predicate device, focusing on performance characteristics and how they compare.
However, I can extract the information that is present and provide a table for acceptance criteria and device performance based on the available text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity. Instead, it describes key performance characteristics and compares them to the predicate device, implying that meeting or being comparable to the predicate's performance is the implicit acceptance criterion for substantial equivalence.
| Performance Characteristic | Predicate Device (HDL-C plus - K000568) (Implicit Acceptance Criteria) | Modified Device (HDL-Cholesterol plus 2nd generation) (Reported Device Performance) |
|---|---|---|
| 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 |
| Formulation R1 | Sulfated alpha-cyclodextrin, dextran sulfate, magnesium chloride, HSDA, ascorbate oxidase (Acremonium), peroxidase (horseradish), MOPS buffer, preservative | Dextran sulfate, magnesium sulfate heptahydrate, HSDA, ascorbate oxidase (Eupenicillium sp., recombinant), peroxidase (horseradish), MOPS buffer, preservative |
| Formulation R2 | PEG cholesterol esterase (Pseudomonas), PEG cholesterol oxidase (Pseudomonas), peroxidase (horseradish), 4-aminophenazone, PIPES buffer, preservative | PEG cholesterol esterase (Pseudomonas), PEG cholesterol oxidase (Streptomyces sp., recombinant) peroxidase (horseradish), 4-amino-antipyrine, PIPES buffer, preservative |
Notes on Acceptance Criteria: The primary acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This means the new device must be as safe and effective as the predicate. In this context, "performance" refers to demonstrating that the modified device functions comparably in its intended use, measuring range, method, and sample types, despite minor formulation changes. The NCEP guidelines for expected values are provided as context for interpretation, not as a direct performance metric for the device itself.
2. Sample size used for the test set and the data provenance:
- The 510(k) summary does not provide details on sample sizes for any test sets.
- Data provenance is not explicitly mentioned, but given it's a product from Roche Diagnostics Corporation (Indianapolis, IN, USA), it's highly probable that the studies were conducted in the US. The summary does not specify if data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. For an in-vitro diagnostic (IVD) like an HDL-Cholesterol assay, ground truth is typically established by reference methods or validated laboratory measurements, not by expert interpretation in the same way as, for example, a medical imaging device. However, the document does not detail how "ground truth" (i.e., true HDL-C values for comparison) was established for any validation studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable or provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading by multiple experts). For a quantitative IVD, the "adjudication" would be based on the objective comparison of the device's results to a reference method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable or provided. MRMC studies are specific to devices that assist human readers (e.g., AI-powered diagnostic software). This device is a direct quantitative assay, not an assistive reading device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device, an enzymatic in-vitro assay, inherently functions as a "standalone" measurement system. It directly produces a quantitative result (HDL-C concentration) without requiring human interpretation beyond standard laboratory procedures and clinical context. The entire device's performance would be considered standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The 510(k) summary does not explicitly state the type of ground truth used for performance comparison. For quantitative IVDs, ground truth is usually established using:
- Reference methods: Highly accurate and precise laboratory methods, often more complex or expensive than routine assays.
- Calibrators and controls: Materials with known and certified concentrations of the analyte.
- Patient samples compared against the predicate device or a clinical gold standard.
8. The sample size for the training set:
- This information is not provided and is generally not applicable in the context of an enzymatic chemical assay. These assays rely on validated chemical reactions, not machine learning algorithms that require "training sets" in the conventional sense.
9. How the ground truth for the training set was established:
- This information is not provided and not applicable as there is no "training set" in the context of this type of enzymatic assay.
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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 Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831Contact person: Sherri L. CoenenDate prepared: November 12, 2003 |
| Device Name | Proprietary name: HDL-Cholesterol plus 2nd generationCommon name: HDL-Cholesterol AssayClassification 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). |
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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 2ndgeneration(Modified Device) |
|---|---|---|
| Intended Use | For the direct quantitativedetermination of high-densitylipoprotein cholesterol (HDL-cholesterol) in serum and plasma. | HDL-C plus 2nd generation is anenzymatic in-vitro assay for the directquantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma onautomated clinical chemistryanalyzers. |
| Method | Homogeneous enzymaticcolorimetric | Same |
| Sample type | SerumLi-, Na-Heparin plasmaEDTA plasma | SerumLi-, Na-, NH4- Heparin plasmaEDTA plasma |
| Measuringrange | 3 - 120 mg/dl | Same |
| Expectedvalues | National Cholesterol EducationProgram (NCEP) guidelines:< 35 mg/dL : low HDL Cholesterol(major risk factor for CHD)> 60 mg/dL High HDL Cholesterol(negative risk factor for CHD) | National Cholesterol EducationProgram (NCEP) guidelines:< 40 mg/dL : low HDL Cholesterol(major risk factor for CHD)≥ 60 mg/dL High HDL Cholesterol(negative risk factor for CHD) |
| FormulationR1 | Sulfated alpha-cyclodextrin, dextransulfate, magnesium chloride, HSDA,ascorbate oxidase (Acremonium),peroxidase (horseradish), MOPSbuffer, preservative | Dextran sulfate, magnesium sulfateheptahydrate, HSDA, ascorbateoxidase (Eupenicillium sp.,recombinant), peroxidase(horseradish), MOPS buffer,preservative |
| FormulationR2 | PEG cholesterol esterase(Pseudomonas), PEG cholesteroloxidase (Pseudomonas), peroxidase(horseradish), 4-aminophenazone,PIPES buffer, preservative | PEG cholesterol esterase(Pseudomonas), PEG cholesteroloxidase (Streptomyces sp.,recombinant) peroxidase(horseradish), 4-amino-antipyrine,PIPES buffer, preservative |
:
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 5 2003
Ms. Sherri L. Coenen Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K033610
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).
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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
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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)
§ 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.