(365 days)
Not Found
No
The device description and performance studies focus on enzymatic and chemical reactions for quantitative determination of analytes, with no mention of AI or ML.
No
This device is a reagent kit used for the quantitative determination of cholesterol and triglycerides in human serum, intended for diagnosis and treatment decisions, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent kits are "intended for the quantitative determination" of various substances (Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides) and that these measurements "are used in the diagnosis and treatment of disorders." This directly indicates a diagnostic purpose.
No
The device description clearly outlines a reagent kit utilizing enzymatic methods and chemical reactions to determine cholesterol levels, indicating a hardware component (the reagents) is central to its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagent kits are for the "quantitative determination" of various analytes (Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides) in "human serum." It also explicitly mentions that these measurements are "used in the diagnosis and treatment" of various diseases and disorders. This aligns directly with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description: The description details the enzymatic methods used to analyze the components in the serum samples. This is a typical characteristic of IVD reagents used in clinical laboratory settings.
- Intended User / Care Setting: The intended user is "Clinical labs," which is where IVD testing is performed.
- Performance Studies: The document describes various performance studies (Accuracy, Precision, Linearity, Analytical Specificity, Detection Limit, Stability) that are standard for validating the performance of IVD devices.
- Key Metrics: The key metrics provided (Sensitivity, Precision, Method comparison, Linearity) are all relevant to evaluating the performance of an IVD.
- Predicate Device(s): The mention of predicate devices with K numbers indicates that this device is being compared to previously cleared IVDs.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.
HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Product codes (comma separated list FDA assigned to the subject device)
CHH, LBS, MRR, CDT
Device Description
CHOLESTEROL: Reagent kit. Reagent Composition: 4-Chlorophenol (4.7 mM), 4-Aminoantipyrine (1 mM), Cholesterol esterase (CHE) (>= 500 U/L), Cholesterol oxidase (CHOD) (>= 500 U/L), Peroxidase (POD) (>= 1000 U/L). The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample.
HDL-Cholesterol: Reagent kit. Reagent Composition R1: Cholesterol oxidase ( 5000 U/L, Glycerokinase: > 1000 U/L, Lipoprotein Lipase: > 15000 U/L, ATP: 4.5 mM, TOOS: 4.8 mM, Non-reactive ingredients, preservative. Reagent Composition R2: 4-Aminoantipyrine: 55000 U/L, Non-reactive ingredients, preservative. The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.
All reagents are intended for use with Diatron Pictus®500 Analyzers.
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 labs
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
A precision evaluation study procedure was applied for one site and one analyzer in a standard 20x2x2 experiment. Three human serum pools were tested for CHOLESTEROL and TRIGLYCERIDES, two pools for HDL-Cholesterol and four pools for LDL-Cholesterol, near the Medical Decision Limits, for every analyte. The protocol uses measurements of each sample for 20 testing days, two different runs, and two replicate measurements per run (morning and afternoon run) for a total of 80 results per level concentration.
For linearity studies, for each analyte, 11 to 13 levels were prepared by dilution of a human serum pool with a concentration of analyte higher than the claimed upper limit of linearity. The human serum high pool was prepared from a human base pool after spiking with a purified concentrated analyte. The diluent was a delipidized commercial preparation free of each analyte. The samples were assigned their reference values arithmetically from serial dilutions of the high-level sample. Each level was tested in 4 replicates using 1 instrument, and 3 Lots of reagents. Sample included target MDLs within the range tested.
For interference studies, 2 concentration levels of analytes (low and high) were used. Serum pools at low and high levels of each analyte were prepared, then spiked with the interference compounds. For endogenous interference, low and high levels of each analyte were spiked with a recommended concentration of endogenous substance from CLSI EP37. For exogenous interference, two different drug concentrations were studied: the highest drug concentration under therapeutic treatment and the recommended test concentration in the sample as proposed by CLSI EP-37 protocol or from relative bibliographic data.
For detection limit studies (LoB), 5 blank serum were measured in 4 replicates for 3 days for a total of 60 measurements, with 3 reagent Lots. For LoD, 5 low level samples were measured in 4 replicates for 3 days for a total of 60 measurements, with 3 reagent Lots. For LoQ, 10 samples that span the low end of linearity were measured 5 times each day for a total of 150 measurements in 3 days with 3 Reagent Lots.
For method comparison, a minimum of 75 left over specimens, spanning the dynamic ranges, were assayed in singleton and in a blinded fashion on the candidate and predicate systems. Between 93-162 human serum samples were tested in a single measurement on the candidate and predicate systems using at least three lots of Medicon Hellas reagents. Less than 10% of samples were spiked or diluted to cover the analytical measurement ranges.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility: Precision studies were conducted according to CLSI EP05-A3 guideline, using a 20x2x2 experiment.
For CHOLESTEROL: N=80 samples per pool (3 pools). Total precision %CV: 2.2% (92 mg/dL), 2.8% (241 mg/dL), 3.0% (345 mg/dL).
For HDL-Cholesterol: N=80 samples per pool (2 pools). Total precision %CV: 3.8% (31 mg/dL), 2.6% (57 mg/dL).
For LDL-Cholesterol: N=80 samples per pool (4 pools). Total precision %CV: 3.9% (98 mg/dL), 3.5% (126 mg/dL), 3.6% (156 mg/dL), 3.2% (193 mg/dL).
For TRIGLYCERIDES: N=80 samples per pool (3 pools). Total precision %CV: 2.1% (41 mg/dL), 3.0% (148 mg/dL), 1.8% (399 mg/dL).
Linearity: Linearity studies were conducted according to CLSI EP06-EdA2 guideline.
CHOLESTEROL: Slope=1.001, Intercept=0.409, R2=0.9997 for range 20 – 700 mg/dL.
HDL-Cholesterol: Slope=1.033, Intercept=-0.668, R2=0.9984 for range 6 – 200 mg/dL.
LDL-Cholesterol: Slope=1.099, Intercept=-0.40, R2=0.9996 for range 3 – 800 mg/dL.
TRIGLYCERIDES: Slope=0.978, Intercept=-0.236, R2=0.9994 for range 10 – 1000 mg/dL.
Analytical Specificity / Interference: Interference studies were conducted according to CLSI EP07-A3 guideline.
Endogenous interference:
CHOLESTEROL, HDL-Cholesterol, LDL-Cholesterol: Hemoglobin up to 1000 mg/dL (Cholesterol 500 mg/dL), Conjugated Bilirubin up to 40 mg/dL, Unconjugated Bilirubin up to 40 mg/dL, Triglycerides up to 1500 mg/dL (Cholesterol 1500 mg/dL).
TRIGLYCERIDES: Hemoglobin up to 400 mg/dL, Conjugated Bilirubin up to 40 mg/dL, Unconjugated Bilirubin up to 40 mg/dL.
Exogenous interference: Various substances like Acetaminophen, Acetylsalicylic Acid, Ampicillin, Ascorbic Acid, Atorvastatin, Cefotaxime, Cefoxitin, Cyclosporine, Dipyrone, Dobesilate Calcium, Dobutamine, Doxycycline, Fenofibrate, Heparin, Ibuprofen, Intralipid, Levodopa, Methotrexate, Methyldopa, Metronidazole, N-Acetyl-Cysteine, Phenylbutazone, Pravastatin, Rifampicin, Rosuvastatin, Simvastatin, Theophylline were tested and concentration limits were established for no significant interference (within +/- 10%).
Detection Limit: Studies performed according to CLSI EP17-A2 guideline.
CHOLESTEROL: LoB=2.5 mg/dL, LoD=4.4 mg/dL, LoQ=4.6 mg/dL.
HDL-Cholesterol: LoB=1.0 mg/dL, LoD=3.0 mg/dL, LoQ=5.8 mg/dL.
LDL-Cholesterol: LoB=1.0 mg/dL, LoD=2.0 mg/dL, LoQ=3.0 mg/dL.
TRIGLYCERIDES: LoB=4.0 mg/dL, LoD=5.5 mg/dL, LoQ=9.7 mg/dL.
Stability and Calibration frequency and shelf-life confirmation:
CHOLESTEROL: On-Board Stability 28 days, Calibration Frequency 14 days.
HDL-Cholesterol: On-Board Stability 28 days, Calibration Frequency 28 days.
LDL-Cholesterol: On-Board Stability 28 days, Calibration Frequency At new lot.
TRIGLYCERIDES: On-Board Stability 28 days, Calibration Frequency 28 days.
Method Comparison with Predicate Device:
CHOLESTEROL: N=93, Sample concentration range 44 – 666 mg/dL, Slope=0.9769, Intercept=5.098, R2=0.999.
HDL-Cholesterol: N=141, Sample concentration range 6 – 177 mg/dL, Slope=1.0180, Intercept=-0.028, R2=0.997.
LDL-Cholesterol: N=107, Sample concentration range 5 – 721 mg/dL, Slope=0.9821, Intercept=1.750, R2=0.999.
TRIGLYCERIDES: N=163, Sample concentration range 26 – 975 mg/dL, Slope=0.9774, Intercept=2.041, R2=0.999.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. The document reports LoD and LoQ values.
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.
K925603, K981224, K981303, K063804
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
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2024
Medicon Hellas, S.A. Sotia Mitropoulou Regulatory Affairs Manager Melitona 5-7, 153 44 Gerakas Greece
Re: K232404
Trade/Device Name: CHOLESTEROL: HDL-Cholesterol: LDL-Cholesterol: TRIGLYCERIDES Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (Total) Test System Regulatory Class: Class I, meets the limitations of exemptions 21 CFR 862.9(c)(4) Product Code: CHH, LBS, MRR, CDT Dated: July 9, 2024 Received: July 10, 2024
Dear Sotia Mitropoulou:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
510(k) Number (if known)
Device Name
CHOLESTEROL, HDL-Cholesterol, LDL-Cholesterol, TRIGL YCERIDES
Indications for Use (Describe)
CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.
HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.
LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the logo for "medicon MEDICON HELLAS S.A.". The word "medicon" is in red, and there is a blue line underneath it. The words "MEDICON HELLAS S.A." are in a smaller font and are also in red. The logo is simple and modern.
510(k) Summary
510(k) Number: K232404
This 510(k) safety and effectiveness summary information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
807.92 (a)(1): Name: MEDICON HELLAS S.A. Address: Melitona 5-7, 153 44 Gerakas, Greece Phone: +302.1.0660.6000 FAX: +302.1.0661.2666 Contact: Ms. Sotia Mitropoulou Email: smitropo@mediconsa.com US Agent: Diatron US, Inc. 1.833.228.7931
Mr. Frank Matuszak
frank.matuszak(@diatron.com
All Supplemental testing was performed at the company premises, mentioned above.
807.92 (a)(2): Device name- trade name and common name, and classification
Trade Name: CHOLESTEROL, HDL-Cholesterol, LDL-Cholesterol, and TRIGLYCERIDES.
Common Name: test systems for Cholesterol, HDL, LDL, and Triglycerides for testing human serum.
5
Classification Name(s):
21 CFR § 862.1175 - Cholesterol Test system - Product Code CHH
21 CFR § 862.1475 - HDL-Cholesterol Test system - Product Code LBS
21 CFR § 862.1475 - LDL-Cholesterol Test system - Product Code MRR
21 CFR § 862.1705 - Triglycerides Test system - Product Code CDT
807.92 (a)(3): Identification of the legally marketed predicate devices
Cholesterol - OLYMPUS CHOLESTEROL REAGENT (K925603)
HDL-Cholesterol - DIRECT HDL (K981224)
LDL-Cholesterol - DIRECT LDL (K981303)
Triglycerides - OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804)
Intended Use/Indications for Use:
A) Intended Use(s):
See Indications for Use below.
B) Indications for Use:
CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.
HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
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C) Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D) Special Instrument Requirements:
Diatron Pictus®500 Analyzers
807.92 (a)(4): Device Description
CHOLESTEROL:
BEF 1419-0042 Packaging: 6 x 60 mL
| Reagent Composition: | |
|---|---|
| 4-Chlorophenol | 4.7 mM |
| 4-Aminoantipyrine | 1 mM |
| Cholesterol esterase (CHE) | ≥ 500 U/L |
| Cholesterol oxidase (CHOD) | ≥ 500 U/L |
| Peroxidase (POD) | ≥ 1000 U/L |
The Cholesterol Oxidase peroxidase (CHOD-PAP) enzymatic method is used. The cholesterol esterase enzyme catalyzes the hydrolysis of cholesterol and free fatty and free fatty acids. Free cholesterol, including that originally present in the sample, is then oxidized by the enzyme cholesterol oxidase (CHOD) to cholest-4-en-3-one, by using molecular oxygen as the electron acceptor and concurrently producing hydrogen peroxide (H2O2). The H2O2 produced is then used in a subsequent chromogenic oxidative coupling reaction, catalyzed by the enzyme peroxidase, in the presence of a redox indicator system, which leads to the formation of a colored compound, absorbing light at 550 nm. The increase in absorbance is directly proportional to the cholesterol concentration in the sample.
HDL-Cholesterol:
1419-0240 Packaging: 6 x 13.5 mL (R1) + 6 x 4.5 mL (R2) REF
- REF 1419-0242 Packaging: 6 x 35.1 mL (R1) + 6 x 11.7 mL (R2)
Reagent Composition
| Reagent 1 (R1) | Reagent 2 (R2) |
|---|---|
| Cholesterol oxidase: 5000 U/L | GPO: > 55000 U/L |
| Glycerokinase: > 1000 U/L | Non-reactive ingredients, preservative |
| Lipoprotein Lipase: > 15000 U/L | |
| ATP: 4.5 mM | |
| TOOS: 4.8 mM | |
| Non-reactive ingredients, preservative |
The enzymatic glycerol-3-phosphate-peroxidase (GPO-POD) method is used. The method enzymatically hydrolyzes by lipase to free fatty acids and glycerol is phosphorylated by adenosine triphosphate (ATP) with glycerokinase (GK) to produce glycerol-3-phosphate and adenosine diphosphate (ADP). Glycerol-3-phosphate-oxidase oxidizes glycerol-3-phosphate to dihydroxyacetone phosphate and H2O2. The catalytic action of peroxidase (POD) forms quinoneimine from H202, aminoantipyrine, and Dihydrate (N-Ethyl-N-(2hydroxy-3-sulfopropyl)-m-toluidine (TOOS). The absorption change at 550 nm is proportional to the triglycerides concentration in the sample.
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807.92 (a)(5): Intended Use -
- CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders.
- HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
807.92 (a)(6): Technological Similarities and Differences to the Predicates
See Comparison with Predicate(s), pg. 6.
807.92 (b)(1,2): Brief Description of Nonclinical Data - Clinical Studies data does not apply
Medicon Hellas (Medicon) has performed a series of studies to confirm the substantial equivalence of their test systems against the legally marketed predicate devices mentioned above, by demonstrating the candidate devices performance against the following current laboratory methods.
Several candidate-reagent lots were used for the studies. These covered early life, mid-life reagents when available (but always included three lots) as well as "end of on-board life". Studies confirmed equivalent performance of the candidate systems during their noted life cycle stages in order to support total shelf-life assignment.
Studies included accuracy (method comparison), reportable range (linearity), precision (reproducibility, between run and within lab [total]) and interfering substances. The following tables provide summary results.
Accuracy (Method Comparisons) - A minimum of 75 left-over specimens, spanning the dynamic ranges, were assayed in singleton and in a blinded fashion on the candidate and predicate systems. Results were tabulated and evaluated using Analyse-it statistics calculator software to generate Passing-Bablok regression statistics. Accuracy statistics are reported as Passing-Bablok regression statistics.
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Substantial Equivalence Information:
A. Predicate Device Name(s):
OLYMPUS CHOLESTEROL REAGENT (K925603) DIRECT HDL (K981224) DIRECT LDL (K981303) OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804)
B. Predicate 510(k) Numbers:
K925603, K981224, K981303, and K063804
C. Comparison with Predicate(s):
Device Comparison Table: CHOLESTEROL
| Reagent | CHOLESTEROL | OLYMPUS
CHOLESTEROL
REAGENT (K925603) |
|---------------------------------------------------------------------|----------------------------------------------|---------------------------------------------|
| Classification | 21 CFR § 862.1175, CHH | Same |
| Method comparison (correlation to comparator) | 0.9980 | 1.000 |
| Reportable range | 20 to 700 mg/dL | 20 to 700 mg/dL |
| Sensitivity LoD / LoQ | LoD 4.4 / LoQ 4.6 (mg/dL) | LoD 1mg/dL / Not defined |
| Precision (within run & total for all LVs) | 4 National Cholesterol Education Program. Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 01-3670 May 2001