(344 days)
Not Found
No
The device description details enzymatic and photometric methods for measurement and calculations based on measured values. There is no mention of AI or ML.
No
The device is for in vitro diagnostic use, meaning it's used to diagnose conditions by analyzing samples outside the body. It quantifies cholesterol, triglycerides, and glucose, which are measurements used in the diagnosis and treatment of various disorders, but it does not treat or prevent disease directly.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "for in vitro diagnostic use only" and lists various measurements (cholesterol, HDL, triglycerides, glucose) that are "used in the diagnosis and treatment of disorders."
No
The device description clearly outlines a system comprised of both a portable analyzer (hardware) and test cassettes (hardware/consumable), in addition to the underlying enzymatic and photometric methodologies. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Cholestech LDX™ System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only".
- Nature of Testing: The device performs quantitative determination of various analytes (total cholesterol, HDL cholesterol, triglycerides, and glucose) in biological samples (whole blood). This is a core function of in vitro diagnostics.
- Clinical Use: The intended uses of the measurements (diagnosis and treatment of various disorders involving lipid metabolism and carbohydrate metabolism) are clinical applications that rely on in vitro diagnostic testing.
- Device Description: The description details the enzymatic and solid-phase methodologies used to analyze the blood sample, which are typical techniques employed in in vitro diagnostic devices.
- Intended User: The "Intended User / Care Setting" section specifies "For professional in vitro diagnostic use only".
All these points clearly indicate that the Cholestech LDX™ System is designed and intended for use as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cholestech LDX™ System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes:
The Lipid Profile•GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.
The TC • HDL • GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood.
The TC •GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood.
The Lipid Profile cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.
The TC • HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood.
The TC cassette is for the quantitative determination of total cholesterol in whole blood.
- . Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
- . HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglyceride 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.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate ● metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Product codes (comma separated list FDA assigned to the subject device)
CGA, CHH, JGY, JJE, LBS
Device Description
The Cholestech LDX ™ system combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to the Cholestech LDX™ cassette.
The cassette is then placed into the Cholestech LDX™ Analyzer where a unique system on the cassette separates the plasma from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low- and very low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate (50,000 MW) and magnesium acetate precipitating reagent.The filtrate, containing both glucose and HDL cholesterol, is transferred to both the glucose and HDL cholesterol reaction pads.
The Cholestech LDX ™ Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al, and Roeschlau. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-
Aminoantipyrine and N-ethyl-N-sulfohydroxypropyl-m-toluidine, sodium sale (TOOS) to form a purple-colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample.
The analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol. Estimated LDL cholesterol and non-HDL cholesterol and a TC/HDL ratio are calculated using the measured values for TC, HDL, and Triglycerides.
The analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as that for total cholesterol, HDL cholesterol and triglycerides. The resultant color in all the reactions is measured by reflectance photometry.
A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX ™ Analyzer to convert the reflectance reading (% R) to the total cholesterol, HDL cholesterol, triglycerides and glucose concentrations.
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
The System is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years.
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)
Verification studies were performed as required by risk analysis and all acceptance criteria were met.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 20, 2023
Alere San Diego, Inc. Nathifa Bradshaw Manager, Regulatory Affairs 9942 Mesa Rim Road San Diego, California 92121
Re: K223179
Trade/Device Name: Cholestech LDX TM System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CHH, LBS, JGY, JJE Dated: June 6, 2023 Received: June 6, 2023
Dear Nathifa Bradshaw:
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. 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 located 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.
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
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. Acting 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
Enclosure
2
Indications for Use
510(k) Number (if known) K223179
Device Name Cholestech LDX™ System
Indications for Use (Describe)
The Cholestech LDX™ System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes:
The Lipid Profile GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density Ilpoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.
The TC+HDL GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood.
The TC GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood.
The Lipid Profile cassette is for the quantitative determination of total cholesterol. HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.
The TC+HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood.
The TC cassette is for the quantitative determination of total cholesterol in whole blood.
· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
· Triglyceride measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
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
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Image /page/4/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter "A" in blue, positioned above the company name "Abbott" in black. The "A" is designed with rounded edges and a gap in the middle, giving it a modern and abstract appearance. The overall design is clean and professional, reflecting the company's focus on health and innovation.
510(K) SUMMARY 5
The following 510(k) Summary was prepared in accordance with 21 CFR 807.92
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Image /page/5/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized letter 'a' in blue, positioned above the company name 'Abbott' in black, sans-serif font. The 'a' symbol is a rounded, geometric shape with a gap in the upper right corner, giving it a modern and distinctive look. The overall design is clean and professional, reflecting the company's focus on health and innovation.
General Information 5.1
| Document #: | K223179 & CW220017 |
|---|---|
| Type of 510(k): | Dual Submission- 510(k) and CLIA Waiver |
| Applicant Name: | Alere San Diego, Inc. |
| 9942 Mesa Rim Rd | |
| San Diego, California 92121 | |
| United States | |
| Establishment Registration: | #2027969 |
| Company Contact: | Nathifa Bradshaw |
| Regulatory Affairs Manager | |
| Phone: +1-561-428-2203 | |
| Email: nathifa.bradshaw@abbott.com | |
| Date Prepared: | September 19, 2023 |
5.2 Device Identification
| Device Common Name | Glucose and Cholesterol (total) test system |
|---|---|
| Device Trade Name | Cholestech LDX™ System |
Classification:
| Product Code | Classification | Regulation Section | Classification Panel |
|---|---|---|---|
| CGA | Class II | 21 CFR 862.1345 | Clinical Chemistry |
| CHH | Class I | 21 CFR 862.1175 | Clinical Chemistry |
| JGY | Class I | 21 CFR 862.1705 | Clinical Chemistry |
| JJE | Class I | 21 CFR 862.2160 | Clinical Chemistry |
| LBS | Class I | 21 CFR 862.1475 | Clinical Chemistry |
Predicate Device:
Cholestech LDX™ System (K120615)
The following are the legally marketed devices covered under the predicate device clearance, K120615, and their prior clearances:
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Image /page/6/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized, lowercase "a" in a light blue color. Below the symbol is the word "Abbott" in a bold, black font. The logo is simple and modern, conveying a sense of professionalism and innovation.
The original Cholestech LDX™ lipid monitoring system was cleared under premarket notification K901900 for use with Cholestech LDX ™ analyzer.
In addition to total cholesterol, the analytes glucose, HDL, triglycerides were cleared under premarket notification K932727.
The Cholestech multianalyte controls and calibration verification materials were originally cleared under premarket notification K102700.
Cholestech LDX™ software update to incorporate a humidity sensor was cleared under premarket notification K120615.
5.3 Device Description
The Cholestech LDX ™ system combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to the Cholestech LDX™ cassette®.
The cassette is then placed into the Cholestech LDX™ Analyzer where a unique system on the cassette separates the plasma from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low- and very low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate (50,000 MW) and magnesium acetate precipitating reagent.The filtrate, containing both glucose and HDL cholesterol, is transferred to both the glucose and HDL cholesterol reaction pads.
The Cholestech LDX ™ Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al, and Roeschlau. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-
a In this submission Cholestech LDX™ cassette refers to all six available configurations as indicated in the Package Insert. Section 5: 510(k) Summary
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Image /page/7/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized, rounded letter 'a' in blue, positioned above the company name, "Abbott," which is written in a bold, sans-serif font. The overall design is clean and modern, reflecting a corporate identity.
Aminoantipyrine and N-ethyl-N-sulfohydroxypropyl-m-toluidine, sodium sale (TOOS) to form a purple-colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample.
Image /page/7/Figure/3 description: This image shows three chemical reactions. The first reaction shows Cholesterol esters and H2O reacting with Cholesterol esterase to produce Free cholesterol and Fatty acids. The second reaction shows Cholesterol and O2 reacting with Cholesterol oxidase to produce Cholest-4-ene-3-one and H2O2. The third reaction shows 2 H2O2, 4-Aminoantipyrine, and TOOS reacting with Peroxidase to produce Quinoneimine dye and 4 H2O.
The analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol. Estimated LDL cholesterol and non-HDL cholesterol and a TC/HDL ratio are calculated using the measured values for TC, HDL, and Triglycerides.
Image /page/7/Figure/5 description: This image shows a series of chemical reactions. In the first reaction, triglycerides and H2O react in the presence of Lipase to produce Glycerol and Free fatty acids. In the second reaction, Glycerol and ATP react in the presence of Glycerol kinase and Mg2+ to produce Glycerol-3-phosphate and ADP. In the third reaction, Glycerol-3-phosphate and O2 react in the presence of Glycerol phosphate Oxidase to produce Dihydroxyacetone phosphate and H2O2. In the fourth reaction, 2 H2O2, 4-Aminoantipyrine, and TOOS react in the presence of Peroxidase to produce Quinoneimine dye and 4 H2O.
The analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as that for total cholesterol, HDL cholesterol and triglycerides. The resultant color in all the reactions is measured by reflectance photometry.
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Image /page/8/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter 'a' in a light blue color, positioned above the word "Abbott" in bold, black font. The 'a' symbol is a rounded, geometric shape, and the overall design is clean and modern.
Cholestech LDX™ System Dual Submission- 510(k) and CLIA Waiver K223179 & CW22017
| Glucose + O₂ | Glucose oxidase o-D-gluconolactone + H₂O₂ |
|---|---|
| 2 H₂O₂ + 4-Aminoantipyrine + TOOS | Peroxidase Quinoneimine dye + 4 H₂O |
A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX ™ Analyzer to convert the reflectance reading (% R) to the total cholesterol, HDL cholesterol, triglycerides and glucose concentrations.
5.4 Intended Use/Indications for Use
The Cholestech LDX ™ System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes:
The Lipid Profile•GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.
The TC • HDL • GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood.
The TC •GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood.
The Lipid Profile cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.
The TC • HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood.
The TC cassette is for the quantitative determination of total cholesterol in whole blood.
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Image /page/9/Picture/0 description: The image shows the logo for Abbott. The logo consists of a stylized letter 'A' in blue, positioned above the word "Abbott" in black, bold font. The 'A' symbol is a rounded, geometric shape, and the overall design is clean and modern.
- . Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
- . HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglyceride 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.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate ● metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
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Image /page/10/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter "a" in a light blue color, positioned above the company name "Abbott" in bold, black font. The "a" symbol is a rounded, geometric shape, and the overall design is clean and modern.
| Attribute | Predicate Device – K120615 | Candidate Device-K223179 | |
|---|---|---|---|
| Cholestech LDX™ analyzer and | |||
| Cholestech Lipid Profile•GLU Cassette | Modified Cholestech LDX™ System | ||
| Similarities | |||
| Assay | |||
| principle | The Cholestech LDX ™ System combines | ||
| enzymatic methodology5 and solid-phase | |||
| technology to measure total cholesterol, HDL | |||
| cholesterol, triglycerides and glucose. | |||
| Samples used for testing can be whole blood | |||
| from a fingerstick (collected in a lithium | |||
| heparin-coated capillary tube) or | |||
| venipuncture. The sample is applied to an | |||
| Cholestech LDX ™ cassette. | Same | ||
| Sample Type | Whole blood | Same | |
| Analyzer | Cholestech LDX™ analyzer | Same | |
| User Interface | User display and operating instructions in | ||
| labeling | Same | ||
| Attribute | Predicate Device - K120615 | ||
| Cholestech LDX™ analyzer and | |||
| Cholestech Lipid Profile•GLU Cassette | Candidate Device-K223179 | ||
| Modified Cholestech LDX™ System | |||
| Warning and | |||
| Precautions | For professional in vitro diagnostic use only. | ||
| All blood samples, containers, capillary tubes | |||
| and materials that have come in contact with | |||
| blood should be handled as if capable of | |||
| transmitting infectious disease and discarded | |||
| into a biohazardous waste container after use. | Same | ||
| Differences | |||
| Intended Use | The Alere Cholestech LDX™ System is a | ||
| small, portable analyzer and test cassette | |||
| system. The System is for in vitro | |||
| diagnostic use only. The Lipid | |||
| Profile•GLU Cassette is for the | |||
| quantitative determination of total | |||
| cholesterol, HDL (high-density | |||
| lipoprotein) cholesterol, triglycerides and | |||
| glucose in whole blood. A TC/HDL (total | |||
| cholesterol/HDL cholesterol) ratio and | |||
| estimated values for LDL (low-density | |||
| lipoprotein) and non-HDL cholesterol are | |||
| calculated by the Alere Cholestech LDX™ | |||
| Analyzer. | The CholestechLDX™ System is a small, | ||
| portable analyzer and test cassette system. | |||
| The system is for In Vitro diagnostic use | |||
| only. The Lipid Profile•GLU Cassette is for | |||
| the quantitative determination of total | |||
| cholesterol, HDL (high-density lipoprotein) | |||
| cholesterol, triglycerides and glucose in | |||
| whole blood. A TC/HDL (total | |||
| cholesterol/HDL cholesterol) ratio and | |||
| estimated values for LDL (low-density | |||
| lipoprotein) and non-HDL cholesterol are | |||
| calculated by the Cholestech LDX™ | |||
| analyzer. Cholestech LDX™ system should | |||
| not be used for testing in children under the | |||
| age of 2 years. The Cholestech LDX™ | |||
| Attribute | Predicate Device - K120615 | ||
| Cholestech LDX™ analyzer and | |||
| Cholestech Lipid Profile•GLU Cassette | Candidate Device-K223179 | ||
| Modified Cholestech LDX™ System | |||
| • Cholesterol measurements are used in | |||
| the diagnosis and treatment of disorders | |||
| involving excess cholesterol in the blood | |||
| and lipid and lipoprotein metabolism | |||
| disorders. | |||
| • HDL (lipoprotein) measurements are | |||
| used in the diagnosis and treatment of | |||
| lipid disorders (such as diabetes | |||
| mellitus), atherosclerosis, and various | |||
| liver and renal diseases. | |||
| • Triglyceride 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. | |||
| • Glucose measurements are used in the | |||
| diagnosis and treatment of carbohydrate | |||
| metabolism disorders including diabetes | |||
| mellitus, neonatal hypoglycemia, and | |||
| idiopathic hypoglycemia, and of | |||
| pancreatic islet cell carcinoma. | System is comprised of the Cholestech LDX | ||
| Analyzer and the following cassettes: | |||
| The Lipid Profile•GLU cassette is for the | |||
| quantitative determination of total | |||
| cholesterol, HDL (high-density lipoprotein) | |||
| cholesterol, triglycerides and glucose in | |||
| whole blood. The TC/HDL (total | |||
| cholesterol/HDL cholesterol) ratio and | |||
| estimated values for LDL (low-density | |||
| lipoprotein) and non-HDL cholesterol are | |||
| also reported. | |||
| The TC•HDL•GLU cassette is for the | |||
| quantitative determination of total | |||
| cholesterol, HDL (high-density lipoprotein) | |||
| cholesterol, and glucose in whole blood. | |||
| The TC•GLU cassette is for the quantitative | |||
| determination of total cholesterol and | |||
| glucose in whole blood. | |||
| The Lipid Profile cassette is for the | |||
| quantitative determination of total | |||
| cholesterol, HDL (high-density lipoprotein) | |||
| cholesterol, and triglycerides in whole | |||
| blood. The TC/HDL (total cholesterol/HDL | |||
| cholesterol) ratio and estimated values for | |||
| LDL (low-density lipoprotein) and non-HDL | |||
| cholesterol are also reported. | |||
| The TC•HDL cassette is for the quantitative | |||
| determination of total cholesterol and HDL | |||
| Attribute | Predicate Device – K120615 | ||
| Cholestech LDX™ analyzer and | |||
| Cholestech Lipid Profile•GLU Cassette | Candidate Device-K223179 | ||
| Modified Cholestech LDX™ System | |||
| (high-density lipoprotein) cholesterol in | |||
| whole blood. |
The TC cassette is for the quantitative
determination of total cholesterol in whole
blood.
Cholesterol measurements are used
in the diagnosis and treatment of
disorders involving excess
cholesterol in the blood and lipid an
lipoprotein metabolism disorders. HDL (lipoprotein) measurements are
used in the diagnosis and treatment
of lipid disorders (such as diabetes
mellitus), atherosclerosis, and
various liver and renal diseases. Triglyceride 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. Glucose measurements are used in
the diagnosis and treatment of
carbohydrate metabolism disorders
including diabetes mellitus,
idiopathic hypoglycemia, and of
pancreatic islet cell carcinoma. | |
| Limitations | Some substances may cause inaccurate
results with enzymatic tests. The
substances listed below were tested for
interference with all analytes. Less than | Some substances may cause inaccurate
results with enzymatic tests. The substances
listed below were tested for interference | |
| Attribute | Predicate Device – K120615
Cholestech LDX™ analyzer and
Cholestech Lipid Profile•GLU Cassette | Candidate Device-K223179
Modified Cholestech LDX™ System | |
| | 10% interference was seen at the levels shown. | with all analytes. Less than 10% interference was seen at the levels shown. | |
| | Substance Concentration (mg/dL) | Substance Concentration (mg/dL) | |
| | Ascorbic Acid 1 | Ascorbic Acid 1 Glutathione 1 | |
| | Hemoglobin 125 | Conjugated Bilirubin 2.5 Hemoglobin 1 | |
| | Bilirubin 5 | Unconjugated Bilirubin 2.5 Lactose 1 | |
| | Lactose 100 | Creatinine 30 Lovastatin (Mevacor) 4 | |
| | Creatinine 30 | Cysteine 10 Nicotinic Acid (Niacin) 10 | |
| | Lovastatin (Mevacor) 4 | Fructose 30 Urea 500 | |
| | Cysteine 10 | Gemfibrozil (Lopid) 15 Uric Acid 15 | |
| | Nicotinic Acid (Niacin) 10 | | |
| | Fructose 30 | | |
| | Urea 500 | | |
| | Gemfibrozil (Lopid)15 | | |
| | Uric Acid 15 | | |
| | Glutathione 1 | | |
| | • Hematocrits between 30% and 49% do not affect results. | • Hematocrits between 30% and 49% do not affect results. | |
| | • Blood collection tubes with glycerol should not be used for the triglyceride test. | • Blood collection tubes with glycerol should not be used for the triglyceride test. | |
| | • Hand creams and soaps with glycerol may cause falsely high triglyceride results. | • Hand creams and soaps with glycerol may cause falsely high triglyceride results. | |
| | | • The triglyceride test measures triglycerides and free glycerol. Free glycerol usually is less than 20 mg/dL. | |
| | | • There may be a 6–7% difference in the glucose levels of fingerstick and venous blood. | |
| Attribute | Predicate Device – K120615
Cholestech LDX™ analyzer and
Cholestech Lipid Profile•GLU Cassette | Candidate Device-K223179
Modified Cholestech LDX™ System | |
| | The triglyceride test measures triglycerides and free glycerol.
Free glycerol usually isless than 20 mg/dL. There may be a 6–7% difference in the glucose levels of fingerstick and venous blood. | | |
5.5 Comparison with Predicate
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Image /page/11/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized letter 'a' in blue, positioned above the company name "Abbott" in bold, black font. The 'a' symbol is a rounded, geometric shape, and the overall design is clean and modern.
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Image /page/12/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized, rounded "a" in a light blue color. Below the symbol is the word "Abbott" in a bold, black font. The logo is simple and modern, reflecting the company's focus on innovation and health.
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Image /page/13/Picture/0 description: The image shows the logo for Abbott. The logo consists of a stylized letter 'a' in blue, positioned above the word "Abbott" in black, sans-serif font. The 'a' is designed with rounded corners and a continuous line, giving it a modern and clean appearance. The overall design is simple, recognizable, and corporate.
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Image /page/14/Picture/0 description: The image contains the logo for Abbott Laboratories. The logo features a stylized, sans-serif letter 'a' in blue, positioned above the company name, "Abbott," which is written in a bold, sans-serif font. The overall design is clean and modern, reflecting the company's focus on innovation and healthcare.
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Image /page/15/Picture/0 description: The image contains the logo for Abbott Laboratories. The logo features a stylized, sans-serif letter 'a' in a bright blue color. Below the symbol, the word "Abbott" is written in a bold, black, sans-serif font. The logo is simple and modern, conveying a sense of professionalism and trustworthiness.
5.6 Technological Characteristics
Cholestech LDX ™ system maintains the same intended use and indications for use. The principle of operations, and chemical composition remains unchanged.
5.7 Description of Device Modification
The modification to the labeling of the Cholestech LDX™ system is to update the performance claim of the device as it pertains to interference level of conjugated and unconjugated Bilirubin. The population of the intended use of the device has been further specified to indicate that the system should not be used for testing in children under the age of 2 years; and for Glucose measurements, to remove use in neonatal hypoglycemia.
5.8 Design Control Activities
The verification studies of the device modification have been performed under design control. The design control activities were based on risk analysis, and acceptance criteria were set to maintain the performance and safety of the Cholestech LDX ™ system. The risk analysis identified the appropriate in-house analytical performance verification studies to demonstrate that the analytical performance and risk of erroneous results for Cholestech LDX ™ system are not adversely affected by using the proposed modification device.
5.9 Conclusion
Verification studies were performed as required by risk analysis and all acceptance criteria were met. The technological characteristics of the predicate device cleared under K120615 are the same as the modified device, and the system maintains the same Section 5: 510(k) Summary Page 12 of 13
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Image /page/16/Picture/0 description: The image contains the logo for Abbott Laboratories. The logo features a stylized, rounded letter 'a' in blue, positioned above the company name, "Abbott," which is written in a bold, black font. The logo is simple and modern, conveying a sense of stability and innovation.
intended use and indications for use as the predicate device. In addition, the update to the Bilirubin Interference claim and further specification of the population in the indications for use/intended use did not raise new or different questions of safety and effectiveness; therefore, the Cholestech LDX™ system is found to be substantially equivalent to the predicate device.