Who is the manufacturer of Cholesterol?

Randox Laboratories, Ltd. filed the 510(k) submission for Cholesterol (K150654).

What is the FDA product code for Cholesterol?

CHH. It is classified under 21 CFR 862.1175 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for Cholesterol?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Cholesterol?

Randox Laboratories Ltd, Cholesterol reagent (K923504).

Who can help prepare an FDA 510(k) submission like Cholesterol?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cholesterol

K150654 · Randox Laboratories, Ltd. · CHH · Sep 29, 2015 · Clinical Chemistry

Device Facts

Record ID	K150654
Device Name	Cholesterol
Applicant	Randox Laboratories, Ltd.
Product Code	CHH · Clinical Chemistry
Decision Date	Sep 29, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1175
Device Class	Class 1

Intended Use

For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Device Story

Randox Cholesterol test system is a quantitative colorimetric assay for serum and plasma; utilizes RX Daytona Plus analyzer. Reagent (R1) contains cholesterol esterase, cholesterol oxidase, peroxidase, 4-aminoantipyrine, and phenol. Cholesterol esters hydrolyzed to free cholesterol; oxidized by cholesterol oxidase to produce hydrogen peroxide; reacts with phenol and 4-aminoantipyrine via peroxidase to form red quinoneimine complex. Absorbance measured at 510 nm/700 nm; intensity proportional to cholesterol concentration. Used in clinical laboratory settings by trained personnel. Output provides cholesterol concentration (mg/dL) to assist clinicians in diagnosing and treating lipid/lipoprotein metabolism disorders and atherosclerosis. Benefits include standardized monitoring of blood cholesterol levels.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (CVs < 3%). Linearity per CLSI EP6-A (range 25-618 mg/dl). LoD 6.31 mg/dl; LoQ 23.2 mg/dl. Analytical specificity confirmed for hemoglobin, bilirubin, Intralipid, and ascorbic acid. Method comparison against predicate (n=107) yielded y=1.00x-4.77 (r=0.997). Matrix comparison for Li-Heparin (n=54) and K2-EDTA (n=50) plasma showed high correlation (r≥0.997) to serum.

Technological Characteristics

Quantitative colorimetric enzymatic assay. Reagents: 4-aminoantipyrine, phenol, peroxidase, cholesterol esterase, cholesterol oxidase, sodium azide. Measurement: absorbance at 510/700 nm. Form factor: liquid ready-to-use reagent. Connectivity: integrated with RX Daytona Plus analyzer. Standards: CLSI EP5-A2, EP17-A2, EP9-A2, EP6-A.

Indications for Use

Indicated for the quantitative in vitro determination of cholesterol in serum and plasma for the diagnosis and treatment of disorders involving excess blood cholesterol and lipid/lipoprotein metabolism disorders.

Regulatory Classification

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.

Predicate Devices

Randox Laboratories Ltd, Cholesterol reagent (K923504)

Reference Devices

Randox Assayed Multisera Level 2 (K942458)
Randox Assayed Multisera Level 3 (K942458)
Randox Calibration Serum Level 3 (K053153)

Related Devices

K992803 — SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP · Sigma Diagnostics, Inc. · Sep 13, 1999
K982469 — HICHEM CHOLESTEROL REAGENT KIT · Elan Pharma, Inc. · Aug 19, 1998
K153435 — Direct HDL Cholesterol (HDL) · Randox Laboratories, Ltd. · Jan 8, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND ROAD CRUMLIN BT29 4QY GREAT BRITAN September 29, 2015 Re: K150654 Trade/Device Name: Cholesterol Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets the limitation of exemption 21 CFR §862.9(c)(4) Product Code: CHH Dated: September 21, 2015 Received: September 24, 2015 Dear Dr. Armstrong: 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Katherine Serrano -S For: Courtney H. Lias Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K150654 Device Name Cholesterol Indications for Use (Describe) For the quantitative in vitro deternination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism 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. 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(K) SUMMARY, CHOLESTEROL REAGENT # 1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92. #### SUBMITTER NAME AND ADDRESS 2. Name: Dr Pauline Armstrong Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom. Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com Date of Summary Preparation: September 29, 2015 # 3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER 510k No: K150654 Device Proprietary Name: Cholesterol Common Name: Cholesterol # Purpose for Submission: New Device | Product Code | Regulation Name | Classification | Regulation Section | Panel | |-----------------|------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------|-------------------------------| | CHH | Cholesterol (Total) test system | Class I, meets the limitation of exemption 21 CFR §862.9(c)(4) | 21 CFR §862.1175 Cholesterol (total) Test System | Clinical Chemistry (75) | {4}------------------------------------------------ # 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS ### Predicate Device Proprietary Name: Randox Laboratories Ltd, Cholesterol reagent 510 (k) Number: K923504 # 5. INTENDED USE For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. ## 6. DEVICE DESCRIPTION The Cholesterol kit assay consists of ready to use reagent solutions. ### CATALOGUE NUMBER: CH8310 R1. Reagent 4 x 20 ml ### REAGENT COMPOSITION | Contents | Concentrations in the Test | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | R1. Reagent 4-Aminoantipyrine Phenol Peroxidase (E.C.1.11.1.7, Horse Radish, +25°C) Cholesterol esterase (E.C.3.1.1.13. Pseudomonas, +37°C) Cholesterol oxidase (E.C.1.1.3.6. Nocardia, +37°C) Sodium Azide | 0.25 mmol/l 6.00 mmol/l ≥0.50 U/ml ≥ 0.20 U/ml ≥0.10 U/ml 0.09% | ### MATERIALS REQUIRED BUT NOT PROVIDED Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # k942458 Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # k053153 RX series Saline (Cat. No. SA 8396) {5}------------------------------------------------ # 7. PREDICATE DEVICE COMPARISON TABLE ### Table 1 Comparison of Cholesterol test system for the RX Daytona plus to predicate device | CHARACTERISTICS | Cholesterol Assay for RX daytona plus (New Device) | Randox Cholesterol (K923504) (Predicate Device) | | | | | | | | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--|--|--|--|--|--|--| | Similarities | | | | | | | | | | | INTENDED USE | For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders | Same | | | | | | | | | ASSAY PROTOCOL | Enzymatic Endpoint Method | Same | | | | | | | | | STORAGE (UNOPENED) | Reagents are stable up to the expiry date when stored unopened at +2 to +8°C | Same | | | | | | | | | SAMPLE TYPE | Serum Plasma (Li Heparin & K2 EDTA) | Same | | | | | | | | | CONTROL FREQUENCY | Randox assayed human multisera Level 2 & 3 Two levels of control should be assayed at least once a day | Same | | | | | | | | | CALIBRATION FREQUENCY | Every 28 days, with a change of reagent lot or as indicated by quality control procedures. | Same | | | | | | | | | Differences | | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | REAGENT COMPOSITION | R1. Reagent 4-Aminoantipyrine 0.25 mmol/l Phenol 6.00 mmol/l Peroxidase ≥0.50 U/ml (E.C.1.11.1.7, Horse Radish, +25°C) Cholesterol esterase ≥ 0.20 U/ml (E.C.3.1.1.13. Pseudomonas, +37°C) Cholesterol oxidase ≥ 0.10 U/ml (E.C.1.1.3.6. Nocardia, +37°C) Sodium Azide 0.09% | R1. Reagent Pipes Buffer 80 mmol/l, pH 6.8 4-Aminoantipyrine 0.25 mmol/l Phenol 6 mmol/l Peroxidase ≥0.5 U/ml (E.C.1.11.1.7, Horse Radish, +25°C) Cholesterol esterase ≥0.15 U/ml (E.C.3.1.1.13. Pseudomonas, 37°C) Cholesterol oxidase ≥0.10 U/ml (E.C.1.1.3.6. Nocardia, 37°C) | | MEASURING RANGE | 25 to 618 mg/dl | 0.55 to 750 mg/dl | {6}------------------------------------------------ # 8. TEST PRINCIPLE (1) The cholesterol is determined after enzymatic hydrolysis and oxidation. The indicator quinoneimine is formed from hydrogen peroxide and 4-aminoantipyrine in the presence of phenol and peroxidase. Image /page/6/Figure/2 description: This image shows three chemical reactions. The first reaction shows cholesterol ester and H20 reacting to form cholesterol and fatty acids, with cholesterol-esterase as the catalyst. The second reaction shows cholesterol and O2 reacting to form cholestene-3-one and H202, with cholesterol oxidase as the catalyst. The third reaction shows 2H202, phenol, and 4-Aminoantipyrine reacting to form quinoneimine and 4H20, with peroxidase as the catalyst. 1. Abell, L.L, Levey, B.B., Brodie B.B., et al, J. Biol Chem 195 : 357, 1952 # 9. PERFORMANCE CHARACTERISTICS # Analytical performance: # a. Precision/Reproducibility: Precision was evaluated consistent with C.L.S.I documents EP5-A2 Precision studies were performed by two operators on two RX Daytona plus systems using control material and unaltered human serum samples that were spiked with Cholesterol concentrations or diluted to achieve concentrations based on established ranges <200mg/dl desirable cholesterol level ; 200 - 239 mg/dl borderline high cholesterol level and ≥240 mg/dl high cholesterol levels . Testing was conducted for two reagent lots of Cholesterol, one lot on each RX Daytona plus system, twice per day for 20 non-consecutive days. Two replicates per run were performed for each sample. No assay re-calibrations were required throughout the duration of the study. The results are summarized in the following tables. | System: RX Daytona Plus | | | Within Run | | Among Run | | Among Day | | Total | | |-------------------------|---------|-----------------|------------|-----------|-----------|-----------|-----------|-----------|-------|-----------| | Method Lot 1 | Product | MEAN (mg/dl) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | | Cholesterol | 717UE | 283 | 5.56 | 2.0 | 0.00 | 0.0 | 0.82 | 0.3 | 5.62 | 2.0 | | Cholesterol | 724UE | 307 | 5.02 | 1.6 | 0.98 | 0.3 | 2.44 | 0.8 | 5.66 | 1.8 | | Cholesterol | 952UN | 190 | 3.33 | 1.8 | 1.33 | 0.7 | 1.02 | 0.5 | 3.73 | 2.0 | # Table 2 Precision Summary {7}------------------------------------------------ | System: RX Daytona Plus | | Within Run | | Among Run | | Among Day | | Total | | | |-------------------------|----------------------------------------------------|-----------------|------|-----------|------|-----------|------|-----------|-------|-----------| | Method Lot 1 | Product | MEAN (mg/dl) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | | Cholesterol | Level 1 (Diluted Patient Sample | 176 | 3.30 | 1.9 | 2.42 | 1.4 | 1.55 | 0.9 | 4.37 | 2.5 | | Cholesterol | Level 2 (Diluted Patient Sample | 226 | 3.95 | 1.7 | 2.79 | 1.2 | 2.22 | 1.0 | 5.32 | 2.4 | | Cholesterol | Level 3 (Diluted Patient Sample | 270 | 3.95 | 1.5 | 4.09 | 1.5 | 0.00 | 0.0 | 5.69 | 2.1 | | Cholesterol | Linearity Pool (Spiked Patient Sample) | 586 | 0.03 | 1.2 | 9.30 | 1.6 | 0.00 | 0.0 | 11.63 | 2.0 | | Cholesterol | Sensitivity Pool | 33.2 | 0.28 | 3.5 | 2.45 | 7.4 | 1.09 | 3.3 | 2.93 | 8.8 | | System: RX Daytona Plus | | Within Run | | Among Run | | Among Day | | Total | | | |-------------------------|----------------------------------------------------|-----------------|------|-----------|------|-----------|------|-----------|------|-----------| | Method Lot 2 | Product | MEAN (mg/dl) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | | Cholesterol | 717UE | 285 | 4.22 | 1.5 | 2.68 | 0.9 | 2.49 | 0.9 | 5.59 | 2.0 | | Cholesterol | 724UE | 310 | 5.52 | 1.8 | 3.94 | 1.3 | 2.47 | 0.8 | 7.22 | 2.3 | | Cholesterol | 952UN | 192 | 3.33 | 1.7 | 3.29 | 1.7 | 0.00 | 0.0 | 4.68 | 2.4 | | Cholesterol | Level 1 (Diluted Patient Sample | 177 | 3.56 | 2.0 | 1.57 | 0.9 | 2.83 | 1.6 | 4.82 | 2.7 | | Cholesterol | Level 2 (Diluted Patient Sample | 228 | 4.04 | 1.8 | 4.70 | 2.1 | 0.00 | 0.0 | 6.20 | 2.7 | | Cholesterol | Level 3 (Diluted Patient Sample | 272 | 3.84 | 1.4 | 6.27 | 2.3 | 0.00 | 0.0 | 7.35 | 2.7 | | Cholesterol | Linearity Pool (Spiked Patient Sample) | 592 | 6.76 | 1.1 | 9.11 | 1.5 | 0.00 | 0.0 | 11.3 | 1.9 | | Cholesterol | Sensitivity Pool | 32.4 | 1.17 | 3.6 | 3.14 | 9.7 | 0.00 | 0.0 | 3.35 | 10.3 | {8}------------------------------------------------ b. Linearity/assay reportable range: Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration (or where deviation from linearity is less than 5%). The linearity samples were prepared at 11 levels covering the measuring range. Each level was run in replicates of five on two lots of cholesterol reagent on one RX Daytona plus system. The results are summarized in the following table: Table 3 Linearity Summary including Regression equation and correlation co-efficient. Image /page/8/Figure/4 description: The image is a graph titled "Linearity". The x-axis is labeled "Level" and ranges from 0 to 12. The y-axis is labeled "Mean Result" and ranges from 0 to 700. The graph contains a scatter plot of mean values, a solid line representing a linear fit to levels 1-5, and a dashed line representing a linear fit to levels 2-6. | Slope | 0.99 | |-----------|-------| | Intercept | -3.71 | | r | 0.999 | | Syx | 4.85 | # Linearity Summary | Analvte | Linearitv | Reportable Range | | | |-------------|-----------|------------------|--|--| | Cholesterol | 618 mg/dl | 25 – 618 mg/dl | | | The RX Daytona Plus analyzer has an auto-dilution feature that is automatically activated when measuring samples >618mg/dl, which are diluted and remeasured to obtain values within the measuring range. {9}------------------------------------------------ c. Traceability, Stability, Expected values (controls, calibrators, or methods): Refer to K053153 Calibrator and K942458 Control for Cholesterol. Randox Calibration Serum Level 3 is traceable to Cholesterol reference material NIST 1952a. # d. Detection limit: Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2 'Protocols for Determination of Limits of Detection and Limits of Quantification: Approved Guideline'. A Limit of Blank (L.o.B.), a Limit of Detection (L.o.D.) and a Limit of Quantification were performed on two lots of reagents tested by two operators on one RX Daytona Plus system. The Limit of Detection (LoD) for Cholesterol on the RX Daytona Plus is 6.31 mg/dl based on 240 determinations, with 4 low level samples. The Limit of Blank (LoB) is 3.1 mg/dl. The Limit of Quantitation (LoQ) is 23.2 mg/dl as determined by the lowest concentration detected with ≤20% imprecision. # e. Analytical Specificity: The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. The spiked sample results were compared to control samples prepared without the potential interferents. Acceptance Criteria: % of Control ± 10% The following analytes were tested up to the levels indicated at Cholesterol concentrations of 150 mg/dl and 250 mg/dl and found not to interfere: | Haemoglobin | No significant interference up to 750mg/dL | |---------------------|---------------------------------------------| | Total Bilirubin | No significant interference up to 60mg/dL | | Conjugate Bilirubin | No significant interference up to 60mg/dL | | Intralipid® | No significant interference up to 1000mg/dL | | Ascorbic Acid | No significant interference up to 6mg/dL | {10}------------------------------------------------ # f. Method comparison with predicate device: Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'. 107 serum patient samples spanning the range 25 to 599 mg/dl were tested by two operators on two lots of cholesterol reagent on two RX Daytona plus analyzers and one RX Imola system across 3 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained: Y = 1.00x — 4.77 Correlation coefficient of r = 0.997 ### q. Matrix comparison: Matrix method comparisons for the cholesterol assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of cholesterol reagents. Both serum and lithium heparin and K₂EDTA plasma were tested to determine whether method accuracy with plasma specimens are equivalent to serum results and that lithium heparin and K₂EDTA plasma does not interfere with either the method or the system. # Cholesterol matrix comparison on the RX Daytona plus (Lithium Heparin) Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). A minimum of 54 matched patient sample pairs were analyzed spanning the 25 to 613 mg/dl and the following linear regression equation was obtained: Y = 1.01x - 6.54 Correlation coefficient of r = 0.997 # Cholesterol matrix comparison on the RX Daytona plus (Potassium 2 EDTA) Patient samples were drawn in matched pairs – one sample serum (x) and the second sample potassium 2 EDTA plasma (y). A minimum of 50 matched patient sample pairs were analyzed spanning the 29 to 603 mg/dl and the following linear regression equation was obtained: Y = 0.99x + 2.85 Correlation coefficient of r = 0.998 {11}------------------------------------------------ # Expected values/Reference range: Referenced from literature ### Table 4 Reference Ranges | Analyte | Serum | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Cholesterol (2) | < 200 mg/dl Desirable blood cholesterol 200 – 239 mg/dl Borderline-high blood cholesterol $\ge$ 240 mmol/l High blood cholesterol | 2. Third Report of the National Cholesterol Education Programme (NCEP) Expert Panel on Detection, Evaluation and treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA Publication, Vol 285, No. 19, P2486 - 2497; 2001. # 10. CONCLUSION Testing results indicate that the proposed device is substantially equivalent to the predicate device.