(273 days)
No
The device description and performance studies focus on chemical reagents and standard analytical methods for measuring LDL-cholesterol. There is no mention of AI, ML, or image processing, which are common indicators of AI/ML use in medical devices.
No
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of LDL-cholesterol, which is for diagnosis and treatment monitoring, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is intended for prescription use only." Furthermore, it mentions that lipoprotein measurements, which this device determines, "are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases." This clearly indicates its role in diagnosis.
No
The device description explicitly states it is a "kit assay" consisting of "ready to use reagent solutions," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description mentions "ready to use reagent solutions," which are typical components of IVD kits used for laboratory testing.
- Performance Studies: The document details various performance studies (Precision, Linearity, Sensitivity, Interference, Correlation, Matrix method comparisons) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (K982529; Randox Laboratories Ltd., Direct LDL Cholesterol Reagent) is common in regulatory submissions for IVDs, where a new device is compared to an already cleared device.
- Intended User: The statement "This in vitro diagnostic device is intended for prescription use only" further confirms its classification as an IVD.
All these elements strongly indicate that this device is designed and intended for use in a laboratory setting to perform diagnostic tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. This in vitro diagnostic device is intended for prescription use only.
Product codes
MRR
Device Description
The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312
R1. Enzyme Reagent 1 4 x 20 mL
R2. Enzyme Reagent 2 4 x 9 mL
REAGENT COMPOSITION
R1. Enzyme Reagent 1
PIPES Buffer
Piperazine-1, 4-bis (2-ethanesulfonic acid)
HDAOS
N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxylaniline, sodium salt
Cholesterol Esterase
[E.C.3.1.1.13. Microorganism, 37°C]
Cholesterol Oxidase
[E.C.1.1.3.6. Streptomyces sp, 37°C]
Catalase
[E.C.1.11.1.6. Microbial]
Ascorbate Oxidase
[E.C.1.10.3.3. Acremonium sp.]
Surfactant
R2. Enzyme Reagent 2
PIPES Buffer
Piperazine-1, 4-bis (2-ethanesulfonic acid)
4-Amino antipyrine
Peroxidase
[E.C.1.11.1.7, Horse Radish, 25°C]
Surfactant
Sodium Azide
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Precision/Reproducibility:
- Study Type: Precision study consistent with C.L.S.I documents EP5-A2.
- Sample Size: 80 determinations for QC 1, 2, 3 and Serum pools 1, 2, 3, 4 each.
- Data Source: Control material and unaltered human serum samples (spiked or diluted).
- Key Results:
- QC 1 (Mean 92.0 mg/dl): Total CV 5.9%
- QC 2 (Mean 135.9 mg/dl): Total CV 4.6%
- QC 3 (Mean 186.7 mg/dl): Total CV 4.4%
- Serum pool 1 (Mean 65.0 mg/dl): Total CV 5.9%
- Serum pool 2 (Mean 154.0 mg/dl): Total CV 5.0%
- Serum pool 3 (Mean 200.1 mg/dl): Total CV 5.0%
- Serum pool 4 (Mean 343.7 mg/dl): Total CV 5.3%
Linearity/Assay Reportable Range:
- Study Type: Linearity study in accordance with C.L.S.I. standard EP6-A.
- Sample Size: 11 levels, each run in replicates of five.
- Data Source: Low and high serum pools mixed to make intermediate levels.
- Key Results:
- Linear Regression: Y = 0.99x + 6.34
- Correlation coefficient (r) = 0.997
- Reportable range: 21-740 mg/dl.
Detection Limit:
- Study Type: Sensitivity studies in accordance with C.L.S.I. guideline EP17-A2.
- Sample Size: 240 determinations (for LoD).
- Key Results:
- Limit of Blank (LoB): 1.94 mg/dl
- Limit of Detection (LoD): 3.19 mg/dl
- Limit of Quantitation (LoQ): 16.1 mg/dl (with ≤20% imprecision).
Analytical Specificity (Interference studies):
- Study Type: Interference studies in accordance with C.L.S.I. guideline EP7-A2.
- Key Results: No significant interference found for:
- Hemoglobin up to 1000 mg/dl.
- Total Bilirubin up to 60 mg/dl.
- Conjugate Bilirubin up to 60 mg/dl.
- Triglycerides up to 500 mg/dl.
- Intralipid® up to 500 mg/dl.
- Ascorbic Acid up to 6 mg/dl.
Method Comparison with Predicate Device:
- Study Type: Correlation studies in accordance with C.L.S.I. guideline EP9-A2.
- Sample Size: 139 serum patient samples.
- Data Source: Patient samples spanning 22.45 to 735.68 mg/dl.
- Key Results:
- Linear regression equation: Y = 1.01x - 1.45
- Correlation coefficient (r) = 0.998
Matrix Comparison:
- Study Type: Matrix method comparisons.
- Sample Size: 70 matched patient sample pairs (serum and lithium heparin plasma).
- Data Source: Patient samples spanning 25.45 to 665.64 mg/dl.
- Key Results:
- Linear regression equation: Y = 1.01x - 2.81
- Correlation coefficient (r) = 0.998
Key Metrics
- Precision (Total CV%): Up to 5.9%
- Linear Regression (from linearity study): Y = 0.99x + 6.34
- Correlation Coefficient (from linearity study): 0.997
- Limit of Blank (LoB): 1.94 mg/dl
- Limit of Detection (LoD): 3.19 mg/dl
- Limit of Quantitation (LoQ): 16.1 mg/dl
- Correlation Coefficient (from method comparison): 0.998
- Correlation Coefficient (from matrix comparison): 0.998
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized symbol resembling a caduceus, with three abstract human profiles facing right. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 20, 2017
RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG OA/RA MANAGER 55 DIAMOND ROAD CRUMLIN CRUMLIN, GB BT29 40Y ANTRIM UNITED KINGDOM
Re: K161691
Trade/Device Name: Direct LDL Cholesterol (LDL) Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: I, meets the limitations of exemption 21 CFR 862.9(c)(4) Product Code: MRR Dated: February 6, 2017 Received: February 9, 2017
Dear Dr. Pauline 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. Isting 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
1
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.
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/Resourcesfor You/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 vours.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161691
Device Name Direct LDL Cholesterol (LDL)
Indications for Use (Describe)
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.
This in vitro diagnostic device is intended for prescription use only.
| 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) |
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3
510(K) SUMMARY, DIRECT LDL CHOLESTEROL (LDL)
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.
2. SUBMITTER NAME AND ADDRESS
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: 16 March 2017
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K161691
Device Proprietary Name: Direct LDL Cholesterol (LDL)
Common Name: Direct LDL Cholesterol (LDL)
Purpose for Submission: New Device
| Product Code | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| MRR | Lipoprotein test system | Class I, meets the limitation of exemption 21 CFR §862.9(c)(4) | 21 CFR §862.1475 Lipoprotein Test System | Clinical Chemistry (75) |
4
4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Randox Laboratories Ltd., Direct LDL Cholesterol Reagent
510 (k) Number: K982529
5. INTENDED USE
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. This in vitro diagnostic device is intended for prescription use only.
6. DEVICE DESCRIPTION
The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312
R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL
REAGENT COMPOSITION
| Contents | Initial Concentration of Solution |
|---|---|
| R1. Enzyme Reagent 1 | |
| PIPES Buffer | |
| Piperazine-1, 4-bis (2-ethanesulfonic acid) | |
| HDAOS | |
| N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxylaniline, sodium salt | |
| Cholesterol Esterase | |
| [E.C.3.1.1.13. Microorganism, 37°C] | |
| Cholesterol Oxidase | |
| [E.C.1.1.3.6. Streptomyces sp, 37°C] | |
| Catalase | |
| [E.C.1.11.1.6. Microbial] | |
| Ascorbate Oxidase | |
| [E.C.1.10.3.3. Acremonium sp.] | |
| Surfactant | 50 mmol/l, pH 7.0 |
| 2.0 mmol/l | |
| ≥600U/I | |
| ≥500U/I | |
| ≥600KU/I | |
| ≥300U/I | |
| 0.3% (w/v) | |
| R2. Enzyme Reagent 2 | |
| PIPES Buffer | |
| Piperazine-1, 4-bis (2-ethanesulfonic acid) | |
| 4-Amino antipyrine | |
| Peroxidase | |
| [E.C.1.11.1.7, Horse Radish, 25°C] | |
| Surfactant | |
| Sodium Azide | 50 mmol/l, pH 7.0 |
| 4 mmol/l | |
| ≥4KU/I | |
| 1.00% (w/v) | |
| 0.05% (w/v) |
5
Materials required but not provided.
Direct HDL-C/LDL-C Calibrator, CH2673 (K122126). Randox Lipid Controls (K022591):-LE 2661 or LE 2668 Level 1 Level 2 LE 2662 or LE 2669 Level 3 LE 2663 or LE 2670 RX series Saline (Cat. No. SA8396)
7. PREDICATE DEVICE COMPARISON TABLE
Table 1 - Comparison of LDL Cholesterol test system for the RX Daytona Plus to
Predicate device
| Characteristics | LDL Cholesterol Assay for
RX daytona plus
(New Device) | Randox LDL cholesterol (K982529)
(Predicate Device) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| | | Similarities |
| Intended Use | For the quantitative in vitro determination
of LDL-cholesterol concentration in
human plasma and serum. | Same |
| Assay Protocol | Clearance Method | Same |
| Storage
(Unopened) | Reagents are stable up to the expiry date
when stored unopened at +2 to +8°C | Same |
| Sample Type | Serum, Heparinized Plasma are the
recommended samples. | Same |
| | | Differences |
| Measuring Range | 21 - 740 mg/dl | 7.3 to 859 mg/dl |
6
8. TEST PRINCIPLE (1, 2)
The assay consists of 2 distinct reaction steps:
-
- Elimination of chylomicron, VLDL-Cholesterol and HDL-Cholesterol by cholesterol esterase, cholesterol oxidase and subsequently catalase.
Cholesterol esterase Cholesterol ester -→Cholesterol + fatty acid Cholesterol oxidase Cholesterol + O2 → Cholestenone + H2O2 Catalase 2H2O + O2 2H2O2
- Elimination of chylomicron, VLDL-Cholesterol and HDL-Cholesterol by cholesterol esterase, cholesterol oxidase and subsequently catalase.
-
- Specific measurement of LDL-Cholesterol after release of LDL-Cholesterol by detergents in Reagent 2.
$$\text{Cholesterol ester} \xrightarrow{\text{Cholesterol esterase}} \text{Cholesterol + fatty acid}$$
$$\text{Cholesterol + O}{2} \xrightarrow{\text{Cholesterol oxidase}} \text{Cholestenone + H}{2}\text{O}_{2}$$
$$2\text{H}{2}\text{O}{2} + \text{4-AA + HDAOS} \xrightarrow{\text{Peroxidase}} \text{Quinone pigment+4H}_{2}\text{O}$$
The intensity of the quinoneimine dye produced is directly proportional to the cholesterol concentration when measured at 600 nm.
In the second reaction catalase is inhibited by sodium azide in Enzyme Reagent 2.
Key: 4 - AA - 4 - Aminoantipyrine HDAOS = N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxylaniline, sodium salt
-
- Weiland H. and Seidel D., J Lip Res, 24: 904-909, 1983.
- Friedewald W.F., et al, Clin Chem, 18: 499-502, 1972.
7
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 svstems using control material and unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges 190 mg/dL very high LDL Cholesterol. Testing was conducted for two reagent lots of Cholesterol levels, 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. The assay was calibrated on the first day of the study and no assay recalibrations were required throughout the duration of the study. The results of Lot 2, which is representative of both lots of reagent, is summarized in the following table.
| Lot 2 | | | Mean | | Within Run | | Among Run | | Among
Day | | Total |
|--------|--------------|----|---------|------|------------|------|-----------|-----|--------------|------|-------|
| Method | Product | N | (mg/dl) | SD | CV | SD | CV | SD | CV | SD | CV |
| LDL | QC 1 | 80 | 92.0 | 2.7 | 3.0 | 4.6 | 5.0 | 0.8 | 0.9 | 5.4 | 5.9 |
| LDL | QC 2 | 80 | 135.9 | 3.8 | 2.8 | 4.1 | 3.0 | 2.6 | 1.9 | 6.2 | 4.6 |
| LDL | QC 3 | 80 | 186.7 | 5.5 | 2.9 | 5.9 | 3.2 | 1.4 | 0.7 | 8.2 | 4.4 |
| LDL | Serum pool 1 | 80 | 65.0 | 1.7 | 2.6 | 3.2 | 5.0 | 1.2 | 1.8 | 3.8 | 5.9 |
| LDL | Serum pool 2 | 80 | 154.0 | 4.4 | 2.9 | 6.0 | 3.9 | 2.1 | 1.4 | 7.8 | 5.0 |
| LDL | Serum pool 3 | 80 | 200.1 | 5.8 | 2.9 | 8.2 | 4.1 | 0.0 | 0.0 | 10.0 | 5.0 |
| LDL | Serum pool 4 | 80 | 343.7 | 10.3 | 3.0 | 14.2 | 4.1 | 4.3 | 1.2 | 18.0 | 5.3 |
Table 2 Precision Summary
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 10%).
The linearity samples were prepared at 11 levels. The sponsor set a range from approximately 21 mg/dl analyte concentration up to a high concentration of approximately 850 mg/dl using low and high serum pools. The low and high pools were mixed to make nine intermediate levels. Each level was run in replicates of five on two lots of LDL Cholesterol reagent on one RX Daytona plus
8
system. The observed values were compared to the expected values; the linear regression correlation between the expected values and the observed values are summarized in the following table:
Table 3 Linearity Summary including Regression equation and correlation co-efficient.
| Analyte Tested | LDL Cholesterol
(mg/dl) |
|----------------------|----------------------------|
| Linear
Regression | $Y = 0.99x +6.34$ |
| r | 0.997 |
The reportable range of the assay is 21-740 mg/dl.
Samples with concentrations greater than the linearity limit established are returned > 740 mg/dL and are re-run automatically by the RX daytona plus using the established high re-run conditions.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Refer to K122126 Direct HDL/LDL Calibrator and K022591 Lipid Controls.
The Direct HDL-C/LDL-C Calibrator is traceable to an internal master reference material. Calibrators are value assigned using one instrument and multiple repetitions. The mean, standard deviation, and % CV are calculated and evaluated against acceptance criteria.
The reagent system has not been tested or certified by the Cholesterol Reference Method Laboratory Network (CRMLN). The labeling contains language that the device has not been certified by the CRMLN.
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 (L.o.Q) were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.
The Limit of Detection (LoD) for LDL Cholesterol on the RX Daytona Plus is 3.19 mg/dl based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 1.94 mg/dl.
9
The Limit of Quantitation (LoQ) is 16.1 mg/dl as determined by the lowest concentration detected with ≤20% imprecision.
e. Analytical Specificity:
Interference studies have been carried out in accordance with C.L.S.I. guideline EP7-A2 'Interference testing in clinical chemistry; Approved Guideline Second Edition'. 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 LDL Cholesterol concentrations of 96.75 mg/dl and 193.5 mg/dl and found not to interfere:
| Hemoglobin | No significant interference up to 1000mg/dl. |
|---|---|
| Total Bilirubin | No significant interference up to 60mg/dl. |
| Conjugate Bilirubin | No significant interference up to 60mg/dl. |
| Triglycerides | No significant interference up to 500mg/dl. |
| Intralipid® | No significant interference up to 500mg/dl. |
| Ascorbic Acid | No significant interference up to 6mg/dl. |
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'.
The candidate device on the RX Daytona Plus analyzer, was tested against the predicate device on the RX Imola analyzer.
139 serum patient samples spanning the range 22.45 to 735.68 mg/dl were tested by two operators on two lots of LDL cholesterol reagent, across 3 working days with each sample tested in singlicate.
The candidate device was compared to the predicate device and the following linear regression equation was obtained:
Y = 1.01x - 1.45 Correlation coefficient of r = 0.998
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q. Matrix comparison:
Matrix method comparisons for the LDL cholesterol assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of LDL cholesterol reagents. Both serum and lithium heparin plasma were tested to determine whether method accuracy with plasma specimens are equivalent to serum results and that lithium heparin plasma does not interfere with either the method or the system.
LDL 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). 70 matched patient sample pairs were analyzed spanning the range 25.45 to 665.64 mg/dl and the following linear regression equation was obtained:
Y = 1.01x -2.81 Correlation coefficient of r = 0.998
Expected values/Reference range:
Referenced from literature
Table 4 Reference Ranges
| Analyte | Serum |
|---|---|
| LDL Cholesterol (3) | 190 mg/dL very high |
- 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). NIH Publication No. 02-5215 September 2002
10. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.