(132 days)
For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
The Randox Triglycerides kit assay consists of ready to use reagent solutions.
Here's a breakdown of the acceptance criteria and the study information for the Triglycerides (TRIGS) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of "acceptance criteria" for the entire device's performance followed by a direct comparison in a single table, but rather describes various performance characteristics and their findings. I will construct a table based on the individual performance criteria and the results presented.
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Not explicitly stated as a single numerical criterion. Evaluated consistent with C.L.S.I documents EP5-A2. Implied goal is acceptable variability across runs, days, and total. | Lot 1 (RX Daytona Plus): - Sensitivity Pool (13.3 mg/dl): Total CV 13.4% - Serum Pool 1 (96.4 mg/dl): Total CV 2.1% - QC 1 (96.5 mg/dl): Total CV 2.3% - Patient Pool 2 (104 mg/dl): Total CV 2.5% - Patient Pool 1 (117 mg/dl): Total CV 2.5% - Serum Pool 2 (237 mg/dl): Total CV 2.1% - CAL (240 mg/dl): Total CV 2.0% - QC 2 (259 mg/dl): Total CV 1.5% - Serum Pool 3 (326 mg/dl): Total CV 1.6% Lot 2 (RX Daytona Plus): - Sensitivity Pool (17.7 mg/dl): Total CV 11.6% - 801UN QC 2 (97.3 mg/dl): Total CV 3.2% - Serum Pool 1 (111 mg/dl): Total CV 3.6% - 832UE CAL (235 mg/dl): Total CV 3.0% - Serum Pool 2 (252 mg/dl): Total CV 2.6% - 587UE QC 3 (265 mg/dl): Total CV 2.5% - Serum Pool 3 (326 mg/dl): Total CV 3.7% - Serum Pool 4 (514 mg/dl): Total CV 2.8% |
| Linearity/Assay Reportable Range | Deviation from linearity less than 5%. | Linearity: Slope 0.96, Intercept 3.30, r = 1.000. Reportable Range: 12.4 – 1000 mg/dl. (The linearity study covered up to approximately 1000 mg/dl, and the device has an auto-dilution feature for samples >1000 mg/dL). |
| Detection Limit | Not explicitly stated as acceptance criteria, but rather defined properties. | LoD: 3.96 mg/dl (based on 240 determinations, 4 low-level samples) LoB: 2.65 mg/dl LoQ: 12.4 mg/dl (lowest concentration at which precision is met) |
| Analytical Specificity (Interference) | Recovery within ±10% of the initial value of Triglycerides concentration of 150mg/dL and 496mg/dL. | Hemoglobin: 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 Ascorbic Acid: No significant interference up to 3.0mg/dL |
| Method Comparison with Predicate Device | Not explicitly stated as a single numeric criterion for the regression, but the goal is "substantially equivalent" to the predicate. Implied acceptable correlation (r) and agreement (slope, intercept). | Comparison: Y = 0.97x + 1.22 Correlation coefficient: r = 0.999 (This indicates a very strong positive correlation) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Reproducibility:
- Test Set: Serum-based control material and unaltered human serum samples (some spiked or diluted). Specific numbers of individual patient samples beyond "Pool 1, Pool 2, Pool 3, Pool 4" are not given. For each sample type, 2 replicates per run were performed, twice daily for 20 non-consecutive days, using 2 reagent lots and 2 systems.
- Data Provenance: Not explicitly stated, but implies laboratory testing with control materials and human serum samples. Given the manufacturer is based in the UK, it's likely the testing was done there, but this is not confirmed. It is a prospective study design for precision.
- Linearity:
- Test Set: 11 levels prepared from low and high serum pools, each run in replicates of five.
- Data Provenance: Not explicitly stated, but implies laboratory testing with serum pools. Prospective study design.
- Detection Limit:
- Test Set: 240 determinations were made, including 4 low-level samples, to determine LoD, LoB, and LoQ.
- Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
- Analytical Specificity (Interference):
- Test Set: Spiked interferent samples with corresponding control solutions. Specific number of samples not provided. Triglycerides concentrations of 150 mg/dL and 496 mg/dL were examined.
- Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
- Method Comparison:
- Test Set: 109 serum patient samples spanning the range 14.2 to 986 mg/dl. Each tested in singlicate.
- Data Provenance: Not explicitly stated (e.g., country of origin), but states "serum patient samples." Implies retrospective collection of samples or prospective collection for this study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device (Triglycerides assay) is an in-vitro diagnostic device for quantitative chemical analysis. The "ground truth" for these types of devices is established through analytical reference methods or highly characterized reference materials, not typically by expert consensus of human readers.
- No mention of human experts or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative analytical assay. Adjudication is typically used in image-based diagnostic studies involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves assessing the performance of human readers, sometimes with and without AI assistance, and is not relevant for a quantitative chemical assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described (precision, linearity, detection limit, analytical specificity, method comparison) represent the standalone performance of the device/system (RX Daytona plus analyzer with Randox Triglycerides reagent) without human intervention in the analytical measurement process beyond sample loading and general operation.
7. The Type of Ground Truth Used
- Precision/Reproducibility, Linearity, Detection Limit, Analytical Specificity: The "ground truth" or reference for these studies refers to the true concentration of triglycerides in the samples (control materials, spiked samples, diluted samples) as determined by a highly accurate method or known values of reference materials.
- Method Comparison: The "ground truth" is the results obtained by a legally marketed predicate device (Randox Triglyceride Assay, K923508). For calibrators within the system, Randox Calibration Serum Level 3 is stated to be traceable to the Triglycerides reference method ID-GC/MS. This indicates a high-accuracy chemical method is the ultimate ground truth for calibration.
8. The Sample Size for the Training Set
This document describes a medical device (an in-vitro diagnostic reagent/system) for which "training sets" are not typically applicable in the same way as for AI/machine learning algorithms. The device's performance characteristics are inherent to its chemical formulation and the analytical instrument. There is no mention of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" for an algorithm mentioned in the context of this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND ROAD CRUMLIN BT29 4QY, GREAT BRITAIN
Re: K150819
Trade/Device Name: Triglycerides (TRIGS) Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride test system Regulatory Class: Class I, meets the limitation of exemption 21 CFR §862.9(c)(4) Product Code: CDT Dated: June 18, 2015 Received: June 22, 2015
Dear 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, 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.
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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 yours.
Courtney H. Lias -S
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
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Indications for Use
510(k) Number (if known)
K150819 Device Name Triglycerides (TRIGS)
Indications for Use (Describe)
For the quantitative in vitro determination of Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY, TRIGLYCERIDES ASSAY
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: July 9, 2015
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K150819
Device Proprietary Name: Triglycerides (TRIGS)
Common Name: Triglycerides
Purpose for Submission: New Device
| ProductCode | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| CDT | Triglycerides testsystem | I, meets thelimitations toexemptions 21CFR §862.9 (c)(4) | 21 CFR862.1705 | ClinicalChemistry(75) |
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Randox Laboratories Ltd. Triglycerides reagent
510 (k) Number: K923508
5. INTENDED USE
For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
6. DEVICE DESCRIPTION
The Randox Triglycerides kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: TR8332
R1. Enzyme Reagent 4 x 20 ml
REAGENT COMPOSITION
| Contents | Initial Concentration |
|---|---|
| R1. Enzyme ReagentPipes buffer4-chloro-phenolMagnesium ions4- aminophenazoneATPLipasesGlycerol kinaseGlycerol-3-phosphate oxidasePeroxidaseSodium azide | 38.7 mmol/L, pH 7.53.4 mmol/L16.9 mmol/L0.25 mmol/L1.2 mmol/L≥ 10 u/mL≥ 0.4 u/mL≥ 1.5 u/mL≥ 0.5 u/mL0.05% |
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)
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7. PREDICATE DEVICE COMPARISON TABLE
Table 1 Comparison of Triglycerides test system for the RX Daytona plus to predicate device
| CHARACTERISTICS | Randox Triglycerides Assay forRX daytona plus(New Device) | RandoxTriglyceride Assay(K923508)(Predicate Device) |
|---|---|---|
| Similarities | ||
| INTENDED USE | For the quantitative in vitro determination ofTriglycerides in serum. Triglyceridemeasurements are used in the diagnosis andtreatment of diseases involving lipidmetabolism and various endocrine disorderse.g Diabetes mellitus, nephrosis and liverobstruction | Same |
| ASSAY PROTOCOL | Colorimetric Method | Same |
| STORAGE(UNOPENED) | Reagents are stable up to the expiry datewhen stored unopened at +2 to +8°C | Same |
| CONTROLFREQUENCY | Randox assayed human multisera Level 2 & 3Two levels of control should be assayed atleast once a day | Same |
| CALIBRATIONFREQUENCY | Every 28 days, with a change ofreagent lot or as indicated by quality controlprocedures. | Same |
| Differences | |||
|---|---|---|---|
| REAGENTCOMPOSITION | R1. Enzyme ReagentPipes bufferpH 7.54-chloro-phenolMagnesium ions4- aminophenazoneATPLipasesGlycerol kinaseGlycerol-3-phosphate oxidasePeroxidaseSodium azide | 38.7 mmol/L3.4 mmol/L16.9 mmol/L0.25 mmol/L1.2 mmol/L≥ 10 u/mL≥ 0.4 u/mL≥ 1.5 u/mL≥ 0.5 u/mL0.05% | R1a. BufferPipes Buffer 40 mmol/l, pH 7.54-chloro-phenol 5.0 mmol/lMagnesium-ions 5.0 mmol/lR1b. Enzyme Reagent4-aminophenazone 0.4 mmol/lATP 1.0 mmol/lLipases ≥150 U/mlGlycerol-kinase ≥ 0.4 U/mlGlycerol-3-phosphateoxidase ≥ 1.5 U/mlPeroxidase ≥ 0.5 U/ml |
| TEST RANGE | 12.4 - 1000mg/dl | 11.5 - 1133mg/dl | |
| SAMPLE TYPE | Serum | Serum, heparinized plasma and EDTAplasma samples are suitable. |
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8. TEST PRINCIPLE
The Triglycerides 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 and read at 510nm.
Image /page/6/Figure/2 description: This image shows four chemical reactions. The first reaction shows triglycerides reacting with H20 to produce glycerol and fatty acids, with Lipases as the catalyst. The second reaction shows glycerol reacting with ATP to produce glycerol-3-phosphate and ADP, with GK as the catalyst. The third reaction shows glycerol-3-phosphate reacting with O2 to produce dihydroxyacetone, phosphate, and H202, with GPO as the catalyst. The fourth reaction shows 2H20 reacting with 4-aminophenazone and 4 chlorophenol to produce quinoneimine, HCl, and 4 H20, with POD as the catalyst.
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 serum based control material and unaltered human serum samples that were spiked with triglycerides concentrations or diluted to achieve concentrations based on established ranges <150 mg/dl normal triglycerides level : 150 – 199 ma/dl borderline high triglycerides level: 200 – 499 mg/dl high triglycerides level and ≥ 500 mg/dl very high triglycerides level. Testing was conducted for two reagent lots of triglycerides, 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.
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| System: RX Daytona Plus | Within Run | Among Run | Among Day | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MethodLot 1 | Product | MEAN(mg/dl) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) |
| Triglycerides | SensitivityPool | 13.3 | 0.88 | 8.0 | 0.00 | 2.8 | 1.77 | 10.3 | 4.42 | 13.4 |
| Triglycerides | SerumPool 1 | 96.4 | 1.77 | 1.9 | 0.88 | 0.6 | 0.88 | 0.8 | 1.77 | 2.1 |
| Triglycerides | QC 1 | 96.5 | 1.77 | 1.8 | 0.88 | 1.0 | 0.88 | 1.0 | 1.77 | 2.3 |
| Triglycerides | PatientPool 2 | 104 | 1.77 | 2.1 | 0.88 | 1.1 | 0.88 | 1.0 | 2.65 | 2.5 |
| Triglycerides | PatientPool 1 | 117 | 2.65 | 2.3 | 0.88 | 0.6 | 0.88 | 0.6 | 2.65 | 2.5 |
| Triglycerides | SerumPool 2 | 237 | 4.42 | 1.9 | 0.00 | 0.0 | 1.77 | 0.8 | 7.08 | 2.1 |
| Triglycerides | CAL | 240 | 3.54 | 1.5 | 3.54 | 1.3 | 0.00 | 0.0 | 4.42 | 2.0 |
| Triglycerides | QC 2 | 259 | 3.54 | 1.3 | 0.88 | 0.2 | 1.77 | 0.7 | 3.54 | 1.5 |
| Triglycerides | SerumPool 3 | 326 | 4.42 | 1.4 | 1.77 | 0.5 | 1.77 | 0.5 | 4.42 | 1.6 |
Table 2 Precision Summary
| System: RX Daytona Plus | Within Run | Among Run | Among Day | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| MethodLot 2 | Product | MEAN(mg/dl) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) |
| Triglycerides | SensitivityPool | 17.7 | 0.88 | 4.6 | 0.88 | 6.1 | 4.42 | 8.7 | 1.77 | 11.6 |
| Triglycerides | 801UNQC 2 | 97.3 | 2.65 | 2.5 | 0.00 | 0.5 | 1.77 | 2.0 | 3.54 | 3.2 |
| Triglycerides | SerumPool 1 | 111 | 2.65 | 2.2 | 1.77 | 1.8 | 2.65 | 2.2 | 3.54 | 3.6 |
| Triglycerides | 832UECAL | 235 | 5.31 | 2.4 | 0.00 | 0.0 | 4.42 | 1.8 | 7.08 | 3.0 |
| Triglycerides | SerumPool 2 | 252 | 3.54 | 1.6 | 4.42 | 1.6 | 3.54 | 1.3 | 6.19 | 2.6 |
| Triglycerides | 587UEQC 3 | 265 | 4.42 | 1.7 | 2.65 | 1.0 | 4.42 | 1.6 | 6.19 | 2.5 |
| Triglycerides | SerumPool 3 | 326 | 7.08 | 2.1 | 7.08 | 2.1 | 7.08 | 2.1 | 12.4 | 3.7 |
| Triglycerides | SerumPool 4 | 514 | 11.5 | 2.2 | 0.00 | 0.0 | 7.96 | 1.6 | 14.2 | 2.8 |
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b. Linearity/assav 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. The sponsor set a range from 12.4 mg/dl analyte concentration up to a high concentration approximately 1000mg/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 Triglycerides reagent on one RX Daytona plus system. The observed values were compared to the expected values; 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 graph shows the relationship between the level and the mean result. There are two lines on the graph, one representing the linear fit to levels 1-5 and the other representing the linear fit to levels 2-5. Both lines show a positive correlation between the level and the mean result.
| Slope | 0.96 |
|---|---|
| Intercept | 3.30 |
| r | 1.000 |
| Analyte | Linearity | Reportable Range |
|---|---|---|
| Triglycerides | 1000 mg/dl | 12.4 – 1000 mg/dl |
The low end of the reportable assay range is based on the Limit of Quantitation. The high end of the reportable assay range is based on the linearity.
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The Rx Daytona Plus analyzer has an auto-dilution feature that is automatically activated when measuring samples >1000 mg/dL, which are diluted and remeasured to obtain values within the measuring range.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Refer to K053153 Calibrator and K942458 Control for Triglycerides.
Randox Calibration Serum Level 3 is traceable to Triglycerides reference method ID-GC/MS.
d. Detection limit:
Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2 'Evaluation of detection capability for clinical laboratory measurement procedures; Approved Guideline Second Edition'. 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 Triglycerides on the RX Daytona Plus is 3.96 mg/dl based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 2.65 mg/dl.
The Limit of Quantitation (LoQ) is 12.4 mg/dl as determined by the lowest concentration at which precision is still met.
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:
The criteria for no significant interference is recovery within ±10% of the initial value of Triglycerides concentration of 150mg/dL and 496mg/dL
| Haemoqlobin | No significant interference up to 750mg/dL |
|---|---|
| Total Bilirubin | No significant interference up to 60mg/dL |
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Coniugate Bilirubin No significant interference up to 60mg/dL Ascorbic Acid No significant interference up to 3.0mg/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'.
109 serum patient samples spanning the range 14.2 to 986 mg/dl were tested by two operators on two lots of Triglycerides reagent on one RX Daytona plus analyzer and the predicate device tested on 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 = 0.97x + 1.22 Correlation coefficient of r = 0.999
Expected values/Reference range:
The NCEP (American National Cholesterol Education Program) has established the following classification for triglyceride levels according to the risk of developing coronary heart diseases:
Table 4 Reference Ranges
| Analyte | Expected Values |
|---|---|
| Triglycerides (1) | Normal < 150 mg/dlBorderline-high 150 – 199 mg/dlHigh 200 – 499 mg/dlVery High ≥ 500 mg/dl |
- ATP III Guidelines At-A-Glance Quick Desk Reference, National Cholesterol Education
Program. National Institute of Health Publication No. 01-3305. May 2001.
10. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.