(622 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring Lp(a) levels using immunoturbidimetry on an automated analyzer. There is no mention of AI, ML, or any computational analysis beyond standard data processing for quantitative measurements.
No
This device is an in vitro diagnostic assay used for the quantitative measurement of lipoprotein (a) to evaluate lipid metabolism disorders and assess cardiovascular disease risk. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is for "in vitro diagnostic use" and that "The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease". This indicates its purpose is to aid in the diagnosis of medical conditions.
No
The device description clearly states it is composed of "2 ready to use liquid reagents" supplied in plastic vials, which are physical components, not software. It is an in vitro diagnostic assay kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Lp(a) Ultra assay is intended for in vitro diagnostic use..." and "For In Vitro Diagnostic use."
- Nature of the Assay: The device is an assay designed to measure a specific substance (lipoprotein (a) [Lp(a)]) in human biological samples (serum and plasma) outside of the body ("in vitro").
- Purpose: The measurement is intended to be used in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease, which are clinical purposes.
Therefore, based on the provided information, the Lp(a) Ultra assay is definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitation of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation.
For In Vitro Diagnostic use.
Product codes
DFC
Device Description
Lp(a) Ultra assay is composed by 2 ready to use liquid reagents (Reagent 1and Reagent 2) that are supplied in the following configuration: Reagent 1 fill volume 18 mL in a 20 mL wedge and Reagent 2 fill volume 9 mL in a 20 mL wedge, 1 wedge of each/kit.
The kit contains one plastic (HDPE) vial of Reagent 1 and one plastic (HDPE) vial of Reagent 2, which allows the customer to perform 86 tests (on AU680 automatic analyzer).
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 (Repeatability/Reproducibility)
Inter-Assay Precision (Total Imprecision)
- Study Type: Inter-Assay Precision study based on CLSI EP05-A3 Guideline.
- Sample Size: Five samples at different concentrations (20 mg/dL to 100 mg/dL). 2 replicates of each sample performed on 2 different runs per day for 28 testing days.
- Key Results:
- Lot 90530, Level 1: Total %CV = 4.6%
- Lot 90530, Level 2: Total %CV = 3.2%
- Lot 90530, Level 3: Total %CV = 5.3%
- Lot 90530, Level 4: Total %CV = 3.3%
- Lot 90530, Level 5: Total %CV = 2.3%
- Key Metrics: Good precision across the concentration range from 20 to 100 mg/dL.
Intra-Assay Precision (Within Run)
- Study Type: Intra-Assay Precision study based on CLSI EP15-A3 Guideline.
- Sample Size: Five samples at different concentrations (20 mg/dL to 100 mg/dL). 20 replicates of each sample run on 3 different runs.
- Key Results: All calculated CV% are lower than 5%.
Linearity
Linearity - Analytical Measuring Range
- Study Type: Linearity evaluation based on CLSI EP06.
- Key Results: The assay is linear up to 100 mg/dL. The upper limit of the AMR is 100 mg/dL. The AMR is claimed as 10 mg/dL to 100 mg/dL.
Analytical Sensitivity/Detection Limit
Limit of Blank (LoB) Study
- Study Type: LoB study based on CLSI EP17-A2.
- Sample Size: For two reagent lots, 4 saline samples (zero-analyte samples) were tested in 5 replicates in three different runs, for a total of 60 measurements for each lot.
- Key Results:
- Lot 90266: LoB = 0.7 mg/dL
- Lot 90530: LoB = 0.7 mg/dL
- Key Metrics: The observed LoB supports the claim of 0.7 mg/dL.
Limit of Detection (LoD) Study
- Study Type: LoD study based on CLSI EP17-A2.
- Key Results:
- Reagent 90266: LoD = 1.6 mg/dL
- Reagent 90530: LoD = 1.9 mg/dL
- Key Metrics: The LoD value observed supports the claim of 1.9 mg/dL.
Limit of Quantitation (LoQ) Study
- Study Type: LoQ study based on CLSI EP17-A2.
- Key Results:
- Lot 90266: LoQ = 2.5 mg/dL
- Lot 90530: LoQ = 3.0 mg/dL
- Key Metrics: The LoQ observed supports the claim of 3.0 mg/dL.
Interference
Endogenous Interferences Study
- Study Type: Interference study based on EP07 3rd Edition.
- Key Results: No significant interference observed for Intralipid®, conjugated bilirubin, unconjugated bilirubin, Rheumatoid Factor, Hemoglobin, and Ascorbic Acid up to tested concentrations. Triglycerides showed no significant interference at concentrations ranging from 461 to 715 mg/dL.
Stability
On Board Calibration Study
- Study Type: Stability study based on CLSI EP25-A Guideline.
- Sample Size: 5 samples at different concentrations (20 mg/dL to 100 mg/dl).
- Key Metrics: The Calibration Stability claim is 15 days on the AU 680 Analyzer. The on-board stability claim is 30 days on the AU680 analyzer.
Other Analytical Performance
Prozone Study
- Study Type: High Dose Hook Effect (Prozone) study.
- Key Results: No Prozone effect was observed up to a concentration of 500.0 mg/dL. No prozone effect up to the upper limit of the measuring range is claimed.
Comparison Studies
Method Comparison vs. Predicate Device
- Study Type: Method comparison study based on CLSI document EP09c 3rd Edition.
- Sample Size: Not explicitly stated, but implicitly involved testing the Lp(a) Ultra assay on Beckman Coulter AU680 against Diazyme® Lipoprotein (a), REF DZ131B-K, on VITROS® 4600.
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results:
- r = 0.995 (Passing & Bablok fit and Linear fit)
- Slope (Passing & Bablok fit) = 0.9850 (0.9706 - 1.0000)
- Slope (Linear fit) = 0.9771 (0.9612 - 0.9929)
Matrix Comparison - Lithium Heparin
- Study Type: Matrix comparison study based on CLSI document EP09c 3rd Edition.
- Sample Size: 57 serum and Lithium Heparin plasma samples, derived from the same patients, tested in duplicate.
- Key Results:
- r = 0.997 (Passing & Bablok fit and Linear fit)
- Slope (Passing & Bablok fit) = 0.99 (0.95 - 1.03)
- Slope (Linear fit) = 0.98 (0.95 – 1.00)
Matrix Comparison - Sodium Heparin
- Study Type: Matrix comparison study based on CLSI document EP09c 3rd Edition.
- Sample Size: 58 serum and Sodium Heparin plasma samples, derived from the same patients, tested in duplicate.
- Key Results:
- r = 0.999 (Passing & Bablok fit and Linear fit)
- Slope (Passing & Bablok fit) = 0.99 (0.95 – 1.01)
- Slope (Linear fit) = 0.99 (0.97 - 1.00)
Matrix Comparison - Di-Potassium EDTA
- Study Type: Matrix comparison study based on CLSI document EP09c 3rd Edition.
- Sample Size: 57 serum and Di-Potassium EDTA plasma samples, derived from the same patients, tested in duplicate.
- Key Results:
- r = 0.997 (Passing & Bablok fit and Linear fit)
- Slope (Passing & Bablok fit) = 0.97 (0.95 - 1.01)
- Slope (Linear fit) = 0.98 (0.96 - 1.00)
Matrix Comparison - Tri-Potassium EDTA
- Study Type: Matrix comparison study based on CLSI document EP09c 3rd Edition.
- Sample Size: 56 serum and Tri-Potassium EDTA plasma samples, derived from the same patients, tested in duplicate.
- Key Results:
- r = 0.998 (Passing & Bablok fit and Linear fit)
- Slope (Passing & Bablok fit) = 0.99 (0.95 - 1.03)
- Slope (Linear fit) = 0.99 (0.98 - 1.01)
Key Metrics
- Total %CV: 2.3% to 5.3% for Inter-Assay Precision.
- Intra-Assay CV%: Lower than 5% for all tested runs/levels.
- Analytical Measuring Range (AMR): 10 mg/dL to 100 mg/dL.
- Limit of Blank (LoB): 0.7 mg/dL.
- Limit of Detection (LoD): 1.9 mg/dL.
- Limit of Quantitation (LoQ): 3.0 mg/dL.
- Correlation Coefficient (r): 0.995 for Method Comparison. Ranging from 0.997 to 0.999 for Matrix Comparisons.
- Slope: Between 0.97 and 0.99 for all comparison studies.
- Calibration Stability: 15 days on AU 680 Analyzer.
- On-board Stability: 30 days on AU680 Analyzer.
- Prozone Effect: Not observed up to 500.0 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2022
SENTINEL CH. S.p.A. Patricia Dupé Head of Quality System Via Robert Koch 2 Milan, 20152 Italy
Re: K211058
Trade/Device Name: Lp(a) Ultra Regulation Number: 21 CFR 866.5600 Regulation Name: Low-Density Lipoprotein Immunological Test System Regulatory Class: Class II Product Code: DFC Dated: August 5, 2022 Received: August 5, 2022
Dear Patricia Dupé:
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 medical devices and radiation-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, Digitally signed by Paula Caposino -S Date: 2022.12.22 Paula Caposino, Ph.D. Acting Deputy 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K211058
Device Name Lp(a) Ultra
Indications for Use (Describe)
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitation of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation.
For In Vitro Diagnostic use.
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
se, including the of information is estimated to average 79 hours per 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."
3
510(k) SUMMARY
1. Applicant Name
SENTINEL CH. S.p.A. Via Robert Koch, 2 Milano (MI) 20152, Italy +39 02 345 514 1
Primary contact person for all communications:
Patricia Dupé Head of Quality System Phone: +39 02 34 551 496 Fax: +39 02 34 551 464 Email: patriciadupe@sentinel.it
2. Device Name and Classification
Trade name: Lp(a) Ultra Device Classification: Class II Regulation: 21CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Product Code: DFC Device Name: Lipoprotein, Low-Density, Antigen, Antiserum, Control Medical Specialty: Immunology
3. Predicate Device
Diazyme Lipoprotein (a) Assay (K180074)
4. Indications for Use
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation.
For In Vitro Diagnostic use.
4
5. Intended Use
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation.
For In Vitro Diagnostic use.
6. Description
Lp(a) Ultra assay is composed by 2 ready to use liquid reagents (Reagent 1and Reagent 2) that are supplied in the following configuration: Reagent 1 fill volume 18 mL in a 20 mL wedge and Reagent 2 fill volume 9 mL in a 20 mL wedge, 1 wedge of each/kit.
The kit contains one plastic (HDPE) vial of Reagent 1 and one plastic (HDPE) vial of Reagent 2, which allows the customer to perform 86 tests (on AU680 automatic analyzer).
7. Principles of the Procedure
Lp(a) Ultra is a latex-based immunoturbidimetric assay developed to measure Lp(a) levels in serum and plasma.
When an antigen-antibody reaction occurs between Lp(a) in a sample and anti-Lp(a) antibody which has been adsorbed to latex particles, agglutination results. This agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of La(a) contained in the sample.
8. Comparison with Predicate Device
The comparison between Lp(a) Ultra and the predicate device Diazyme Lipoprotein (a) Assay is reported in Table 8.1.
5
Table 8.1. Comparison Lp(a) Ultra vs. Predicate Device Diazyme Lipoprotein (a) Assay
| Characteristics | Subject Device | Predicate Device K180074 |
|---|---|---|
| Lp(a) Ultra | Diazyme Lipoprotein (a) Assay | |
| Technical Characteristics | ||
| Classification | Regulation Description: Low-density lipoprotein | |
| immunological test system | Same | |
| Method Principle | Quantitative immunoturbidimetric assay | Same |
| Intended Use | The Lp(a) assay is intended for in vitro diagnostic use in | |
| the immunoturbidimetric quantitative determination of | ||
| lipoprotein (a) [Lp(a)] in human serum and plasma using | ||
| an automated analyzer. | ||
| The measurement of Lp(a) is useful in evaluating lipid | ||
| metabolism disorders and assessing atherosclerotic | ||
| cardiovascular disease in specific populations, when used | ||
| in conjunction with clinical evaluation. | ||
| For In Vitro Diagnostic use. | The Diazyme Lipoprotein (a) Assay is intended as a latex particle | |
| enhanced immunoturbidimetric assay for the in vitro quantitative | ||
| determination of Lipoprotein (a) [Lp(a)] concentration in human | ||
| serum or plasma on Clinical Chemistry Systems. The | ||
| measurement of Lipoprotein (a) is useful in evaluating lipid | ||
| metabolism disorders and assessing atherosclerotic | ||
| cardiovascular diseases in specific populations, when used in | ||
| conjunction with clinical evaluation. For in vitro diagnostic use | ||
| only. | ||
| Analyte Measured | Lipoprotein (a) | Same |
| Instrument Used | Beckman Coulter AU680 | Ortho Clinical Diagnostics VITROS 4600 |
| Measurement | Quantitative | Same |
| Specimen Type | Serum, plasma (Na-heparin, Li-heparin, K2-EDTA, K3- | |
| EDTA) | Serum, plasma (Li-Heparin, K2EDTA) | |
| Reference Values | Lp(a) 2nd aliquot: Control Sample (Low Test Sample) |
The study was divided in two procedures:
-
- Paired Difference Tests
Test Sample and Control Sample were tested in different replicates. If there is no interferences the study was concluded. If Interference is confirmed, proceed with the 'Interference test'
- Paired Difference Tests
-
- Interference test
The Test Sample aliquots were diluted using the Control Sample to obtain additional dilution levels in the ratio ranging from 100% to 0%
- Interference test
9.4.1.1. Results
A summary of the results is presented in Table 9.4.1.
| Interfering substance | Tested
concentration
up to | Observed
concentration
without
Interferences
Pool Low | Observed
concentration
without
Interferences
Pool High |
|-------------------------------------|----------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------|
| Intralipid® Sterile Fat
Emulsion | 1000 mg/dL | 1000 mg/dL | 1000 mg/dL |
| Triglycerides | 1000 mg/dL | 715 mg/dL * | 715 mg/dL * |
| Conjugated bilirubin | 60 mg/dL | 60 mg/dL | 60 mg/dL |
| Unconjugated bilirubin | 60 mg/dL | 60 mg/dL | 60 mg/dL |
| Rheumatoid Factor | 500 UI/mL | 500 UI/mL | 500 UI/mL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL | 1000 mg/dL |
| Ascorbic Acid | 180 mg/dL | 180 mg/dL | 180 mg/dL |
Table 9.4.1. Interferences Results Summary
- Triglycerides was tested in patient serum samples without significant interference at triglycerides concentration ranging from 461 to 715 mg/dL.
| 510(k) SUMMARY | Page 9 of 13 |
|---|---|
| ---------------- | -------------- |
12
9.5. Stability
9.5.1. On Board Calibration Study
The Stability study allows to verify the On Board and the Calibration Stability of the product.
The On Board and the Calibration Stability were determined on the basis of CLSI EP25-A Guideline (Evaluation of Stability of in Vitro Diagnostics Reagents).
For the study, 5 samples were used at different concentration ranging from 20 mg/dL to 100 mg/dl.
9.5.1.1. Results
A summary of the results is presented in Table 9.5.1.
| Reagent | Material | %bias
Min | % bias
Max |
|-----------|----------|--------------|---------------|
| Lot 90530 | Level 1 | -2.7% | 5.1% |
| | Level 2 | -0.7% | 1.4% |
| | Level 3 | -4.8% | 0.7% |
| | Level 4 | -3.4% | 1.0% |
| | Level 5 | -1.3% | 1.1% |
Table 9.5.1. On Board Calibration Results
The Calibration Stability claim is 15 days on the AU 680 Analyzer. The on-board stability claim is 30 days on the AU680 analyzer.
9.6. Other Analytical Performance
9.6.1. Prozone Study
The High Dose Hook Effect (Prozone) study was performed to determine the analyte concentration at which false negatives results may occur.
For the study, the last calibrator level of calibrator set reconstituted with 191 µL was used to reach a high concentration (approx. 500.0 mg/dL).
The sample was diluted in saline to obtain some concentration points within the analytical measuring range.
9.6.1.1. Results
No Prozone effect was observed up to concentration of 500.0 mg/dL. No prozone effect up to the upper limit of the measuring range is claimed.
13
9.7. Comparison Studies
9.7.1. Method Comparison vs. Predicate Device
Purpose of this study is to evaluate the performances of Lp(a) Ultra assay on Beckman Coulter AU680 Analyzer, compared to the predicate device Diazyme® Lipoprotein (a), REF DZ131B-K, on VITROS® 4600, Ortho Clinical Diagnostics.
The method comparison study was performed based on guidance from the CLSI document EP09c 3rd Edition.
9.7.1.1. Results
A summary of the results is presented in Table 9.7.1.
| | Results
- Passing & Bablok fit | Results
- Linear fit- |
|-------|-----------------------------------|-----------------------------|
| r | 0.995 | 0.995 |
| Slope | 0.9850
(0.9706 - 1.0000) | 0.9771
(0.9612 - 0.9929) |
Table 9.7.1. Method Comparison vs. Predicate Device Results
9.7.2. Matrix Comparison - Lithium Heparin
This study was performed to demonstrate correlation between Serum samples and Plasma Lithium Heparin samples.
The Matrix Comparison study was performed based on guidance from the CLSI document EP09c 3rd Edition.
57 serum and Lithium Heparin plasma samples, derived from the same patients were tested in duplicate.
9.7.2.1. Results
A summary of the results is presented in Table 9.7.2.
Table 9.7.2. Matrix Comparison - Lithium Heparin Results
| | Results
- Passing & Bablok fit - | Results
- Linear fit- |
|-------|-------------------------------------|--------------------------|
| r | 0.997 | 0.997 |
| Slope | 0.99
(0.95 - 1.03) | 0.98
(0.95 – 1.00) |
14
9.7.3. Matrix Comparison - Sodium Heparin
This study was performed to demonstrate correlation between Serum samples and Plasma Sodium Heparin samples.
The method comparison study was performed based on guidance from the CLSI document EP09c 3tt Edition.
58 serum and Sodium Heparin plasma samples, derived from the same patients were tested in duplicate.
Results 9.7.3.1.
A summary of the results is presented in Table 9.7.3.
| | Results
- Passing & Bablok fit - | Results
- Linear fit- |
|-------|-------------------------------------|--------------------------|
| r | 0.999 | 0.999 |
| Slope | 0.99
(0.95 – 1.01) | 0.99
(0.97 - 1.00) |
Table 9.7.3. Matrix Comparison - Sodium Heparin Results
9.7.4. Matrix Comparison - Di-Potassium EDTA
This study was performed to demonstrate correlation between Serum samples and Plasma Di-Potassium EDTA samples.
The Matrix Comparison study was performed based on guidance from the CLSI document EP09c 3rd Edition.
57 serum and Di-Potassium EDTA plasma samples, derived from the same patients were tested in duplicate.
9.7.4.1. Results
A summary of the results is presented in Table 9.7.4.
Table 9.7.4. Matrix Comparison - Di-Potassium EDTA Results
| | Results
- Passing & Bablok fit - | Results
- Linear fit- |
|-------|-------------------------------------|--------------------------|
| r | 0.997 | 0.997 |
| Slope | 0.97
(0.95 - 1.01) | 0.98
(0.96 - 1.00) |
15
9.7.5. Matrix Comparison - Tri-Potassium EDTA
This study was performed to demonstrate correlation between Serum samples and Plasma Tri-Potassium EDTA samples.
The method comparison study was performed based on guidance from the CLSI document EP09c 3rd Edition.
56 serum and Tri-Potassium EDTA plasma samples, derived from the same patients were tested in duplicate.
9.7.5.1. Results
A summary of the results is presented in Table 9.7.5.
| Results | Results | |
|---|---|---|
| - Passing & Bablok fit - | - Linear fit- | |
| r | 0.998 | 0.998 |
| Slope | 0.99 | |
| (0.95 - 1.03) | 0.99 | |
| (0.98 - 1.01) |
Table 9.7.5. Matrix Comparison – Tri-Potassium EDTA Results
CONCLUSIONS 10.
Testing results indicate that the proposed device Lp(a) Ultra is substantially equivalent to the predicate device.
| 510(k) SUMMARY | Page 13 of 13 |
|---|---|
| ---------------- | --------------- |