(162 days)
No
The summary describes a standard in vitro diagnostic assay kit for measuring Total Bilirubin using chemical reagents and a laboratory analyzer (RX Daytona plus). There is no mention of AI, ML, or any computational methods beyond standard statistical analysis for performance studies.
No.
This device is an in vitro diagnostic device used to measure Total Bilirubin, which aids in the diagnosis of certain disorders but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" states that "Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis." This directly indicates its role in diagnosis. Furthermore, the document explicitly refers to the device as an "in vitro diagnostic device."
No
The device is an in vitro diagnostic (IVD) reagent kit consisting of chemical solutions, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For the quantitative in vitro determination of Total Bilirubin for serum and plasma." and "This in vitro diagnostic device is intended for prescription use only." This clearly indicates the device is used to test samples in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a "Total Bilirubin kit assay" consisting of reagent solutions used for testing biological samples.
- Performance Studies: The document describes various performance studies (Precision, Linearity, Detection limit, Analytical Specificity, Method comparison, Matrix comparison, Expected values/Reference range) which are standard evaluations for IVD devices to demonstrate their analytical performance and suitability for diagnostic use.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K063845) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as comparisons to previously cleared devices are a common part of the process.
- Reference Device(s): The listed reference devices (K942458 and K053153) are also IVD products (control and calibration materials) used in conjunction with diagnostic assays.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis. This in vitro diagnostic device is intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
JFM
Device Description
The Total Bilirubin kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: BR8307
R1. Total Bilirubin R1 4 x 20 mL
R2. Total Bilirubin R2 4 x 8 mL
REAGENT COMPOSITION
R1. Total Bilirubin R1
Citrate buffer, pH2.9
Detergent
Antimicrobial
Initial Concentration of Solutions: 0.1 mol/L, 0.9%
R2. Total Bilirubin R2
Phosphate buffer, pH 7.0
Sodium Metavanadate
Initial Concentration of Solutions: 10 mmol/L, 4 mmol/L
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 unconjugated Bilirubin or diluted to achieve Total Bilirubin concentrations based on normal ranges 0.3 - 1.2 mg/dL. Testing was conducted for two reagent lots of Total Bilirubin, 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 initially with no further calibration required.
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. The linearity samples were prepared at 11 levels spanning from 0.21 mg/dL to approximately 26.3 mg/dL using low and high serum pools. Each level was run in replicates of five on two lots of Total Bilirubin reagent on one RX Daytona plus system. The linear regression correlation between observed and expected values was 0.9999. The reportable range is 0.21 – 26.3 mg/dL. The Rx Davtona Plus analyzer has an auto-dilution feature for samples >26.3 mg/dL.
d. Detection limit:
Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2. Limit of Blank (L.o.B.), Limit of Detection (L.o.D.) and Limit of Quantitation were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.
The Limit of Detection (LoD) for Total Bilirubin on the RX Daytona Plus is 0.08 mg/dL based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 0.06 mg/dL.
The Limit of Quantitation (LoQ) is 0.21 mg/dL.
e. Analytical Specificity:
Interference studies have been carried out in accordance with C.L.S.I. guideline EP7-A2. Effects of potential interferents (Haemoglobin, Triglycerides, Intralipid®, Ascorbic Acid) were determined. Acceptance Criteria: No significant interference is recovery within ±10% of the initial value of Total Bilirubin concentration of 0.99 mg/dL and 15.03 mg/dL.
Haemoglobin: No significant interference up to 1000mg/dL
Triglycerides: No significant interference up to 2000mg/dL
Intralipid®: No significant interference up to 1000mg/dL
Ascorbic Acid: No significant interference up to 25.0mg/dL
f. Method comparison with predicate device:
Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2. 106 serum patient samples spanning the range 0.21 to 26.9 mg/dL were tested by two operators on two lots of Total Bilirubin reagent on one RX Daytona plus analyzer and the predicate device (ADVIA 1650 system) across 3 working days with each sample tested in singlicate. The linear regression equation was Y = 1.02x - 0.02 with a correlation coefficient of r = 0.9999.
q. Matrix comparison:
Matrix method comparisons for Total Bilirubin assay were tested by one operator on one RX Daytona plus system for two lots of reagents. Both serum and lithium heparin plasma were tested.
A minimum of 40 matched patient sample pairs (serum (x) and lithium heparin plasma (y)) were analyzed spanning the 0.23 to 23.5 mg/dL. The linear regression equation obtained was Y = 0.99x + 0.04 with a correlation coefficient of r = 0.9999.
Expected values/Reference range:
A reference interval for Total Bilirubin was verified using NCCLS C28-A3 guidelines. 30 normal donors' human serum samples were tested in singlicate on the RX daytona plus. The results obtained were ordered from lowest to highest before being examined for outliers using the Dixon test. Results indicate all values reported in the range for Healthy Individuals. Expected Values: 0.3 – 1.2 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with the outer profile forming the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG, QA/RA MANAGER 55 DIAMOND ROAD, ARDMORE CRUMLIN, COUNTY ANTRIM BT29 4OY, GREAT BRITAIN
January 28, 2016
Re: K152344
Trade/Device Name: Total Bilirubin (T BIL) Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: II Product Code: JFM Dated: December 15, 2015 Received: December 17, 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.
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/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.
Katherine Serrano -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
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Indications for Use
510(k) Number (if known) K152344
Device Name Total Bilirubin (TBIL)
Indications for Use (Describe)
For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis.
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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510(K) SUMMARY, TOTAL BILIRUBIN 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.
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: December 7, 2015
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K152344
Device Proprietary Name: Total Bilirubin (T BIL)
Common Name: Total Bilirubin
Purpose for Submission: New Device
| Product
| Code | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| JFM | Bilirubin (Total or | |||
| Direct) Test System | Class II | 21 CFR 862.1110 | Clinical | |
| Chemistry | ||||
| (75) |
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Siemens Healthcare Diagnostic Inc (formerly Bayer Healthcare), Total Bilirubin 2 reagent
510 (k) Number: K063845
5. INTENDED USE
For the quantitative in vitro determination of Total Bilirubin in serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis.
This in vitro diagnostic device is intended for prescription use only.
6. DEVICE DESCRIPTION
The Total Bilirubin kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: BR8307
| R1. Total Bilirubin R1 | 4 x 20 mL |
|---|---|
| R2. Total Bilirubin R2 | 4 x 8 mL |
REAGENT COMPOSITION
| Contents | Initial Concentration
of Solutions |
|-------------------------------------------------------------------------------|---------------------------------------|
| R1. Total Bilirubin R1
Citrate buffer, pH2.9
Detergent
Antimicrobial | 0.1 mol/L
0.9% |
| R2. Total Bilirubin R2
Phosphate buffer, pH 7.0
Sodium Metavanadate | 10 mmol/L
4 mmol/L |
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 Total Bilirubin test system for the RX Daytona plus to predicate device
| CHARACTERISTICS | Total Bilirubin Assay for
RX daytona plus (New
Device) | Siemens Healthcare Diagnostic Inc,
Total Bilirubin_2 reagent
(K063845)
(Predicate Device) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Similarities | |
| INTENDED USE | For the quantitative in vitro determination of
Total Bilirubin in serum and plasma. Total
Bilirubin measurements are used in the
diagnosis and treatment of hemolytic, biliary
and liver disorders, including hepatitis and
cirrhosis. | Same |
| ASSAY PROTOCOL | Vanadate Oxidation Method | Same |
| CONTROL
FREQUENCY | Randox assayed human multisera Level 2 & 3
Two levels of control should be assayed at
least once a day | Same |
| SAMPLE TYPE | Serum, heparinized plasma samples are
suitable. | Same |
| REAGENT
COMPOSITION | Contents
Initial Concentration
of Solutions
R1.
Total Bilirubin R1
Citrate buffer, pH2.9
Detergent
Antimicrobial
R2.
Total Bilirubin R2
Phosphate buffer, pH 7.0
Sodium Metavanadate | Same |
| Differences | ||
|---|---|---|
| TEST RANGE | 0.21 - 26.3 mg/dL | 0.1 - 35 mg/dL |
| STORAGE | ||
| (UNOPENED) | Reagents are stable up to the expiry date | |
| when stored unopened at +2 to +8°C | Reagents are stable up to the expiry date | |
| when stored unopened at +2 to +35°C | ||
| CALIBRATION | ||
| FREQUENCY | Every 28 days, with a change of reagent lot | |
| or as indicated by quality control | ||
| procedures. | Every 60 days. |
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8. TEST PRINCIPLE (1)
The bilirubin is oxidised by vanadate at about pH 2.9 to produce biliverdin. In the presence of detergent and vanadate, both coniugate (direct) and unconiuqated bilirubin are oxidised. This oxidation reaction causes a decrease in the optical density of the yellow colour, which is specific to bilirubin. The decrease in optical density at 450/546 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.
Bilirubin + Surfactant + VO3- Biliverdin
- I . Tokuda K, Tanimoto K. New method of measuring serum bilirubin using vanadic acid. |pn | Clin Chem. 1993:22:116-122.2.
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 unconjugated Bilirubin or diluted to achieve Total Bilirubin concentrations based on normal ranges 0.3 - 1.2 mg/dL. Testing was conducted for two reagent lots of Total Bilirubin, 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 initially with no further calibration required. The results are summarized in the following tables.
| Lot 2 | MEAN | Within Run | Among Run | Among Day | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Method | Product | N | (mg/dl) | SD | CV | SD | CV | SD | CV | SD | CV |
| TBIL | LIN Pool | 80 | 25.0 | 0.23 | 0.9 | 0.14 | 0.6 | 0.32 | 1.3 | 0.41 | 1.7 |
| TBIL | LOQ Pool | 80 | 0.3 | 0.02 | 6.9 | 0.01 | 2.6 | 0.00 | 0.0 | 0.02 | 7.4 |
| TBIL | QC 1 | 80 | 1.5 | 0.04 | 2.9 | 0.02 | 1.6 | 0.01 | 0.7 | 0.05 | 3.4 |
| TBIL | QC 2 | 80 | 5.3 | 0.08 | 1.5 | 0.03 | 0.5 | 0.13 | 2.5 | 0.16 | 3.0 |
| TBIL | Serum Pool 1 | 80 | 1.1 | 0.05 | 4.0 | 0.03 | 2.4 | 0.03 | 2.8 | 0.06 | 5.4 |
| TBIL | Serum Pool 2 | 80 | 6.7 | 0.11 | 1.6 | 0.08 | 1.1 | 0.09 | 1.4 | 0.16 | 2.4 |
| TBIL | Serum Pool 3 | 80 | 12.0 | 0.12 | 1.0 | 0.07 | 0.6 | 0.24 | 2.0 | 0.28 | 2.3 |
| TBIL | Serum Pool 4 | 80 | 16.2 | 0.15 | 0.9 | 0.21 | 1.3 | 0.24 | 1.5 | 0.35 | 2.2 |
Table 2 Precision Summary
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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. The sponsor set a range from 0.21 mg/dl analyte concentration up to a high concentration approximately 26.3 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 Total Bilirubin reagent on one RX Daytona plus 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 | Total Bilirubin
(mg/dL) |
|-------------------|----------------------------|
| Linear Regression | $Y = 1.02 + 0.01$ |
| r | 0.9999 |
| Analyte | Linearity | Reportable Range |
|---|---|---|
| TBIL | 26.3 mg/dl | 0.21 – 26.3 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. The Rx Davtona Plus analyzer has an auto-dilution feature that is automatically activated when measuring samples >26.3 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 K942458 Randox Assayed Multisera Level 2 and Level 3.
Refer to K053153 Randox Calibration Serum Level 3.
Randox Calibration Serum Level 3 for Total Bilirubin is traceable to an internal master reference material.
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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 Total Bilirubin on the RX Daytona Plus is 0.08 mg/dL based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 0.06 mg/dL.
The Limit of Quantitation (LoQ) is 0.21 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 Total Bilirubin concentration of 0.99 mg/dL and 15.03 mg/dL
| Haemoglobin | No significant interference up to 1000mg/dL |
|---|---|
| Triglycerides | No significant interference up to 2000mg/dL |
| Intralipid® | No significant interference up to 1000mg/dL |
| Ascorbic Acid | No significant interference up to 25.0mg/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'.
106 serum patient samples spanning the range 0.21 to 26.9 mg/dL were tested by two operators on two lots of Total Bilirubin reagent on one RX Daytona plus analyzer and the predicate device tested on one ADVIA 1650 system across 3 working days with each sample tested in singlicate.
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The test method was compared to the predicate device and the following linear regression equation was obtained:
Y = 1.02x - 0.02 Correlation coefficient of r = 0.9999
q. Matrix comparison:
Matrix method comparisons for Total Bilirubin assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of 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.
Total Bilirubin 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 40 matched patient sample pairs were analyzed spanning the 0.23 to 23.5 mg/dl and the following linear regression equation was obtained:
Y = 0.99x + 0.04
Correlation coefficient of r = 0.9999
Expected values/Reference range:
Referenced from literature
A reference interval for Total Bilirubin was verified using NCCLS C28-A3 guidelines. In a study, human serum from 30 normal donors were tested in singlicate on the RX daytona plus. The results obtained were ordered from lowest to highest before being examined for outliers using the Dixon test.
Upon confirmation there were no outliers; the values were compared to the quoted ranges for Total Bilirubin. Results of the study indicate that all values reported in the range for Healthy Individuals.
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Table 4 Reference Ranges
| Analyte | Expected Values |
|---|---|
| Total Bilirubin (2) | 0.3 – 1.2 mg/dL |
- WuAHB. Tietz Clinical Guide to laboratory Tests, 4th edition, Saunders Elsevier, St. Louis, MO: 2006:316.
10. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.