(34 days)
Not Found
No
The device description and performance studies focus on standard chemical assay principles and statistical analysis of quantitative results, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) test used for the quantitative measurement of total bilirubin, aiding in the diagnosis and treatment of conditions, rather than directly providing therapy.
Yes
The device aids in the diagnosis and treatment of various disorders, including liver, hematological, and metabolic disorders, and helps indicate the risk of bilirubin encephalopathy in neonates.
No
The device is a reagent kit used on a specific hardware system (ARCHITECT c8000 System) for a chemical assay. It involves physical reagents and a measurement process, not solely software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is used for the "quantitation of total bilirubin in human serum or plasma" and that the measurement is used in the "diagnosis and treatment of liver, hematological and metabolic disorders." This clearly indicates the device is intended for use in vitro (outside the body) to examine specimens derived from the human body for the purpose of providing information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details the reagents used and the principle of the procedure, which involves a chemical reaction with a human specimen (serum or plasma) to measure an analyte (bilirubin). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes various performance studies conducted using human specimens (serum and plasma) to evaluate the device's analytical performance (LOB, LOD, LOQ, Linearity, Precision, Interference, Method Comparison, Reference Range, etc.). These types of studies are standard for IVD devices to demonstrate their accuracy and reliability for clinical use.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K121985) and the name "Total Bilirubin" strongly suggests that this device is being compared to a previously cleared IVD device, which is a common pathway for regulatory clearance of new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT c8000 System.
Measurement of total bilirubin, an organic compound formed during the normal destruction of red blood cells, is used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Product codes (comma separated list FDA assigned to the subject device)
CIG, MQM
Device Description
The Total Bilirubin reagent kit contains Reagent 1 (R1) and Reagent 2 (R2). Reagent 1 is composed of Surfactants (10.57%) and HCl (6.563 g/L). Reagent 2 is composed of 2, 4-dichloroaniline (0.81 g/L), HCl (5.563 g/L), Sodium nitrite (0.345 g/L), and Surfactant (1.96%). The kit comes in two sizes: 7P32-21 with 10 x 53 mL of R1 and 10 x 17 mL of R2, estimated for 2750 tests; and 7P32-41 with 8 x 93 mL of R1 and 8 x 28 mL of R2, estimated for 3840 tests.
Principles of the Procedure: Total (conjugated and unconjugated) bilirubin couples with a diazo reagent in the presence of a surfactant to form azobilirubin. The diazo reaction is accelerated by the addition of surfactant as a solubilizing agent. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration. The detection of analyte is via end-point colorimetric method.
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
Adults and neonates
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
Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOQ):
Study was performed based on guidance from CLSI document EP17-A2.
- LoB: Determined using 4 samples prepared with human serum albumin (zero-analyte samples). Tested in a minimum of 5 replicates on 5 separate runs.
- LoD and LoQ: Determined using low-level analyte samples prepared from human serum albumin and unconjugated bilirubin. A minimum of 2 low-analyte level samples were gravimetrically prepared at each of the following 8 target concentration levels: 0.010, 0.020, 0.040, 0.080, 0.150, 0.300, 0.450, and 0.600 mg/dL. Tested in a minimum of 10 replicates on 5 separate runs.
Testing was performed over a minimum of 3 days using 2 lots of reagent, 2 lots of commercially available calibrators, and 1 lot of commercially available controls on 3 ARCHITECT c8000 instruments. Each reagent lot was matched with a different lot of calibrator.
Linearity:
Study was performed based on guidance from NCCLS document EP6-A.
- Three combined bilirubin pools were prepared:
- Pool 1: 75% conjugated bilirubin stock / 25% unconjugated bilirubin stock
- Pool 2: 50% conjugated bilirubin stock / 50% unconjugated bilirubin stock
- Pool 3: 25% conjugated bilirubin stock / 75% unconjugated bilirubin stock
- A sample set was prepared for each combined bilirubin pool. Each sample set consisted of 12 levels at the following total bilirubin target concentrations: 0.0 (serum), 0.1, 0.5, 2.0, 4.0, 8.0, 12.0, 16.0, 20.0, 22.0, 25.0, and 28.0 mg/dL.
- Levels 1 through 12 for each sample set were tested in a random order in a minimum of 4 replicates using 2 lots reagents and 1 lot each of commercially available calibrators and controls on 1 ARCHITECT c8000 instrument. All levels in a sample set were tested in the same run.
Within-Laboratory Precision (20-Day):
Precision was evaluated using the following Bio-Rad serum based control materials: Level 1 (Bio-Rad Lyphochek Unassayed Chemistry Control Level 1), Level 2 (Bio-Rad Lyphochek Unassayed Chemistry Control Level 2), Level 3 (Bio-Rad Liquichek Pediatric Control Level 1), Level 4 (Bio-Rad Liquichek Pediatric Control Level 2).
- The levels were tested in a minimum of 2 replicates 2 times per day (separated by a minimum of 2 hours) for a total of 20 testing days.
- Testing was performed using 2 lots of reagents and commercially available calibrators and 1 lot of commercially available controls on 2 ARCHITECT c8000 instruments. During each run, a given reagent lot/calibrator lot combination was randomly tested.
- Analysis was performed based on guidance from NCCLS document EP5-A2.
Interference:
The interference study was performed based on guidance from CLSI document EP7-A2.
- Interference effects were assessed by dose response and paired difference methods at two total bilirubin concentrations (1.2 mg/dL and 13.4 mg/dL/14.7 mg/dL depending on interferent). An additional interferent test was conducted at 1.0 mg/dL.
Method Comparison:
The study was performed based on guidance from CLSI document EP09-A2-IR.
- A total of 124 adult patient specimens and 64 neonatal patient specimens were evaluated with the candidate Total Bilirubin assay and the predicate Total Bilirubin (K121985) assay.
- A total of 4 adult and 4 neonate patient samples were spiked.
- Each sample was tested using 2 lots each of the candidate Total Bilirubin assay and the predicate Total Bilirubin (K121985) reagents and 1 lot each of commercially available calibrators and controls.
- Testing was performed in duplicate on the candidate Total Bilirubin assay and in duplicate on the predicate Total Bilirubin assay over 5 separate days on 1 ARCHITECT c8000 System.
Reference Range:
The study was performed based on guidance from CLSI document EP28-A3c.
- Fresh, adult patient serum samples from a clinically healthy population of non-distinguished adult male and female patients were obtained.
- The samples were stored at 2 to 8 degrees C and protected from light when not in use. The samples were up to 3 days old when received at the testing site. The samples were tested on the day they were received at the testing site.
- The samples were tested in a replicate of 1 using 1 lot of reagents and 1 lot each of commercially available calibrators and controls on 1 ARCHITECT c8000 instrument. A total of 40 samples (10%) were evaluated.
Automated Dilution Protocol versus Manual Dilution Procedure:
- Fresh serum specimens were obtained and, if necessary, pooled to create test samples at the following target total bilirubin concentrations: 34, 32, 30, 28, 26, and 24 mg/dL.
- The samples were divided into 3 portions. One portion of each sample was tested using the 1:5 and 1:10 autodilution protocols. Two portions were manually diluted using 0.85% saline solution, one at 1:5 and the other at 1:10.
- All portions were tested in replicates of 6 in the same run as the autodiluted samples using 1 lot of reagents on one ARCHITECT c8000 System.
Specimen Tube Type (Matrix Equivalence):
The study was performed based on guidance from CLSI document EP9-A3 and CLSI document GP34-A.
- The study control tube type was the serum plastic tube.
- The following tubes types were under evaluation: serum with gel separator, K2 EDTA plasma (without gel separator), lithium heparin plasma (without gel separator), lithium heparin plasma with gel separator, and sodium heparin plasma (without gel separator).
- Fresh or frozen sample sets were obtained that included the control tube type and at least 1 tube type under evaluation.
- Each tube type under evaluation was assessed using a minimum of 40 samples from adult subjects (actual N values: Serum (glass) 41, Serum Separator Tube (SST) 40, Ethylenediaminetetraacetic Acid (EDTA) 39, Lithium Heparin 40, Lithium Heparin Plasma Separator Tube (PST) 40, Sodium Heparin 39).
- The sample sets spanned the assay's measuring interval. All samples were tested in replicates of 6 using 1 lot each of reagents and commercially available calibrators and controls on 1 ARCHITECT c8000 System. All samples collected from the same subject were tested in the same run.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOQ):
- Standalone performance: The LoQ of the Total Bilirubin assay is 0.174 mg/dL. The LoQ supports the lower end of the measuring interval of 0.3 mg/dL. LoD is 0.174 mg/dL and LoB is 0.102 mg/dL.
Linearity:
- Standalone performance: The Total Bilirubin assay was demonstrated to be linear across the measuring interval of 0.3 to 25.0 mg/dL.
Within-Laboratory Precision (20-Day):
- Standalone performance:
- Sample 1 (mean 0.87 mg/dL / 14.90 µmol/L): Within Run SD 0.010 mg/dL (1.2%CV) / 0.17 µmol/L (1.2%CV); Total SD 0.018 mg/dL (2.1%CV) / 0.31 µmol/L (2.1%CV).
- Sample 2 (mean 4.53 mg/dL / 77.57 µmol/L): Within Run SD 0.034 mg/dL (0.8%CV) / 0.58 µmol/L (0.8%CV); Total SD 0.057 mg/dL (1.3%CV) / 0.97 µmol/L (1.3%CV).
- Sample 3 (mean 6.42 mg/dL / 109.93 µmol/L): Within Run SD 0.041 mg/dL (0.6%CV) / 0.70 µmol/L (0.6%CV); Total SD 0.066 mg/dL (1.0%CV) / 1.13 µmol/L (1.0%CV).
- Sample 4 (mean 16.85 mg/dL): Within Run SD 0.115 mg/dL (0.7%CV); Total SD 0.204 mg/dL (1.2%CV).
Interference:
- Key results: Indican, at concentrations > 0.125 mmol/L, interferes with the assay in samples with bilirubin levels at 1.2 mg/dL.
- Hemoglobin (2000 mg/dL or 20 g/L):
- At bilirubin 1.0 mg/dL (17.1 µmol/L): Observed Diff -0.1 mg/dL (-1.7 µmol/L), -9.8%.
- At bilirubin 13.4 mg/dL (229.1 µmol/L): Observed Diff -0.4 mg/dL (-6.8 µmol/L), -3.0%.
- Intralipid (1000 mg/dL or 10 g/L):
- At bilirubin 1.0 mg/dL (17.1 µmol/L): Observed Diff 0.0 mg/dL (0.0 µmol/L), -0.6%.
- At bilirubin 13.4 mg/dL (229.1 µmol/L): Observed Diff -0.1 mg/dL (-1.7 µmol/L), -0.6%.
- Indican:
- At 0.125 mmol/L and bilirubin 0.9 mg/dL (15.4 µmol/L): Observed Diff 0.2 mg/dL (3.4 µmol/L), 26.7%.
- At 0.25 mmol/L and bilirubin 14.7 mg/dL: Observed Diff 0.5 mg/dL, 3.2%.
- Hemoglobin (2000 mg/dL or 20 g/L):
Method Comparison (Passing-Bablok regression results based on singlet test results from a representative reagent lot):
- Adult Population (N=118): Slope 0.99, Intercept -0.09, Correlation Coefficient 0.9994. Range: 0.3 to 24.8 mg/dL.
- Neonate Population (N=54): Slope 0.96, Intercept 0.01, Correlation Coefficient 0.9982. Range: 0.3 to 24.3 mg/dL.
Reference Range:
- Standalone performance: The reference range was determined to be 0.3 mg/dL to 1.2 mg/dL.
- Key results: 4 of 40 samples (10%) were outside the reference range (all out-of-range samples were
§ 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other.
April 2, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ABBOTT LABORATORIES SUSHMA RAO REGULATORY AFFAIRS PROJECT MANAGER 1921 HURD DRIVE IRVING TX 75038
Re: K150510
Trade/Device Name: Total Bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: II Product Code: CIG, MOM Dated: March 2, 2015 Received: March 3, 2015
Dear Sushma Rao:
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,
Stayce Beck -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) K150510
Device Name Total Bilirubin
Indications for Use (Describe)
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT c8000 System.
Measurement of total bilirubin, an organic compound formed during the normal destruction of red blood cells, is used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
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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K150510
510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Applicant Name
Sushma Rao, ADD, Regulatory Affairs Project Manager Abbott Laboratories 1921 Hurd Drive Irving, TX 75038 (972) 518-7081 Fax: (972) 518-6960 Email: sushma.rao@abbott.com
Date Summary prepared: April 2, 2015
2. Device Name
Trade Name: Total Bilirubin Device Classification: Class II
Classification Name: Total Bilirubin Reagent Governing Regulation: CFR 862.1110 Product Code: CIG
Classification Name: Bilirubin (total and unbound) in the neonate test system Governing Regulation: 862.1113 Product Code: MQM
3. Predicate Device
Total Bilirubin, K121985
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4. Description of Device
The Total Bilirubin reagent kit contains:
| Number of Bottles × Volume | ||
|---|---|---|
| Component | 7P32-21 | 7P32-41 |
| Reagent 1 (R1) | $10 \times 53$ mL | $8 \times 93$ mL |
| Reagent 2 (R2) | $10 \times 17$ mL | $8 \times 28$ mL |
| Estimated tests per kit* | 2750 | 3840 |
Calculation is based on the minimum reagent fill volume per kit. 米
| Reagent | Reactive Ingredients | Concentration |
|---|---|---|
| Reagent 1 | Surfactants | 10.57% |
| Reagent 1 | HCl | 6.563 g/L |
| Reagent 2 | 2, 4-dichloroaniline | 0.81 g/L |
| Reagent 2 | HCl | 5.563 g/L |
| Reagent 2 | Sodium nitrite | 0.345 g/L |
| Reagent 2 | Surfactant | 1.96% |
Principles of the Procedure
Total (conjugated and unconjugated) bilirubin couples with a diazo reagent in the presence of a surfactant to form azobilirubin. The diazo reaction is accelerated by the addition of surfactant as a solubilizing agent. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration.
5. Indication for Use
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT c8000 System.
Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. A bilirubin (total and unbound) in the neonate test system is a device intended to
5
measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
6. Comparison of Technological Characteristics
The Total Bilirubin assay is used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT c 8000 System.
A comparison of the candidate assay (Total Bilirubin) and the predicate assay (K121985) is presented in the table below.
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Comparison of Total Bilirubin to Predicate Total Bilirubin Assay on the ARCHITECT c8000 Analyzer
| Assay
Characteristics | Total Bilirubin | | Predicate Total Bilirubin
Assay (K121985 ) on the
ARCHITECT c8000 System | | |
|--------------------------|------------------------------------------|---------------|--------------------------------------------------------------------------------|-----------|--|
| Intended Use | The Total Bilirubin assay is used for | | Same | | |
| | the quantitative analysis of total | | | | |
| | bilirubin in human serum or plasma of | | | | |
| | adults and neonates on the | | | | |
| | ARCHITECT c 8000 System. | | | | |
| Assay Principle | Total (conjugated and unconjugated) | | Same | | |
| | bilirubin couples with a diazo reagent | | | | |
| | in the presence of a surfactant to form | | | | |
| | azobilirubin. The diazo reaction is | | | | |
| | accelerated by the addition of | | | | |
| | surfactant as a solubilizing agent. The | | | | |
| | increase in absorbance at 548 nm due | | | | |
| | to azobilirubin is directly proportional | | | | |
| | to the total bilirubin concentration. | | | | |
| Detection of | End-point colorimetric | | Same | | |
| Analyte | | | | | |
| Samples | Serum or plasma | | Same | | |
| Assay Range | 0.3 to 25.0 mg/dL | | 0.1 to 25.0 mg/dL | | |
| Reference Range - | | Range (mg/dL) | Same | | |
| Newborn | Premature Newborn | | | | |
| | 10%, or > 0.2 mg/dL (> 3.4 umol/L) for bilirubin concentrations ≤ 2.0 mg/dL is considered significant interference.
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| Interferent | Bilirubin | |||
|---|---|---|---|---|
| Interfering | ||||
| Substance | Interferent | |||
| Concentration | Control | |||
| (mg/dL) | Observed Diff | |||
| (mg/dL) | (%) | |||
| Hemoglobin | 2000 mg/dL | 1.0 | -0.1 | -9.8 |
| Hemoglobin | 2000 mg/dL | 13.4 | -0.4 | -3.0 |
| Intralipid | 1000 mg/dL | 1.0 | 0.0 | -0.6 |
| Intralipid | 1000 mg/dL | 13.4 | -0.1 | -0.6 |
| Indican | 0.125 mmol/L | 0.9 | 0.2 | 26.7 |
| Indican | 0.25 mmol/L | 14.7 | 0.5 | 3.2 |
| Interferent | Bilirubin | |||
| Interfering | ||||
| Substance | Interferent | |||
| Concentration | Control | |||
| (µmol/L) | Observed Diff | |||
| (µmol/L) | (%) | |||
| Hemoglobin | 20 g/L | 17.1 | -1.7 | -9.8 |
| Hemoglobin | 20 g/L | 229.1 | -6.8 | -3.0 |
| Intralipid | 10 g/L | 17.1 | 0.0 | -0.6 |
| Intralipid | 10 g/L | 229.1 | -1.7 | -0.6 |
| Indican | 0.125 mmol/L | 15.4 | 3.4 | 26.7 |
Results Tables: (Conventional and International Units)
Indican, at concentrations > 0.125 mmol/L, interferes with the assay in samples with bilirubin levels at 1.2 mg/dL.
Method Comparison
The study was performed based on guidance from CLSI document EP09-A2-IR. A total of 124 adult patient specimens and 64 neonatal patient specimens were evaluated with the candidate Total Bilirubin assay and the predicate Total Bilirubin (K121985) assay. A total of 4 adult and 4 neonate patient samples were spiked. Each sample was tested using 2 lots each of the candidate Total Bilirubin assay and the predicate Total Bilirubin (K121985) reagents and 1 lot each of commercially available calibrators and controls. Testing was performed in duplicate on the candidate Total Bilirubin assay and in duplicate on the predicate Total Bilirubin assay over 5 separate days on 1 ARCHITECT c 8000 System. Passing-Bablok regression results based on singlet test results from a representative reagent lot are summarized below:
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Adult Population Representative Data
| N | Slope | Intercept | Correlation
Coefficient | Range
(mg/dL) |
|-----|-------|-----------|----------------------------|------------------|
| 118 | 0.99 | -0.09 | 0.9994 | 0.3 to 24.8 |
Neonate Population Representative Data
| N | Slope | Intercept | Correlation
Coefficient | Range
(mg/dL) |
|----|-------|-----------|----------------------------|------------------|
| 54 | 0.96 | 0.01 | 0.9982 | 0.3 to 24.3 |
Reference Range
The study was performed based on guidance from CLSI document EP28-A3c. Fresh, adult patient serum samples from a clinically healthy population of non-distinguished adult male and female patients were obtained. The samples were stored at 2 to 8℃ and protected from light when not in use. The samples were up to 3 days old when received at the testing site. The samples were tested on the day they were received at the testing site. The samples were tested in a replicate of 1 using 1 lot of reagents and 1 lot each of commercially available calibrators and controls on 1 ARCHITECT c 8000 instrument.
The Total Bilirubin assay, which had a total of 4 of 40 samples (10%) outside the reference range (all out-of-range samples were