(59 days)
No
The device description and performance studies focus on chemical reagents and analytical measurements, with no mention of AI/ML terms or methodologies.
No.
This device is for in vitro diagnostic use to measure total bilirubin, which is used for diagnosis and treatment of conditions, not for therapy itself.
Yes
Explanation: The "Intended Use" section explicitly states that the device is "For in vitro diagnostic use in the quantitative determination of total bilirubin in serum and plasma... used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders." This directly indicates its purpose as a diagnostic tool.
No
The device description clearly states it is a reagent kit consisting of liquid reagents packaged in wedges, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Sample Type: It is designed to test "serum and plasma", which are biological samples taken from the body.
- Purpose: The purpose is to "quantitatively determine total bilirubin", which is a measurement used in the "diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders". This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use in the quantitative determination of total bilirubin in serum and plasma of adults and neonates on the ADVIA® Chemistry systems. Measurement of total bilirubin, an organic compound formed 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 total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Product codes (comma separated list FDA assigned to the subject device)
JFM, MQM
Device Description
The ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) reagents are liquid ready to use. They are packaged as a kit with two kit sizes available as follows.
Kit Size – 70 mL Wedge Reagent 1 and 70 mL Reagent 2 Wedge
Reagent 1: 4 wedges x 68 mL
Reagent 2: 4 wedges x 25 mL
Kit Size - 40 mL Reagent 1 and 20 mL Reagent 2 Wedge
Reagent 1: 4 wedges x 38 mL
Each reagent kit consists of reagents of components and concentrations summarized below.
Reagent 1: Citrate buffer, pH 2.9 (0.1 mol/L), Detergent
Reagent 2: Phosphate buffer, pH 7.0 (10mmol/L), Sodium metavanadate (4 mmol/L)
Assay Principle: The ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) method is based on a chemical oxidation method using vanadate as an oxidizing agent. The bilirubin is oxidized by vanadate at about pH 2.9 to produce biliverdin. In the presence of the detergent and the vanadate, both conjugated (direct) and unconjugated bilirubin are oxidized. This oxidation reaction causes the decrease in the optical density of the yellow color. which is specific to bilirubin. The decrease in optical density at 451/545 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.
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
Licensed healthcare professional
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Method Comparison: A method comparison study was performed to demonstrate the accuracy of the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) on the ADVIA® Chemistry 1800 System following CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Approved Guideline, Third Edition.
N: 119
Range: 0.7 – 31.6 (ADVIA®), 0.8 – 26.6 mg/dL (Comparator Method)
Slope: 1.06
y-intercept: -0.24
Correlation coefficient (r): 0.990
Medical decision point concentration (bias): 1.0 mg/dL (-0.2 mg/dL), 13.0 mg/dL (0.5 mg/dL), and 17.0 mg/dL (0.8 mg/dL).
b. Analytical Measuring Range/Linearity: Linearity was evaluated on the ADVIA® Chemistry 1800 System to determine the upper limit of the assay range according to CLSI EP06-A: Evaluation of the Linearity of Quantitative Analytical Measurement Procedure: A Statistical Approach, Approved Guideline.
Slope: 0.999
y- intercept: 0.016
r: 0.999
Number of Levels: 9
Observed Sample Range (mg/dL): 0.0-39.2
Analytical Measuring Range (mg/dL): 0.15-35.0
c. Limits of Detection and Quantitation: Limits of Blank (LoB) and Limit of Detection (LoD) were determined experimentally on the ADVIA® Chemistry 1800 System following CLSI EP 17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline; Second Edition.
Limit of Blank (LoB): 0.02 mg/mL
Limit of Detection (LoD): 0.06 mg/dL
Limit of Quantitation (LoQ): 0.08 mg/dL
d. Interferences: Interference testing was evaluated ADVIA® Chemistry 1800 System according to CLSI EP07-A2 Interference Testing in Clinical Chemistry, Approved Guideline, Second Edition. Neonatal specific interferences were tested in a sample with low and high concentration of bilirubin.
Interferents tested were acceptable with ≤10% bias or recovery of interferent to blank within ±10%.
Indican: 10 mg/dL
Cyanokit: 40 ug/mL
HbF: 1000 mg/dL
HbA: 1000 mg/dL
e. Expected Values (Reference Interval): The reference interval for the ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) is outlined in the literature reference: Wu AHB. Tietz Clinical Guide to Laboratory Tests, 4th edition, Saunders Elsevier, St. Louis, MO: 2006:172. The expected values were verified in accordance with CLSI EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, Approved Guideline, Third Edition; October 19, 2010.
Age: 0-1 day - 5 days – 60 years - 0.3-1.2 mg/dL
Age: 60 - 90 years - 0.2-1.1 mg/dL
Age: >90 years - 0.2-0.9 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
SIEMENS HEALTHCARE DIAGNOSTICS, INC. JULIE WARREN REGULATORY TECHNICAL SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K170065
Trade/Device Name: ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: II Product Code: JFM, MOM Dated: January 6, 2017 Received: January 9, 2017
Dear Julie Warren:
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,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170065
Device Name
ADVIA® Chemistry Total Bilirubin 2 (TBIL 2)
Indications for Use (Describe)
For in vitro diagnostic use in the quantitative determination of total bilirubin in serum and plasma of adults and neonates on the ADVIA® Chemistry systems. Measurement of total bilirubin, an organic compound formed 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 total bilirubin measurement in newborn infants is intended 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) |
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 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
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K170065
1. Submitter
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 USA Establishment Registration Number: 2432235 Contact Person: Julie Warren Tel: 302-631-8722 Fax: 302-631-6299 Email: julie.warren@siemens.com
Date of Preparation: March 8, 2017
2. Device Information
Federal (USA) law restricts this device to sale by or on the order of a licensed healthcare professional. For in vitro diagnostic use.
| Name of Device: | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) |
|---|---|
| Common Name: | TBIL_2 |
| Regulation Description: | Bilirubin (total or direct) test system; |
| Bilirubin (total and unbound) in the neonate system | |
| Regulation Section: | 21 CFR §862.1110; |
| 21 CFR §862.1113 | |
| Device Class: | Class II |
| Product Code: | JFM; |
| MQM | |
| Panel: | Clinical Chemistry |
3. Predicate Device
| Product Name: | Abbott Laboratories Total Bilirubin |
|---|---|
| 510(k) Clearance | K150510 |
| Regulation Description: | Bilirubin (total or direct) test system; |
| Bilirubin (total and unbound) in the neonate system | |
| Regulation Section: | 21 CFR §862.1110; |
| 21 CFR §862.1113 | |
| Device Class: | Class II |
| Product Code: | CIG; |
| MQM | |
| Panel: | Clinical Chemistry |
4
4. Device Description
The ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) reagents are liquid ready to use. They are packaged as a kit with two kit sizes available as follows.
| Kit Size – 70 mL Wedge Reagent 1 and 70 mL Reagent 2 Wedge | |
|---|---|
| Reagent 1 | 4 wedges x 68 mL |
| Reagent 2 | 4 wedges x 25 mL |
| Kit Size - 40 mL Reagent 1 and 20 mL Reagent 2 Wedge | |
| Reagent 1 | 4 wedges x 38 mL |
Each reagent kit consists of reagents of components and concentrations summarized below.
| Reagent | Component and Concentration |
|---|---|
| Reagent 1 | Citrate buffer, pH 2.9 (0.1 mol/L) |
| Detergent | |
| Reagent 2 | Phosphate buffer, pH 7.0 (10mmol/L) |
| Sodium metavanadate (4 mmol/L) |
Assay Principle
The ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) method is based on a chemical oxidation method using vanadate as an oxidizing agent. The bilirubin is oxidized by vanadate at about pH 2.9 to produce biliverdin. In the presence of the detergent and the vanadate, both conjugated (direct) and unconjugated bilirubin are oxidized. This oxidation reaction causes the decrease in the optical density of the vellow color. which is specific to bilirubin. The decrease in optical density at 451/545 nm is proportional to the total bilirubin concentration in the sample. The concentration is measured as an endpoint reaction.
Reaction Equation
Bilirubin + Surfactant + Biliverdin
5. Intended Use/Indications for Use
For in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA® Chemistry systems. 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 total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
5
6. Medical Device to Which Equivalence is Claimed
The Siemens Healthcare Diagnostics Inc. ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) and the Abbott Laboratories Total Bilirubin Assay are both in vitro diagnostic devices intended to be used in the quantitative determination of total bilirubin in human serum and plasma. The predicate and the proposed device support the use in quantitating total bilirubin in human serum and plasma in adults and neonates. The proposed device was compared side by side to the predicate device via the following table to examine their similarities and differences between the devices.
| Attribute | Predicate Device
Abbott Laboratories
(K150510) | Proposed Device
ADVIA® Chemistry
Total Bilirubin_2 (TBIL_2) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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
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). | For in vitro diagnostic use in the
quantitative determination of total
bilirubin in human serum and plasma
on the ADVIA® Chemistry systems.
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
total bilirubin measurement in
newborn infants is intended to aid in
indicating the risk of bilirubin
encephalopathy (kernicterus). |
| Measurand | Total Bilirubin | Same |
| Assay Principle | 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 | The bilirubin is oxidized by vanadate
at about pH 2.9 to produce biliverdin.
In the presence of the detergent and
the vanadate, both conjugated (direct)
and unconjugated bilirubin are
oxidized. This oxidation reaction
causes the decrease in the optical
density of the yellow color, which is
specific to bilirubin. The decrease in |
| Attribute | Predicate Device
Abbott Laboratories
(K150510) | Proposed Device
ADVIA® Chemistry
Total Bilirubin_2 (TBIL_2) |
| | directly proportional to the total
bilirubin concentration. | optical density at 451/545 nm is
proportional to the total bilirubin
concentration in the sample. |
| Measurement
Protocol | End-point colorimetric | End-point |
| Sample Types | Serum and plasma from adults
and neonates | Same |
| Reagent Form | Liquid, ready to use | Same |
| Reagent
Composition | R1:
Surfactants 10.57%
HCl 6.563 g/L
R2:
2,4-dichloroaniline 0.81 g/L
HCl 5.563 g/L
Sodium nitrite 0.345 g/L
Surfactant 1.96% | R1:
Citrate buffer, pH 2.9
(0.1 mol/L); Detergent
R2:
Phosphate buffer, pH 7.0
(10 mmol/L);
Sodium metavanadate
(4 mmol/L) |
| Measuring Range | 0.3 to 25.0 mg/dL | 0.15 mg/dL-35.0 mg/dL |
| Expected Values | Premature Newborn
5 days - 60 years: 0.3-1.2 mg/dL*
60 – 90 years: 0.2-1.1 mg/dL
90 years: 0.2-0.9 mg/dL
*Ages >5 days to 29 days to 60 years
are children and adults. |
| Instrument | ARCHITECT c8000 System | ADVIA® Chemistry 1800 System |
Substantial Equivalence Comparison of Technological Characteristics with the Predicate Device
6
7. Performance Characteristics
All studies used to support the use of the device on the adult population were previously cleared under 510(k), K063845. Claims which are being transferred from the previous submission were performed on the ADVIA® Chemistry 1650 System, and therefore were not repeated. The reagent formulation and method parameters remain the same.
7
a. Method Comparison
A method comparison study was performed to demonstrate the accuracy of the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) on the ADVIA® Chemistry 1800 System following CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Approved Guideline, Third Edition. The comparative method was a legally marketed comparator method with a linearity range of 0.146 - 35.1 mg/dL. Samples were tested across the assay range. Weighted Deming regression analysis was performed. Results are summarized below.
| Regression Summary | |
|---|---|
| N | 119 |
| Range | 0.7 – 31.6 (ADVIA®) |
| 0.8 – 26.6 mg/dL | |
| (Comparator Method) | |
| Slope | 1.06 |
| y-intercept | -0.24 |
| Correlation coefficient (r) | 0.990 |
In addition, the bias at the medical decision levels (MDL) for the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) were calculated using the regression equation y = 1.06x-0.24. Medical decision point concentration (bias) is as follows: 1.0 mg/dL (-0.2 mg/dL (0.2 mg/dL), 13.0 mg/dL (0.5 mg/dL), and 17.0 mg/dL (0.8 mg/dL).
- b. Analytical Measuring Range/Linearity
Linearity was evaluated on the ADVIA® Chemistry 1800 System to determine the upper limit of the assay range according to CLSI EP06-A: Evaluation of the Linearity of Quantitative Analytical Measurement Procedure: A Statistical Approach, Approved Guideline.
| Slope | y- intercept | r | Number of
Levels | Observed
Sample
Range
(mg/dL) | Analytical
Measuring
Range
(mg/dL) |
|-------|--------------|-------|---------------------|----------------------------------------|---------------------------------------------|
| 0.999 | 0.016 | 0.999 | 9 | 0.0-39.2 | 0.15-35.0 |
c. Limits of Detection and Quantitation
Limits of Blank (LoB) and Limit of Detection (LoD) were determined experimentally on the ADVIA® Chemistry 1800 System following CLSI EP 17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline; Second Edition. The limit of blank and limit of detection for the ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) is 0.02 mg/mL and 0.06 mg/dL, respectively.
8
Limit of Quantitation (LoQ) was determined experimentally following CLS/ EP05-A2 Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline; Second Edition. The limit of quantitation for the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) is 0.08 mg/dL.
- d. Interferences
Interference testing was evaluated ADVIA® Chemistry 1800 System according to CLSI EP07-A2 Interference Testing in Clinical Chemistry, Approved Guideline, Second Edition. Neonatal specific interferences were tested in a sample with low and high concentration of bilirubin. The following interferents tested were acceptable with ≤10% bias or recovery of interferent to blank within ±10%.
| Substance | Highest substance concentration
tested that did not show
significant interference |
|-----------|-----------------------------------------------------------------------------------------|
| Indican | 10 mg/dL |
| Cyanokit | 40 ug/mL |
| HbF | 1000 mg/dL |
| HbA | 1000 mg/dL |
- e. Expected Values (Reference Interval)
The reference interval for the ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) is outlined in the literature reference: Wu AHB. Tietz Clinical Guide to Laboratory Tests, 4th edition, Saunders Elsevier, St. Louis, MO: 2006:172.
The expected values were verified in accordance with CLSI EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, Approved Guideline, Third Edition; October 19, 2010. Expected value ranges for the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) are as follows.
| Age | Expected Values |
|---|---|
| 0-1 day | 5 days – 60 years |
| 60 - 90 years | 0.2-1.1 mg/dL |
| >90 years | 0.2-0.9 mg/dL |
9
8. Conclusion
The Siemens Healthcare Diagnostics Inc. ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) were previously cleared for the adult population under 510(k), K063845. Studies on adults were not repeated because the formulation and method parameters remain the same.
The ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) and the Abbott Laboratories Total Bilirubin Assay are both in vitro diagnostic devices intended to be used in the quantitative determination of total bilirubin in human serum and plasma in adults and neonates. Both assays are liquid and ready to use on automated systems. Siemens Healthcare Diagnostics Inc. claims substantial equivalence to the currently marketed Abbott Laboratories Total Bilirubin Assay (K150510).