(59 days)
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).
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)
Here's a breakdown of the acceptance criteria and study information for the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) device, based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" for each performance characteristic as a distinct set of pre-defined thresholds. Instead, it presents the results of validation studies for various parameters. However, we can infer the implicit "acceptance criteria" by looking at industry standards (like CLSI guidelines cited) and typical performance expectations for such devices. The "reported device performance" directly comes from the study results.
Note: For some parameters, the "acceptance criteria" are implied by the method and regulatory guidelines (e.g., CLSI EP09-A3 for method comparison, which focuses on demonstrating accuracy through strong correlation and acceptable bias at medical decision points).
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation (r value close to 1), low bias at medical decision levels, demonstrating accuracy compared to a legally marketed comparator. (Based on CLSI EP09-A3) | N: 119Range (ADVIA®): 0.7 – 31.6 mg/dLRange (Comparator): 0.8 – 26.6 mg/dLSlope: 1.06y-intercept: -0.24Correlation coefficient (r): 0.990Bias at MDLs: 1.0 mg/dL (-0.2 mg/dL), 13.0 mg/dL (0.5 mg/dL), 17.0 mg/dL (0.8 mg/dL) |
| Analytical Measuring Range/Linearity | Demonstrated linearity across the claimed measuring range, with a slope close to 1 and an r value close to 1. (Based on CLSI EP06-A) | Slope: 0.999y-intercept: 0.016r: 0.999Number of Levels: 9Observed Sample Range: 0.0-39.2 mg/dLAnalytical Measuring Range: 0.15-35.0 mg/dL |
| Limits of Detection and Quantitation | Documented LoB, LoD, and LoQ based on experimental determination following CLSI guidelines. (Based on CLSI EP17-A2 and EP05-A2) | LoB: 0.02 mg/mLLoD: 0.06 mg/dLLoQ: 0.08 mg/dL |
| Interferences | Bias or recovery of interferent to blank within ±10% for relevant substances. (Based on CLSI EP07-A2) | Acceptable with ≤10% bias or recovery for: - Indican: 10 mg/dL- Cyanokit: 40 ug/mL- HbF: 1000 mg/dL- HbA: 1000 mg/dL |
| Expected Values (Reference Interval) | Reference intervals established or verified in accordance with CLSI guidelines and supported by literature. (Based on CLSI EP28-A3c and Wu AHB. Tietz Clinical Guide) | Verified expected values: - 0-1 day: <8.0 mg/dL- 1-2 days: <12.0 mg/dL- 3-5 days: <16.0 mg/dL- >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 (Reference: Wu AHB. Tietz Clinical Guide to Laboratory Tests, 4th edition, 2006:172) |
Detailed Study Information:
The provided document describes analytical performance studies for the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) device. It is a standalone (algorithm only without human-in-the-loop performance) study, as it evaluates the analytical performance of a clinical chemistry assay, not a diagnostic imaging device with human interpretation.
-
Sample Size Used for the Test Set and Data Provenance:
- Method Comparison: N = 119 patient samples.
- Analytical Measuring Range/Linearity: The document states "9 levels" for linearity but does not specify the number of individual samples tested at each level or overall (implied to be an internally prepared linearity panel).
- Limits of Detection and Quantitation: Not explicitly stated for specific test sets, usually involves multiple replicates of blank and low-concentration samples.
- Interferences: Not explicitly stated for specific test sets; involved samples with low and high concentrations of bilirubin plus various interferents.
- Data Provenance: Not explicitly stated. These are typically laboratory-generated samples or de-identified patient samples obtained for research purposes within the testing laboratory's region. The adult population data were previously cleared under K063845, implying this testing focused on neonatal-specific aspects or reaffirming general performance on the new instrument.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For this type of in vitro diagnostic device, "ground truth" is established through well-characterized reference methods or highly accurate comparator devices/methods. There are no "experts" in the human interpretation sense (like radiologists) involved in establishing the ground truth for these analytical measurements.
- The "comparator method" for the method comparison study served as the reference for ground truth in that context. Its specifics (e.g., gold standard, reference material) are not detailed beyond being a "legally marketed comparator method."
-
Adjudication Method for the Test Set:
- Not applicable. This is an analytical performance study of a quantitative assay, not a study involving human readers' interpretations of images or clinical reports requiring adjudication.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This document describes the analytical performance of an in vitro diagnostic assay, which traditionally does not involve human readers interpreting "cases" in the way an imaging device might.
-
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The entire document details the analytical performance of the ADVIA® Chemistry Total Bilirubin 2 (TBIL 2) assay on an automated instrument (ADVIA® Chemistry 1800 System) without human interpretive input for the final result beyond loading samples and running the assay.
-
The Type of Ground Truth Used:
- For the Method Comparison study, the ground truth was established by a legally marketed comparator method.
- For Linearity, LoD/LoQ, and Interference studies, the ground truth involves carefully prepared samples (e.g., spiked samples, diluted samples, reference materials) with known concentrations or expected responses, tested against established analytical validation protocols.
- For Expected Values (Reference Interval), the ground truth was established by literature reference (Wu AHB. Tietz Clinical Guide to Laboratory Tests, 4th edition, 2006:172) and verified according to CLSI guidelines.
-
Sample Size for the Training Set:
- Not applicable. This document describes the validation of a finished assay and instrument system. Clinical chemistry assays are developed and optimized through iterative research and development, but there isn't a "training set" in the machine learning sense. The "reagent formulation and method parameters" (mentioned as remaining the same for adult claims from K063845) represent the output of prior development.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. As a traditional in vitro diagnostic assay, the concept of a "training set" and associated ground truth is not relevant in the machine learning context. The assay's performance is governed by its chemical reaction principle and instrument calibration/characteristics.
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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.
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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,
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
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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) |
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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 |
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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).
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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 DeviceAbbott Laboratories(K150510) | Proposed DeviceADVIA® ChemistryTotal Bilirubin_2 (TBIL_2) |
|---|---|---|
| Intended Use/Indications forUse | The Total Bilirubin assay is usedfor the quantitation of total bilirubinin human serum or plasma ofadults and neonates on theARCHITECT c8000 System.Measurement of total bilirubin, anorganic compound formed duringthe normal andabnormal destruction of red bloodcells, is used in the diagnosis andtreatment of liver, hemolytic,hematological and metabolicdisorders, including hepatitis andgall bladder block. A bilirubin (totaland unbound) in the neonate testsystem is a device intended tomeasure the levels of bilirubin(total and unbound) in the blood(serum) of newborn infants to aidin indicating the risk of bilirubinencephalopathy (kernicterus). | For in vitro diagnostic use in thequantitative determination of totalbilirubin in human serum and plasmaon the ADVIA® Chemistry systems.Measurement of total bilirubin, anorganic compound formed during thenormal and abnormal destruction ofred blood cells, is used in thediagnosis and treatment of liver,hemolytic hematological, andmetabolic disorders, includinghepatitis and gall bladder block. Atotal bilirubin measurement innewborn infants is intended to aid inindicating the risk of bilirubinencephalopathy (kernicterus). |
| Measurand | Total Bilirubin | Same |
| Assay Principle | Total (conjugated andunconjugated) bilirubin coupleswith a diazo reagent in thepresence of a surfactant to formazobilirubin. The diazo reaction isaccelerated by the addition ofsurfactant as a solubilizing agent.The increase in absorbance at548 nm due to azobilirubin is | The bilirubin is oxidized by vanadateat about pH 2.9 to produce biliverdin.In the presence of the detergent andthe vanadate, both conjugated (direct)and unconjugated bilirubin areoxidized. This oxidation reactioncauses the decrease in the opticaldensity of the yellow color, which isspecific to bilirubin. The decrease in |
| Attribute | Predicate DeviceAbbott Laboratories(K150510) | Proposed DeviceADVIA® ChemistryTotal Bilirubin_2 (TBIL_2) |
| directly proportional to the totalbilirubin concentration. | optical density at 451/545 nm isproportional to the total bilirubinconcentration in the sample. | |
| MeasurementProtocol | End-point colorimetric | End-point |
| Sample Types | Serum and plasma from adultsand neonates | Same |
| Reagent Form | Liquid, ready to use | Same |
| ReagentComposition | R1:Surfactants 10.57%HCl 6.563 g/LR2:2,4-dichloroaniline 0.81 g/LHCl 5.563 g/LSodium nitrite 0.345 g/LSurfactant 1.96% | R1:Citrate buffer, pH 2.9(0.1 mol/L); DetergentR2: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<24 hours: <8.0 mg/dL<48 hours: <12.0 mg/dL3 to 5 days: <15.0 mg/dL7 days: <15.0 mg/dLFull Term Newborn<24 hours: <6.0 mg/dL<48 hours: <10.0 mg/dL3 to 5 days: <12.0 mg/dL7 days: <10.0 mg/dLAdults0.3 – 1.2 mg/dL | Age:0-1 day: <8.0 mg/dL1-2 days: <12.0 mg/dL3-5 days: <16.0 mg/dL>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 areneonates and >29 days to 60 yearsare children and adults. |
| Instrument | ARCHITECT c8000 System | ADVIA® Chemistry 1800 System |
Substantial Equivalence Comparison of Technological Characteristics with the Predicate Device
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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.
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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 ofLevels | ObservedSampleRange(mg/dL) | AnalyticalMeasuringRange(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.
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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 concentrationtested that did not showsignificant 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 | <8.0 mg/dL |
| 1-2 days | <12.0 mg/dL |
| 3-5 days | <16.0 mg/dL |
| >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 |
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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).
§ 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.