Total Bilirubin

K150510 · Abbott Laboratories · CIG · Apr 2, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150510
• Device Name: Total Bilirubin
• Applicant: Abbott Laboratories
• Product Code: CIG · Clinical Chemistry
• Decision Date: Apr 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended 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).

Device Story

Device is an in vitro diagnostic reagent kit for quantitative analysis of total bilirubin in human serum or plasma; used on ARCHITECT c8000 System. Principle: total bilirubin couples with diazo reagent in presence of surfactant to form azobilirubin; increase in absorbance at 548 nm is directly proportional to total bilirubin concentration. Operated by laboratory personnel in clinical settings. Output is a numerical concentration value (mg/dL). Healthcare providers use results to diagnose and monitor liver, hematological, and metabolic disorders; in neonates, results aid in assessing risk of bilirubin encephalopathy. Benefits include rapid, automated assessment of bilirubin levels to guide clinical management of jaundice and related conditions.

Clinical Evidence

Bench testing only. Performance validated via LoB/LoD/LoQ (LoQ 0.174 mg/dL), linearity (0.3-25.0 mg/dL), and 20-day precision studies. Method comparison (N=124 adults, N=64 neonates) against predicate showed high correlation (r=0.9994 for adults, r=0.9982 for neonates). Interference testing evaluated hemoglobin, Intralipid, and indican. Matrix equivalence confirmed for various tube types (serum, SST, EDTA, heparin).

Technological Characteristics

In vitro diagnostic reagent kit. Principle: End-point colorimetric diazo reaction. Reagents: R1 (surfactants, HCl), R2 (2,4-dichloroaniline, HCl, sodium nitrite, surfactant). Form factor: Liquid reagents for automated analyzer (ARCHITECT c8000). Detection: Absorbance at 548 nm. Connectivity: Integrated with ARCHITECT c8000 system.

Indications for Use

Indicated for quantitation of total bilirubin in human serum or plasma of adults and neonates. Used to diagnose/treat liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, gall bladder block). In neonates, used to measure bilirubin levels to aid in assessing risk of bilirubin encephalopathy (kernicterus).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] Fax: [phone] Email: [e-mail]

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

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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<br>Characteristics | Total Bilirubin | | Predicate Total Bilirubin<br>Assay (K121985 ) on the<br>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 | | | | |
| | < 24 Hours | < 8.0 | | | |
| | < 48 Hours | < 12.0 | | | |
| | 3 to 5 Days | < 15.0 | | | |
| | 7 Days | < 15.0 | | | |
| | Full Term Newborn | | | | |
| | < 24 Hours | < 6.0 | | | |
| | < 48 Hours | < 10.0 | | | |
| | 3 to 5 Days | < 12.0 | | | |
| | 7 Days | < 10.0 | | | |
| Reference Range - | 0.3 to 1.2 mg/dL | | 0.2 to 1.2 mg/dL | | |
| Adult | | | | | |
| Reagent | R1: | | R1: | | |
| Formulation | Surfactants | 10.57% | Surfactants | 4.51% | |
| | HCl | 6.563 g/L | HCl | 8.204 g/L | |
| | | | | | |
| | R2: | | R2: (Same) | | |
| | 2,4-dichloroaniline | 0.81 g/L | 2,4-dichloroaniline | 0.81 g/L | |
| | HCl | 5.563 g/L | HCl | 5.563 g/L | |
| | Sodium nitrite | 0.345 g/L | Sodium nitrite | 0.345 g/L | |
| | Surfactant | 1.96% | Surfactant | 1.96% | |

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#### 7. Summary of Performance Testing

Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOQ) The study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2. LoB was determined using 4 samples prepared with human serum albumin (zero-analyte samples). LoD and LoQ were 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. The zero-analyte samples were tested in a minimum of 5 replicates on 5 separate runs. The low-analyte samples were 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 c 8000 instruments. Each reagent lot was matched with a different lot of calibrator.

LOQ is defined as the lowest concentration at which an assay can meet the total allowable error, which includes bias and imprecision. LOQ is based on 180 results meeting the <10% bias acceptance criteria. Therefore, the LOD is equivalent to LOQ.

The LoQ of the Total Bilirubin assay is 0.174 mg/dL. The LoO 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

Linearity was determined based on guidance from National Committee for Clinical Laboratory Standards (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

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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 c 8000 instrument. All levels in a sample set were tested in the same run.

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)

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 c 8000 instruments. During each run, a given reagent lot/calibrator lot combination was randomly tested. Therefore, for each instrument, the 20 days of testing included up to 4 instrument/reagent lot combinations.

The analysis was performed based on guidance from National Committee for Clinical Laboratory Standards (NCCLS) document EP5-A2.

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# Results Table:

| | | | Within Run | | Total | |
|--------|----|------------------|----------------|-----|----------------|-----|
| Sample | N | Mean<br>(mg/dL) | SD<br>(mg/dL) | %CV | SD<br>(mg/dL) | %CV |
| 1 | 80 | 0.87 | 0.010 | 1.2 | 0.018 | 2.1 |
| 2 | 80 | 4.53 | 0.034 | 0.8 | 0.057 | 1.3 |
| 3 | 80 | 6.42 | 0.041 | 0.6 | 0.066 | 1.0 |
| 4 | 80 | 16.85 | 0.115 | 0.7 | 0.204 | 1.2 |
| | | | Within Run | | Total | |
| Sample | N | Mean<br>(µmol/L) | SD<br>(µmol/L) | %CV | SD<br>(µmol/L) | %CV |
| 1 | 80 | 14.90 | 0.17 | 1.2 | 0.31 | 2.1 |
| 2 | 80 | 77.57 | 0.58 | 0.8 | 0.97 | 1.3 |
| 3 | 80 | 109.93 | 0.70 | 0.6 | 1.13 | 1.0 |

# 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 concnetrations (15mg/dL and 1.2 mg/dL, respectively). A bias of > 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<br>Substance | Interferent<br>Concentration | Control<br>(mg/dL) | Observed Diff<br>(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<br>Substance | Interferent<br>Concentration | Control<br>(µmol/L) | Observed Diff<br>(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<br>Coefficient | Range<br>(mg/dL) |
|-----|-------|-----------|----------------------------|------------------|
| 118 | 0.99 | -0.09 | 0.9994 | 0.3 to 24.8 |

#### Neonate Population Representative Data

| N | Slope | Intercept | Correlation<br>Coefficient | Range<br>(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 < 0.3 mg/dL).

The reference range was determined to be 0.3 mg/dL to 1.2 mg/dL.

### 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

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6 in the same run as the autodiluted samples using 1 lot of reagents on one ARCHITECT c 8000 System.

The Total Bilirubin assay met the acceptance criteria of a difference between the autodilution mean concentration and the manual dilution mean concentration of ≤ 10% bias. For Total Bilirubin samples greater than 25 mg/dL, either the System Automated Dilution protocol or Manual Dilution protocol can be performed.

### 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. 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 c 8000 System. All samples collected from the same subject were tested in the same run.

Deming linear regression analysis was performed using the first set of results obtained. Results summarized below demonstrated that the following blood collection tube types are acceptable for use with the Total Bilirubin assay:

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| Tube Type | N | Slope | Intercept | Correlation<br>Coefficient |
|------------------------------------------------|----|-------|-----------|----------------------------|
| Serum (glass) | 41 | 0.96 | 0.06 | 0.9990 |
| Serum Separator Tube (SST) | 40 | 1.00 | 0.00 | 0.9996 |
| Ethylenediaminetetraacetic Acid<br>(EDTA) | 39 | 1.00 | -0.01 | 0.9990 |
| Lithium Heparin | 40 | 1.01 | 0.02 | 0.9994 |
| Lithium Heparin Plasma<br>Separator Tube (PST) | 40 | 0.96 | 0.05 | 0.9992 |
| Sodium Heparin | 39 | 0.98 | 0.03 | 0.9996 |

Tube type limitation: Tubes containing sodium flouride/potassium oxalate are not recommended due to the potential for hemolysis.

# 8. Conclusion Drawn from Performance Testing

The results presented in this 510(k) premarket notification demonstrate that the candidate Total Bilirubin assay performance is substantially equivalent to the predicate assay (Total Bilirubin, K121985).