ARCHITECT TOTAL BILIRUBIN

K121985 · Abbott Laboratories · CIG · Feb 1, 2013 · Clinical Chemistry

Device Facts

• Record ID: K121985
• Device Name: ARCHITECT TOTAL BILIRUBIN
• Applicant: Abbott Laboratories
• Product Code: CIG · Clinical Chemistry
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma 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).

Device Story

ARCHITECT Total Bilirubin is an in vitro diagnostic assay for use on the ARCHITECT c8000 system. It measures total bilirubin (conjugated and unconjugated) in human serum or plasma. Principle of operation: colorimetric chemical reaction where bilirubin couples with diazo reagent in the presence of a surfactant to form azobilirubin. The device measures the increase in absorbance at 548 nm, which is directly proportional to total bilirubin concentration. Operated by laboratory personnel in clinical settings. Output is a quantitative concentration value used by physicians to diagnose and monitor liver, hemolytic, and metabolic disorders, and to assess kernicterus risk in neonates.

Clinical Evidence

Bench testing only. Precision studies (N=80, 20-day; N=50, 5-day) showed total %CV between 1.0% and 3.0%. Linearity confirmed across 0.1–25 mg/dL range (r=1.00). Method comparison with predicate (N=138 adults) yielded slope 0.98, intercept 0.07, r=0.9991. Comparison with Roche assay (N=54 neonates) yielded slope 0.99, intercept 0.32, r=0.9967. Interference testing showed no significant interference from hemoglobin (up to 2000 mg/dL); Intralipid (>750 mg/dL) and Indican (>0.175 mmol/L) interfere.

Technological Characteristics

Quantitative, enzymatic, colorimetric assay. Reagents: R1 (surfactants, HCl), R2 (2,4-dichloroaniline, HCl, sodium nitrite). Platform: ARCHITECT c8000 analyzer. Measuring range: 0.1–25 mg/dL. Detection: End-point colorimetric at 548 nm. Calibration: 3-point curve. Sample volume: 2.6 μL. Standards: CLSI C28-A3, EP5-A2, EP6-A, EP7-A2, EP9-A2, EP17-A.

Indications for Use

Indicated for quantitative analysis of total bilirubin in human serum or plasma of adults and neonates to aid in diagnosis/treatment of liver, hemolytic hematological, and metabolic disorders (e.g., hepatitis, gall bladder block) and to assess risk of bilirubin encephalopathy (kernicterus) in newborns.

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.

Predicate Devices

• Abbott Total Bilirubin assay (K060574)

Reference Devices

• Roche total bilirubin on Hitachi 717

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

March 14, 2019

Abbott Laboratories Linda Morris 1921 Hurd Drive Irving, TX 75038

Re: K121985

Trade/Device Name: ARCHITECT Total Bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin Test system Regulatory Class: Class II Product Code: CIG, MQM Dated: December 20, 2012 Received: December 21, 2012

Dear Linda Morris:

This letter corrects our substantially equivalent letter of February 1, 2013.

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 Part

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801 and Part 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# 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): k121985

Device Name: ARCHITECT Total Bilirubin

Indications For Use:

The ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma 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).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR .

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung W. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k121985 510(k) ==

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121985

## 510(k) Summary

### FEB 0 .1 2013

#### Submitter's Name/Address

Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

...

Contact Person Linda Morris Senior Regulatory Specialist MS 2-11 Regulatory Affairs [phone] Fax [phone]

Date of Preparation of this Summary: Device Trade or Proprietary Name: Device Common/Usual Name or Classification Name: Classification Number/Class:

January 30, 2013 ARCHITECT Total Bilirubin Total Bilirubin Reagent

CIG/Class II

· This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 10 - - - -

#### Test Description:

ARCHITECT Total Bilirubin is an in vitro diagnostic assay for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates. Total (conjugated and unconjugated) bilirubin couples with the diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration.

Total Bilirubin 510(k) Revised January31, 2013

.

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#### Substantial Equivalence:

The modified ARCHITECT Total Bilirubin assay is substantially equivalent to the Abbott Total Bilirubin assay (K060574) on the ARCHITECT c8000 Analyzer. These assays yield substantially equivalent Performance Characteristics.

#### Similarities:

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- . Both assays are in vitro colorimetric chemical reactions.
- Both assays can be used for the quantitative analysis of total bilirubin in human . serum or plasma of adults and neonates.
- . Both assays yield similar results.

#### Differences:

The modified ARCHITECT Total Bilirubin assay has a smaller sample size of 2.6 uL when compared to the Abbott Total Bilirubin (K060574) assay sample size of 4.0 uL.

#### Intended Use:

. The ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma 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).

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#### Performance Characteristics:

Adult Application: The Total Bilirubin assay method comparison yielded acceptable correlation between the original Total Bilirubin assay and the modified ARCHITECT Total Bilirubin assay. One hundred One hundred thirty-eight adult serum samples ranging from 0.11 to 23.96 mg/dL (based on the Total Bilirubin assay results) showed a correlation coefficient of 0.9991, slope of 0.98, and Y-intercept of 0.07 mg/dL using the ARCHITECT c8000 System.

Neonate Application: Fifty-four neonate serum samples ranging from 0.94 to 19.05 mg/dL (based on the Roche Total Bilirubin assay on the Hitachi 717 Analyzer assay results) showed a correlation coefficient of 0.9967, slope of 0.99, and Y-intercept of 0.32 mg/dL using the ARCHITECT c8000 System.

Precision studies were conducted using the Total Bilirubin assay. On the ARCHITECT c8000 System, the total %CV for Level 1 is 1.96%, Level 2 is 1.43%, Level 3 is 1.20%, and Level 4 is 1.00%. The ARCHITECT Total Bilirubin assay is linear from 0.1 to 25.0 mg/dL. The functional sensitivity (limit of quantitation) of the ARCHITECT Total Bilirubin assay is < 0.1 mg/dL and the limit of detection (LOD) 0.05 mg/dL.

These.data demonstrate the performance of the modified ARCHITECT Total Bilirubin assay is substantially equivalent to the performance of AbbottTotal Bilirubin assay.

#### Conclusion:

Based on analytical and clinical studies, the modified ARCHITECT Total Bilirubin assay is substantially equivalent to the performance of the AbbottTotal Bilirubin assay (k06574).