ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

K981632 · Roche Diagnostics/Boehringer Mannheim GmbH · CIG · Jun 15, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981632
• Device Name: ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
• Applicant: Roche Diagnostics/Boehringer Mannheim GmbH
• Product Code: CIG · Clinical Chemistry
• Decision Date: Jun 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, 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.

Device Story

In vitro diagnostic reagent for quantitative measurement of total bilirubin in serum/plasma; utilizes diazo reaction where bilirubin couples with diazonium ion in acidic medium (pH 1-2) to form azobilirubin; color intensity proportional to total bilirubin concentration; measured photometrically on automated clinical chemistry analyzers; used in clinical laboratory settings by trained personnel; results assist clinicians in diagnosing/treating liver, hemolytic, hematological, and metabolic disorders; provides improved operational convenience via liquid, ready-to-use reagent format compared to lyophilized predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and performance comparison to predicate device.

Technological Characteristics

Liquid, ready-to-use diazo reagent system; utilizes photometric measurement of azobilirubin; designed for use on automated clinical chemistry analyzers; two-point calibration (saline blank and ~2.6 mg/dL standard); 5-week on-board reagent stability.

Indications for Use

Indicated for quantitative determination of total bilirubin in serum and plasma of adults and neonates for diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

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

• Roche Diagnostics, Boehringer Mannheim Total Bilirubin/DPD reagent system (K781921)

Submission Summary (Full Text)

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March 14, 2019

Roche Diagnostics/Boehringer Mannheim Gmbh Luann Ochs 9115 Hague Rd. Indianapolis, IN 46256

Re: k981632

Trade/Device Name: Liquid Total Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, MQM Dated: May 7, 1998 Received: May 8, 1998

Dear Luann Ochs:

This letter corrects our substantially equivalent letter of June 15, 1998.

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 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 medical devices and radiation-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 ([e-mail]) 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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510(k) Number (if known): Device Name: Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent

Indications for Use:

The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Zevices
510(k) Number K981633

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K981632

JUN 1 5 1998

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics, Boehringer Mannheim Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] |
| | Contact Person: Luann Ochs |
| | Date Prepared: May 7, 1998 |
| 2) Device name | Proprietary name: Roche Diagnostics, Boehringer Mannheim Liquid Total<br>Bilirubin Reagent |
| | Common name: bilirubin (total or direct) test system |
| | Classification name: Diazo colorimeter, bilirubin, 75CIG<br>Device Class II |
| 3) Predicate<br>device | We claim substantial equivalence to the currently marketed Roche Diagnostics.<br>Boehringer Mannheim Total Bilirubin/DPD reagent system, catalog number<br>1039034, a modification of the Single Vial DPD Total Bilirubin reagent<br>system, K781921. |
| 4) Device<br>Description | Total bilirubin, in the presence of a suitable solubilizing agent, is coupled with<br>a diazonium ion in a strongly acid medium (ph 1 - 2). |
| | Bilirubin + diazonium ion<br><span style="text-decoration:overline">acid</span><br>-> Azobilirubin |
| | The intensity of the color of the azobilirubin formed is proportional to the total<br>bilirubin concentration and can be measured photometrically. |

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### 510(k) Summary, Continued

The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent 5) Intended use is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.

#### The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent 6) Comparison is substantially equivalent to other products in commercial distribution to predicate intended for similar use. Most notably it is substantially equivalent to the device currently marketed Roche Diagnostics, Boehringer Mannheim Total Bilirubin/DPD reagent system, catalog number 1039034, a modification of the Single Vial DPD Total Bilirubin reagent system, K781921.

The following table illustrates the similarities between the Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent and the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI.

| Feature | New Liquid Total<br>Bilirubin Reagent | Predicate Total<br>Bilirubin Reagent |
|------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of total<br>bilirubin | Measurement of total<br>bilirubin |
| Sample Type | Serum or plasma, no<br>preparation required | Serum or plasma, no<br>preparation required |
| Use on Automated<br>Chemistry Analyzers? | Yes | Yes |
| Test Principle | Diazo reaction with<br>formation of an<br>azobilirubin product,<br>measured<br>spectrophotometrically | Diazo reaction with<br>formation of an<br>azobilirubin product,<br>measured<br>spectrophotometrically |
| Calibration | Two points, blank<br>(saline) and about 2.6<br>mg/dL total bilirubin | Two points, blank<br>(saline) and about 2.6<br>mg/dL total bilirubin |

#### Similarities:

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## 510(k) Summary, Continued

| Feature | New Liquid Total<br>Bilirubin Reagent | Predicate Total<br>Bilirubin Reagent |
|-------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Calibration Stability | Perform a new<br>calibration once a week,<br>or with a bottle or<br>reagent lot change | Perform a new<br>calibration once a week,<br>or with a bottle or<br>reagent lot change |
| Reagent On-board<br>Stability | 5 weeks | 5 days |
| Kit Configuration,<br>Reagent Preparation | R1, liquid, ready-to-use<br>R2, liquid, ready-to-use | R1a, lyophilized,<br>requires reconstitution<br>with buffer<br>R1, buffer |

6) Comparison to predicate device (continued)

#### 6) Comparison Differences: to predicate device, continued

There are no significant differences between the Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent and the predicate device for purposes of considering substantial equivalence.

#### Performance characteristics:

The performance of the Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics, Boehringer Mannheim Total Bilirubin/DPD reagent system, catalog number 1039034, a modification of the Single Vial DPD Total Bilirubin reagent system, K781921.