DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212

K061719 · Dade Behring, Inc. · CIG · Aug 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061719
• Device Name: DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
• Applicant: Dade Behring, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Aug 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

TBIL Flex® reagent cartridge: The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease. TDBIL Calibrator: The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.

Device Story

Device consists of TBIL Flex® reagent cartridge and TDBIL calibrator for use on Dimension Vista™ System. Input: human serum or plasma sample. Principle: diazo chemistry; bilirubin solubilized via caffeine/benzoate/acetate/EDTA; reacts with diazotized sulfanilic acid to form red chromophore; absorbance measured at 540/700 nm (bichromatic endpoint). System performs sample blank correction. Calibrator is lyophilized human serum spiked with ditaurobilirubin, traceable to NIST SRM 916a. Used in clinical laboratory settings by trained personnel. Output: quantitative total bilirubin concentration. Results assist clinicians in diagnosing/treating liver, hemolytic, and metabolic disorders.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (20 days, 2 runs/day). Linearity confirmed 0.1-25.0 mg/dL (slope 0.98, r=1.000). Analytical sensitivity 0.05 mg/dL. Interference testing per CLSI EP7-A2 evaluated exogenous (levodopa, phenazopyridine, etc.) and endogenous (hemoglobin, lipids) substances. Method comparison with predicate (n=150) showed slope 0.942, intercept 0.039 mg/dL, r=0.999. Matrix comparison (n=64) confirmed agreement between serum, EDTA plasma, and lithium heparin plasma.

Technological Characteristics

Quantitative absorbance assay. Reagents: caffeine, EDTA, sulfanilic acid, sodium nitrite. Bichromatic endpoint measurement (540/700 nm). Calibrator: lyophilized bilirubin-depleted human serum with ditaurobilirubin. System: Dimension Vista™ Integrated System. Standards: CLSI EP5-A, EP7-A, EP09-A2, ISO 14971, ISO 15223. Sterilization: N/A (reagents). Connectivity: Integrated system.

Indications for Use

Indicated for quantitative measurement of total bilirubin in human serum and plasma for patients requiring diagnosis or treatment of liver, hemolytic hematological, or metabolic disorders (e.g., hepatitis, gall bladder disease).

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

• Dade Behring Dimension® TBIL Flex® reagent cartridge and TBIL/DBIL Calibrator (k861700)

Submission Summary (Full Text)

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2006

### 510(k) Summary

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.

| Submitter's Name: | George M. Plummer<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>302-631-9798<br>302-631-6299 (fax) | AUG 25 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|--------|
| Date of Preparation: | June 16, 2006 | |
| Name of Products: | Dimension Vista™ TBIL Flex® reagent cartridge<br>Dimension Vista™ TDBIL Calibrator | |
| FDA Classification Name: | Bilirubin (total or direct) test system<br>Bilirubin Calibrator | |
| Predicate Device: | Dade Behring Dimension® TBIL Flex® reagent cartridge and<br>TBIL/DBIL Calibrator (k861700) | |

### Device Description:

### TBIL Flex® reagent cartridge

Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. Bilirubin (unconjugated) in the sample is solubilized by dilution in a mixture of caffeine/benzoate/acetate/EDTA. Upon addition of the diazotized sulfanilic acid, the solubilized bilirubin including conjugated bilirubins (mono and diglucoronides) and the delta form (biliprotein-bilirubin covalently bound to albumin) is converted to diazo-bilirubin, a red chromophore representing the total bilirubin which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique. A sample blank correction is used.

Solubilized bilirubin + Diazotized sulfanilic acid ---------------------------------------------------------------------------------------------------------------------------

### Total bilirubin and Direct bilirubin calibrator.

The TDBIL calibrator is a two level calibrator. Level 1, purified water, is provided through the on-board Dimension Vista™ system. Level 2 is a lyophilized human serum based material spiked with ditaurobilirubin and traceable to NIST Standard Reference Material 916a.

### Intended Use:

### TBIL Flex® reagent cartridge:

The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.

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TDBIL Calibrator:

The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.

### Comparison to the predicate device:

The TBIL Flex® reagent cartridge and TDBIL Calibrator are substantially equivalent in intended use, principle and performance to the predicate Dade Behring TBIL assay and TBIL/DBIL Calibrator, k861700. The assays are in vitro assays with intended use for the measurement of total bilirubin in human serum and plasma. Both calibrators are for use of calibration of the total and direct bilirubin in vitro assays.

A summary of the features of the predicate and Dimension Vista™ TBIL Flex® reagent cartridge assays is provided in the following chart. Although the intended use statements have been modified for the test assay to align with CFR 862.1110, there are no different claims for the test assay.

| Attribute | Dimension® TBIL Assay (predicate) | Dimension Vista™ TBIL Assay |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The TBIL method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of total bilirubin in serum and plasma. | The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease. |
| Sample type | Human serum and plasma | Human serum and plasma |
| Methodology | Photometric (diazo chemistry) | Photometric (diazo chemistry) |
| Detection | Bichromatic (540, 700 nm) | Bichromatic (540, 700 nm) |
| Sample volume | 28 uL | 5 uL |
| Hemoglobin Correction | Up to 500 mg/dL Hemoglobin | Up to 1000 mg/dL Hemoglobin |
| Analytical Sensitivity | Not provided | 0.1 mg/dL |
| Within Lab Precision | 2.4%CV at 0.9 mg/dL<br>9.6%CV @ 18.9 mg/dL | 5%CV @ 0.9 mg/dL<br>2.9%CV @ 19.3 mg/dL |
| Reference Interval | < 1 mg/dL | <1 mg/dL |

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| Attribute | Dimension® TBIL/DBIL<br>Calibrator (predicate) | Dimension Vista™ TDBIL<br>Calibrator |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Dimension® Bilirubin<br>Calibrator is an in vitro<br>diagnostic product to be used<br>to calibrate the Dimension®<br>clinical chemistry system for<br>the Direct Bilirubin (DBIL)<br>and Total Bilirubin (TBIL)<br>methods. This product was<br>designed to meet the needs of<br>users to assure accurate results<br>over the assay range of these<br>methods. | The TDBIL CAL is an in<br>vitro diagnostic product for<br>calibration of the Direct<br>Bilirubin (DBIL) and Total<br>Bilirubin (TBIL) methods on<br>the Dimension Vista™<br>System. |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human serum | Human serum |
| Levels | Three | One |
| Bilirubin concentration (mg/dL)<br>Total (TBIL)<br>Direct (DBIL) | L1 (0.8), L2 (9.4), L3 (21)<br>L1 (0.6), L2 (6.9), L3 (14.5) | Level 2 (27.5)<br>Level 2 (19.25)<br>On-board purified system<br>water is used for level 1. |
| Form | Lyophilized | Lyophilized |
| Volume | 6 vials, 2 vials each level, 1<br>mL each vial (hydrated<br>volume) | 3 vials, 1mL each vial<br>(hydrated volume). |

A summary of the features of the predicate and Dade Behring Dimension TDBIL calibrator is provided in the following chart.

## Comments on Substantial Equivalence:

Testing results demonstrate that the Dimension Vista™ TBIL Flex® reagent cartridge and the associated TDBIL Calibrator are equivalent to the predicate devices. Method comparison results provided a slope of 0.94, intercept of 0.4 mg/dL and correlation of 0.999.

### Conclusion:

The Dimension Vista™ TBIL Flex® reagent cartridge and the associated TDBIL Calibrator are substantially equivalent in principle and performance to the predicate products.

> George M. Plummer Quality Assurance and Compliance Manager Date: June 16, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing service to the people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 2 5 2006

George M. Plummer Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Business Community P.O. Box 6101, Mailstop 514 Newark, DE, 19714-6101

Re: k061719

Trade/Device Name: TBIL Flex® reagent cartridge TDBIL Calibrator Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, JIT Dated: June 16, 2006 Received: June 19, 2006

Dear Mr. Plummer,

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications For Use Statement

510(k) Number (if known): { 06/719

Device Name:

TBIL Flex® reagent cartridge TDBIL Calibrator

Indications for Use:

TBIL Flex® reagent cartridge:

The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista 100 System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.

#### TDBIL Calibrator:

The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.

Prescription Use X (Per 21 CRF 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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic Device Evaluation and Safety

061719