DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125

K061839 · Dade Behring, Inc. · CIG · Aug 29, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061839
• Device Name: DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
• Applicant: Dade Behring, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Aug 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

The DBIL Flex® reagent cartridge is an in vitro diagnostic assay for use on the Dimension Vista™ System. It processes human serum or plasma samples using diazo chemistry. The sample is diluted in 0.5M HCl; a blank reading is taken to eliminate non-bilirubin pigment interference. Diazotized sulfanilic acid is added to convert conjugated bilirubin into a red chromophore. The system measures absorbance at 540 nm and 700 nm using a bichromatic endpoint technique. The device is operated by laboratory personnel in a clinical setting. Results are provided to healthcare providers to assist in the diagnosis and management of liver, hemolytic, hematological, and metabolic disorders. The device provides automated hemoglobin flagging.

Clinical Evidence

Bench testing only. Precision evaluated via 20-day ANOVA (CLSI EP5-A2); repeatability CVs ranged 1.1%–8.9%. Linearity confirmed across 0.05–16.0 mg/dL range (r=0.999). Method comparison with predicate (n=150) showed slope 0.971, r=0.999. Matrix comparison (serum, EDTA, lithium heparin) showed excellent agreement (r=0.994–0.998). Interference testing performed per CLSI EP7-A; hemoglobin interference noted at ≥50 mg/dL.

Technological Characteristics

Photometric diazo colorimetry; bichromatic endpoint detection (540/700 nm). Reagent cartridge format for Dimension Vista™ System. Analyte: direct bilirubin. Reportable range: 0.05–16.0 mg/dL. Analytical sensitivity: 0.05 mg/dL. Standards: CLSI EP5-A2, EP7-A, EP9-A2; ISO 14971, ISO 15223.

Indications for Use

Indicated for quantitative measurement of direct (conjugated) bilirubin in human serum and plasma to aid in diagnosis/treatment of liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, gall bladder disease). Not established for neonates.

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 DBIL Flex® reagent cartridge (k862359)

Submission Summary (Full Text)

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# AUG 2 9 2006

#### 510(k) Summarv

Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically "KO61839". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The sequence consists of two uppercase letters, "K" and "O", followed by the numbers 6, 1, 8, 3, and 9.

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) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | June 28, 2006 |
| Name of Products: | DBIL Flex® reagent cartridge |
| FDA Classification Name: | Bilirubin (total or direct) test system |
| Predicate Device: | Dade Behring DBIL Flex® reagent cartridge (k862359) |

#### Device Description:

Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. The sample is diluted in 0.5M HCl. A blank reading is taken to eliminate interference from nonbilirubin pigments. Upon addition of the diazotized sulfanilic acid, the conjugated bilirubin is converted to diazo-bilirubin, a red chromophore which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique.

Conjugated bilirubin + Diazotized sulfanilic acid ----------------------------------------------------------------------------------------------------------------------------

### Intended Use:

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

### Comparison to the predicate device:

The DBIL Flex® reagent cartridge is substantially equivalent in intended use, principle and performance to the predicate Dade Behring DBIL assay, k862359. The assay is an in vitro assay with intended use for the measurement of direct bilirubin in human serum and plasma.

A summary of the features of the predicate and the Dimension Vista™ DBIL Flex® reagent cartridge assay is provided in the following chart. Although the intended use statement has been

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K061839

modified for the test assay to align with CFR 862.1110, there are no different claims for the test assay.

| Attribute | Dimension® DBIL<br>Assay (k862359) | Dimension Vista™ DBIL |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DBIL method used<br>on the Dimension®<br>clinical chemistry<br>system is an <i>in vitro</i><br>diagnostic test intended<br>for the quantitative<br>determination of direct<br>(conjugated) bilirubin in<br>serum and plasma. | The DBIL method is an <i>in vitro</i><br>diagnostic test for the quantitative<br>measurement of direct (conjugated)<br>bilirubin in human serum and plasma<br>on the Dimension Vista™ System.<br>Measurements of direct bilirubin are<br>used in the diagnosis and treatment<br>of liver, hemolytic, hematological<br>and metabolic disorders, including<br>hepatitis and gall bladder disease. |
| Sample type | Human serum and<br>plasma | Human serum and plasma |
| Methodology | Photometric (diazo<br>chemistry) | Photometric (diazo chemistry) |
| Detection | Bichromatic (540, 700<br>nm) | Bichromatic (540, 700 nm) |
| Sample volume | 31 uL | 5 uL |
| Hemoglobin Flag | Yes | Yes |
| Analytical<br>Sensitivity | Not provided | 0.05 mg/dL |
| Repeatability | 4.7 %CV at 5 mg/dL | 9.1%CV @ 0.4 mg/dL<br>2.1%CV @ 5.9 mg/dL |
| Reference<br>Interval | < 0.3 mg/dL | <0.2 g/dL |

## Comments on Substantial Equivalence:

Testing results demonstrate that the Dimension Vista™ DBIL Flex® reagent cartridge is equivalent to the predicate device. Method comparison results provided a slope of 0.97, intercept of 0.01 mg/dL and correlation of 0.999.

#### Conclusion:

The Dimension Vista™ DBIL Flex® reagent cartridge is substantially equivalent in principle and performance to the predicate product.

> George M. Plummer Quality Assurance and Compliance Manager Date: June 28, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 9 2006

Mr. George M. Plummer Dade Behring, Inc. P.O. Box 6101, Mailstop 514 Newark, DE 19714

Re: k061839

> Trade/Device Name: DBIL Flex® reagent cartridge Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: June 28, 2006 Received: June 29, 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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Page 2 -

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 G. A.

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

5 10(k) Number (if known):

Kd6/839

Device Name:

DBIL Flex® reagent cartridge

Indications for Use:

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

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)

Carol Benson

Livision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K061839