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 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.

AI/ML Overview

The provided text describes the 510(k) summary for the DBIL Flex® reagent cartridge, which is an in vitro diagnostic test for measuring direct (conjugated) bilirubin in human serum and plasma. The study presented is a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative sense as might be found for a clinical outcome. Instead, it presents performance characteristics of the new device and compares them to a predicate device, aiming to show "substantial equivalence." The "acceptance" can be inferred from the "Conclusion" statement: "The Dimension Vista™ DBIL Flex® reagent cartridge is substantially equivalent in principle and performance to the predicate product."

The key performance characteristics reported are:

Performance Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Dimension Vista™ DBIL Flex®)
Intended Use	Quantitative determination of direct (conjugated) bilirubin in serum and plasma on the Dimension® clinical chemistry system.	Quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista™ System. Used in 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	31 uL	5 uL
Hemoglobin Flag	Yes	Yes
Analytical Sensitivity	Not provided	0.05 mg/dL
Repeatability	4.7 %CV at 5 mg/dL	9.1%CV @ 0.4 mg/dL 2.1%CV @ 5.9 mg/dL
Reference Interval	< 0.3 mg/dL	< 0.2 mg/dL
Method Comparison	(Implied to be very close to 1:1 with predicate)	Slope: 0.97 Intercept: 0.01 mg/dL Correlation: 0.999

Note on "Acceptance Criteria": For a 510(k) submission like this, the "acceptance criteria" for substantial equivalence are generally that the new device performs as well as, or better than, the predicate device in relevant analytical performance characteristics, and has the same intended use. The method comparison results (slope, intercept, correlation) are key metrics demonstrating this.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Method comparison results provided a slope of 0.97, intercept of 0.01 mg/dL and correlation of 0.999." However, it does not specify the sample size used for this method comparison study or the data provenance (e.g., country of origin, retrospective or prospective). This information is typically detailed in the full study report, which is not included in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of diagnostic test (quantitative measurement of a biomarker) does not typically involve human experts establishing "ground truth" in the way, for example, an imaging AI system would. The "ground truth" for the method comparison is the measurement obtained from the predicate device on the same samples. Therefore, this section is not applicable (N/A) in the context of this device.

4. Adjudication Method for the Test Set

Since the "ground truth" is derived from the predicate device's measurements, there is no need for an adjudication method involving human readers. This section is not applicable (N/A).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was described. This device is an in vitro diagnostic assay, not an imaging AI or decision support system that would typically employ human readers. This section is not applicable (N/A).

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The entire evaluation presented is of the device (reagent cartridge on the Dimension Vista™ System), which operates as an automated quantitative measurement system. It does not involve a "human-in-the-loop" once the sample is loaded. Therefore, the reported performance characteristics (analytical sensitivity, repeatability, method comparison) represent its standalone performance.

7. Type of Ground Truth Used

The "ground truth" used for comparison in this study is the measurement obtained from the legally marketed predicate device (Dade Behring DBIL assay, K862359) on the same samples. This is a common approach for establishing substantial equivalence for IVDs.

8. Sample Size for the Training Set

The document is a 510(k) summary for an in vitro diagnostic reagent cartridge. This type of device relies on established chemical principles (diazotized sulfanilic acid reaction) and calibration procedures, rather than machine learning algorithms that require "training sets" in the conventional sense. Therefore, this section is not applicable (N/A).

9. How the Ground Truth for the Training Set Was Established

As noted above, this device does not utilize a machine learning "training set." Its analytical performance is validated through traditional analytical chemistry and clinical laboratory methods. This section is not applicable (N/A).

Summary

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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. PlummerDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101302-631-9798302-631-6299 (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:

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

Intended Use:

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® DBILAssay (K862359)	Dimension Vista™ DBIL
Intended Use	The DBIL method usedon the Dimension®clinical chemistrysystem is an in vitrodiagnostic test intendedfor the quantitativedetermination of direct(conjugated) bilirubin inserum and plasma.	The DBIL method is an in vitrodiagnostic test for the quantitativemeasurement of direct (conjugated)bilirubin in human serum and plasmaon the Dimension Vista™ System.Measurements of direct bilirubin areused in the diagnosis and treatmentof liver, hemolytic, hematologicaland metabolic disorders, includinghepatitis and gall bladder disease.
Sample type	Human serum andplasma	Human serum and plasma
Methodology	Photometric (diazochemistry)	Photometric (diazo chemistry)
Detection	Bichromatic (540, 700nm)	Bichromatic (540, 700 nm)
Sample volume	31 uL	5 uL
Hemoglobin Flag	Yes	Yes
AnalyticalSensitivity	Not provided	0.05 mg/dL
Repeatability	4.7 %CV at 5 mg/dL	9.1%CV @ 0.4 mg/dL2.1%CV @ 5.9 mg/dL
ReferenceInterval	< 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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
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.(b)
Classification. Class II.