ATAC TOTAL BILIRUBIN REAGENT

K030014 · Elan Diagnostics · CIG · Sep 26, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030014
• Device Name: ATAC TOTAL BILIRUBIN REAGENT
• Applicant: Elan Diagnostics
• Product Code: CIG · Clinical Chemistry
• Decision Date: Sep 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The ATAC Total Bilirubin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Device Story

Reagent kit for quantitative total bilirubin measurement in serum/plasma; used with ATAC 8000 Random Access Chemistry System. Principle: reaction with diazotized sulfanilic acid in presence of dimethylsulfoxide forms red-purple complex; absorbance measured at 546 nm. Absorbance increase proportional to bilirubin concentration. Operated by trained personnel in professional clinical laboratory settings. Output provides bilirubin concentration values to clinicians for diagnosing/treating liver, hematological, and metabolic disorders.

Clinical Evidence

Bench testing only. Precision evaluated over 7 days (n=36 per sample); total CV ranged from 2.7% to 16.3%. Linearity established up to 25 mg/dL. Interference testing performed for heparin, hemoglobin, and triglycerides. Method comparison study (n=120) against predicate device yielded Deming regression: y = 1.013x - 0.05 mg/dL (Sy.x = 0.31 mg/dL).

Technological Characteristics

Two-reagent kit: Reagent 1 (sulfanilic acid, hydrochloric acid, 50% DMSO) and Reagent 2 (sodium nitrite). Quantitative diazo colorimetric assay. Measurement at 546 nm. Requires ATAC® 8000 Random Access Chemistry System. Calibrator traceable to NIST reference materials.

Indications for Use

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

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

• Beckman Synchron Total Bilirubin Reagent (product 442745)

Submission Summary (Full Text)

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SEP 2 6 2003

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1075 W. Lambert Road Building D Brea, California 92821 T [phone] F [phone]

## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION

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 ATAC Total Bilirubin Reagent Kit is intended for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block. The ATAC Total Bilirubin Reagent determines total bilirubin through its reaction with diazotized sulfanilic acid in the presence of dimethylsulfoxide to form a red-purplex. The resulting increase in absorbance at 546 nm is proportional to the total bilirubin concentration in the sample.

The ATAC Total Bilirubin Reagent Kit is substantially equivalent to the Beckman Synchron Total Bilirubin Reagent, product 442745, which is currently marketed by Beckman Coulter, Inc of Brea, CA. The effectiveness of ATAC Total Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.

The recovery of total bilirubin using the ATAC Total Bilirubin Reagent is linear from 0.1 to 25 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard values. These statistics are shown below.

(ATAC Recoveries) = 0.3 mg/dL + 0.87 x (Standard Factors), Sy.x = 0.28 mg/dL, r = 1.000, n = 18

Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.

| Sample | n | mean | Within Run | | Total | |
|---------|----|------|------------|------|-------|-------|
| | | | 1SD | %CV | 1SD | %CV |
| Serum 1 | 36 | 0.6 | 0.04 | 6.5% | 0.10 | 16.3% |
| Serum 2 | 36 | 3.4 | 0.06 | 1.6% | 0.11 | 3.1% |
| Serum 3 | 36 | 6.3 | 0.12 | 1.9% | 0.17 | 2.7% |

Mixed serum and plasma specimens, collected from adult patients, were assayed for total bilirubin using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.

ATAC 8000 = - 0.05 mg/dL + 1.003 x Competitive Reagent sy.x = 0.20 mg/dL range = 0.2 - 25.7 mg/dL n = 107

The detection limit of 0.1 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.49 mg/dL. Consequently, the detection limit is reported as the round-off error of the assay.

The 5 day onboard reagent stability and 24 hour calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, estimates of the bilirubin recoveries over the test periods are less than 0.15 mg/dL. In addition, the observed shifts in recoveries over the 24 hour calibration stability period average less than 0.1 mg/dL.

The 14 day reconstituted stability claim is documented through the assay of serum pools and linearity standards. Observed shifts in recoveries over the 14 day period are less than 0.1 mg/dL or 2.5%.

Wyman Stodden

Wynn/Stocking Manager of Regulatory Affair Elan, Brea California

510(k) Notification, ATAC Total Bilirubin Reagent Kit, 31 December, 2002, p 47

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that converge at the top and then separate into two wavy lines at the bottom.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 2 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Suite D Brea, CA 92821

Re: k030014

Trade/Device Name: ATAC Total Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: June 30, 2003 Received: July 1, 2003

Dear Mr. Thiel:

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. Iisting 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/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K030014

510(k) Number (if known):

Device Name:

ATAC Total Bilirubin Reagent

Indications for Use:

The ATAC Total Bilirubin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K63084

OR

Over-The-Counter Use

Prescription Use √
(Per 21 CFR 801.109)

(Optional Format 1-2-96)