DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR

K053090 · Beckman Coulter, Inc. · JFM · Dec 16, 2005 · Clinical Chemistry

Device Facts

• Record ID: K053090
• Device Name: DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: JFM · Clinical Chemistry
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the Synchron® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

Device Story

Dri-STAT® Enzymatic Bilirubin Reagent is an in vitro diagnostic reagent kit used with SYNCHRON® Systems to measure total bilirubin in human serum and plasma. The system utilizes an enzymatic methodology to quantify bilirubin levels. The reagent is prepared by the user and loaded into a Beckman Coulter User-Defined Cartridge for use on the SYNCHRON® instrument platform. The device is intended for clinical laboratory use by trained personnel. The output, a total bilirubin concentration value, is used by clinicians to aid in the diagnosis and management of liver diseases such as hepatitis, cirrhosis, and biliary obstruction. By providing accurate bilirubin measurements, the device assists in assessing liver function and monitoring patient metabolic status.

Clinical Evidence

Bench testing only. Performance validated via precision studies (n=80 per sample, total imprecision CV 0.6-2.4%), linearity (0-25 mg/dL, r=1), and analytical sensitivity (0.2 mg/dL). Method comparison against predicate on Synchron LX (n=70, y=1.031x+0.016, r=0.9997) and CX (n=70, y=1.004x+0.004, r=0.9997) platforms. Matrix comparison (serum vs. EDTA plasma) showed high correlation (n=58, r=0.999). Interference testing performed for hemoglobin and lipemia.

Technological Characteristics

Enzymatic colorimetric assay. Reagent kit for use on SYNCHRON® automated chemistry analyzers. Analytical range: 0.2-25 mg/dL. Wavelengths: 470 nm and 520 nm. Sample type: human serum and plasma. User-defined application on existing clinical chemistry platform.

Indications for Use

Indicated for the in vitro diagnostic determination of total bilirubin in human serum and plasma. Used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis, cirrhosis, and biliary obstruction.

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

• Dri-STAT® Enzymatic Bilirubin Reagent (K843174)
• SYNCHRON® Systems Bilirubin Calibrator (K791141)

Submission Summary (Full Text)

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# DEC 16 2005

Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090

# 510(k) Summary Dri-STAT® Enzymatic Bilirubin Reagent

### 1.0 Submitted By:

Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

# 2.0 Date Submitted:

November 1, 2005

## 3.0 Device Name(s):

#### 3.1 Proprietary Names

Dri-STAT® Enzymatic Bilirubin Reagent SYNCHRON® Systems Bilirubin Calibrator

#### 3.2 Classification Name

Bilirubin (total or direct) test system (21 CFR § 862.1110) Calibrator (21 CFR § 862.1150)

#### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|----------------------------------------------|-----------------------------------------------|----------------------------|------------------|
| Dri-STAT®<br>Enzymatic Bilirubin<br>Reagent | Dri-STAT®<br>Enzymatic Bilirubin<br>Reagent | Beckman<br>Coulter, Inc. * | K843174 |
| SYNCHRON®<br>Systems Bilirubin<br>Calibrator | SYNCHRON®<br>Systems Bilirubin<br>Calibrator | Beckman<br>Coulter, Inc.* | K791141 |

*Beckman Coulter, Inc., Brea, CA

SSE1

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Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090

#### Description: 5.0

The Dri-STAT® Enzymatic Bilirubin Reagent Enzymatic Bilirubin may be used The Dir-OTAT® Enzymation Billians in conjunction with the SYNCHRON® on the family of Oynomen Cystom ragent kit contains two reagent bottles that Systems Billirabili CallBraterferred into a Beckman Coulter User-Define Cartridge

### Intended Use: 6.0

Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic Systems Billirubin Sullirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

# Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| | <b>Similarities</b> | |
|----------------|----------------------|--------------------------------------------------------------------------------|
| TBE<br>Reagent | Intended Use | Same as Beckman Coulter |
| | Methodology | Dri-STAT® Enzymatic Bilirubin<br>Reagent,<br>Enzymatic Bilirubin on Cobas Fara |
| | Reactive Ingredients | |
| | Sample Types | |
| | Shelf Life | |
| | Reaction Type | |
| | Calibrator | |
| | <b>Differences</b> | |
| | Instrument Platforms | SYNCHRON® Systems<br>Vs<br>Cobas Fara |
| | Analytical Range | Up through 35 mg/dL on predicate<br>0.2-25 mg/dL on candidate |
| | Reference Intervals | 0.1-1.0 mg/dL on predicate<br>0.3-1.2 mg/dL per literature |
| | Wavelength | 465 nm on predicate<br>470 and 520 nm on candidate |
| | Reaction Volumes | 0.05; 1.00; 0.08 mL on predicate<br>10; 200; 16 µL on candidate |

SSE2

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# Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in moung of Substantial oquivalence is demonstrated through method comparison, linearity, and imprecision experiments.

| Candidate<br>Method | Sample<br>Type | Slope | Inter-<br>cept | R | n | Predicate Method |
|-----------------------------------------------------|----------------|-------|----------------|--------|----|---------------------------------------------------------------------|
| Dri-STAT<br>TBE Reagent<br>On Synchron<br>LX System | Serum | 1.031 | 0.016 | 0.9997 | 70 | Beckman Coulter<br>Dri-STAT<br>Enzymatic Bilirubin<br>on Cobas Fara |
| Dri-STAT<br>TBE Reagent<br>On Synchron<br>CX System | Serum | 1.004 | 0.004 | 0.9997 | 70 | Beckman Coulter<br>Dri-STAT<br>Enzymatic Bilirubin<br>on Cobas Fara |

Dri-STAT Enzymatic Bilirubin Method Comparison Study Results__________________________________________________________________________________________________________________

Dri-STAT Enzymatic Bilirubin Estimated Imprecision

| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N | | |
|------------------------|--------------|--------------|-------|----|--|--|
| Within-Run Imprecision | | | | | | |
| Serum Control 1 | 0.7 | 0.03 | 4.8 | 80 | | |
| Serum Control 2 | 4.0 | 0.05 | 1.1 | 80 | | |
| Serum Control 3 | 7.3 | 0.08 | 1.1 | 80 | | |
| Human Pool | 19.7 | 0.12 | 0.6 | 80 | | |
| Total Imprecision | | | | | | |
| Serum Control 1 | 0.7 | 0.03 | 4.8 | 80 | | |
| Serum Control 2 | 4.0 | 0.06 | 1.4 | 80 | | |
| Serum Control 3 | 7.3 | 0.11 | 1.5 | 80 | | |
| Human Pool | 19.7 | 0.47 | 2.4 | 80 | | |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

SSE3

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# DEC 16 2005

Ms. Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. Brea, CA 92822

k053090 Re:

Trade/Device Name: Dri- STAT® Enzymatic Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: JFM Dated: November 1, 2005 Received: November 2, 2005

Dear Ms. Hirumi:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to 10gm) the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costiletter (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, there's or visions of the Act include requirements for annual registration, listing of general controle profice, 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to bach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 that I Dri has intact a and regulations administered by other Federal agencies. You must or any I cutral statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing pactice 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) I mis letter will anow you to ough finding of substantial equivalence of your device to a legally promation in the 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 you coons 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 Four may 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 Gutz

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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Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090

# Indications for Use

510(k) Number (if known): K053090

Device Name: Dri-STAT® Enzymatic Bilirubin Reagent

Indications For Use:

Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Dri-STAT Enzymatic Billrabili Reagend, in the in vitro diagnostic Systemination of total bilirubin in human serum and plasma as a User Defined determination on SYNCHRON® Systems.

Measurements of total bilirubin in serum and plasma are used in the diagnosis Measurements of total Bhilary obstruction, hepatitis and cirrhosis

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Catharina

Office of In Vitro Diagnostic Device
Evaluation and Safety
(k) K053090

File: TBE RSP1_final.doc

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