SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100

K082251 · Beckman Coulter, Inc. · DCF · Apr 8, 2009 · Immunology

Device Facts

• Record ID: K082251
• Device Name: SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
• Applicant: Beckman Coulter, Inc.
• Product Code: DCF · Immunology
• Decision Date: Apr 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for the quantitative determination of albumin (MA) concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.

Device Story

The SYNCHRON Systems Microalbumin (MA) Reagent is an in vitro diagnostic reagent used on SYNCHRON CX systems to measure albumin concentration in human urine. The device utilizes a turbidimetric method where albumin in the urine sample reacts with a goat anti-human albumin polyclonal antibody to form insoluble antigen-antibody complexes. The system automatically proportions one part sample to 24 parts reagent into a cuvette and monitors the change in absorbance at 380 nm. This absorbance change is proportional to the albumin concentration, which the system calculates using a non-linear calibration curve. The device is intended for use in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing kidney dysfunction by identifying elevated albumin levels in urine.

Clinical Evidence

No clinical data. Analytical performance demonstrated via bench testing on the CX4 CE system. Precision studies (N=80) showed total CVs ranging from 1.5% to 16.3%. Linearity confirmed across 0.2-30 mg/dL (R²=0.9997). Method comparison against predicate (N=111) yielded Y = 0.990X - 0.11 (r=0.987). Interference testing confirmed no significant interference from common substances (ascorbic acid, creatinine, glucose, etc.). LoB < 0.1 mg/dL; LoD < 0.2 mg/dL.

Technological Characteristics

Turbidimetric immunoassay; goat anti-human albumin polyclonal antibody; phosphate buffer with PEG; 380 nm absorbance detection; non-linear calibration curve; automated sample/reagent proportioning (1:24 ratio).

Indications for Use

Indicated for the quantitative determination of albumin concentration in human urine to aid in the diagnosis of kidney dysfunction. No specific age or gender restrictions provided.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Predicate Devices

• IMMAGE Immunochemistry Systems Microalbumin (MA) Reagent (K965035)

Submission Summary (Full Text)

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K082251

APR - 8 2009

Summary of Safety & Effectiveness SYNCHRON® Systems Microalbumin (MA) Reagent

#### 1.0 Submitted By:

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

#### Date Submitted: 2.0

August 7, 2008

#### Device Name(s): 3.0

## 3.1 Proprietary Names SYNCHRON® Systems Microalbumin (MA) Reagent

### 3.2 Classification Name Albumin immunological test system (21 CFR § 866.5040)

#### Predicate Device: 4.0

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|-----------------------------------------------|----------------------------------------------------------------|-------------------------|------------------|
| Synchron Systems<br>Microalbumin (MA) Reagent | IMMAGE Immunochemistry<br>Systems Microalbumin (MA)<br>Reagent | Beckman<br>Coulter, Inc | K965035 |

#### 5.0 Description:

Synchron Systems Microalbumin (MA) reagent is intended for the quantitative determination of albumin in urine. MA reagent is used to measure the albumin concentration by a turbidimetric method. In the reaction, albumin combines with specific antibody to form insoluble antigen-antibody complexes. The Synchron System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 24 parts reagent. The system monitors the change in absorbance at 380 nanometers. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the system to calculate and express albumin concentration based upon a non-linear calibration curve.

#### 6.0 Intended Use:

MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for the quantitative determination of albumin (MA) concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.

Beckman Coulter, Inc., Section 510(k) Notification Page 1 of 2 SYNCHRON® Systems Microalbumin (MA) SYNCHRON® Systems Microalbumin (MA) Reagent, Revised SYN MA 510K_Summary 04.07.09 no LX.doc August, 2008

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#### 7.0 Comparison to Predicate(s):

| | Similarities | |
|------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Synchron<br>Microalbumin<br>(MA) Reagent | Intended Use | Same |
| | Antibody | Goat anti-human albumin polyclonal Ab.<br>Same as Immage MA Reagent |
| | Buffer | Phosphate buffer with PEG |
| | Single point<br>adjusted<br>Calibration | MA on LX and DxC platforms and IMMAGE MA<br>use single point adjusted non-linear calibration. |
| | Differences | |
| Synchron<br>Microalbumin<br>(MA) Reagent | Initial measuring<br>range | Immage: 0.2 - 4.0 mg/dL<br>Synchron Systems: 0.2 - 30 mg/dL |
| | Extended<br>measuring range | Immage: 4.0 - 864.0 mg/dL<br>(achieved via on-line dilutions)<br>Synchron Systems: 24 - 97 mg/dL<br>(achieved via smaller sample size) |
| | Calibration | MA on Sychron CX systems uses 6 level non-<br>linear calibration curve. |

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

#### 8.0 Summary of Performance Data:

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

Method Comparison Study Results

| Candidate | Slope | Intercept | R | N | Predicate Method |
|---------------------------------------------------------------------------|-------|-----------|-------|-----|----------------------------------------|
| CX Systems<br>Synchron Microalbumin<br>(MA) Reagent<br>(0.4 to 26.1 mg/L) | 0.990 | -0.11 | 0.987 | 111 | IMMAGE<br>Microalbumin (MA)<br>Reagent |

# SYNCHRON CX Systems Precision Study Results

| Sample | Mean<br>(mg/dL) | S.D.<br>(mg/dL) | %C.V. | N |
|------------------------|-----------------|-----------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.8 | 0.08 | 9.7 | 80 |
| Level 2 | 3.0 | 0.14 | 4.5 | 80 |
| Level 3 | 40.1 | 0.42 | 1.0 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.8 | 0.13 | 16.3 | 80 |
| Level 2 | 3.0 | 0.23 | 7.5 | 80 |
| Level 3 | 40.1 | 0.59 | 1.5 | 80 |

Beckman Coulter, Inc., Section 510(k) Notification Page 2 of 2 SYNCHRON® Systems Microalbumin (MA) SYNCHRON® Systems Microalbumin (MA) Reagent, Revised SYN MA 510K_Summary 04.07.09 no LX.doc

August, 2008

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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 and Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Beckman Coulter Inc. c/o Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200, South Kraemer Blvd W-110 Brea, CA 92822-8000

APR - 8 2009

k082251 Re:

Trade/Device Name: SYNCHRON Systems MicroAlbumin (MA) Reagent Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: March 03, 2009 Received: March 04, 2009

Dear Ms. Boyajian:

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/dsma/dsmamain.html.

Sincerely yours,

Coy. C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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# Indication for Use

510(k) Number (if known): K082251

Device Name: SYNCHRON® Systems Microalbumin (MA) Reagent

Indication For Use:

MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082251