SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607

K091846 · Beckman Coulter, Inc. · JFJ · Oct 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091846
• Device Name: SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
• Applicant: Beckman Coulter, Inc.
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine. Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.

Device Story

AMY7 reagent is an in vitro diagnostic reagent used on SYNCHRON LX, UniCel DxC 600/800, and SYNCHRON CX PRO clinical systems. The device measures amylase activity in human serum, plasma, or urine samples via an enzymatic rate method. The system monitors absorbance changes at 410 nm; the rate of change is directly proportional to amylase activity. The clinical system calculates and reports total amylase activity. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing and managing pancreatitis.

Clinical Evidence

Bench testing only. Performance demonstrated through method comparison studies (N=87 for serum/plasma, N=78 for urine) against the predicate device, showing high correlation (R > 0.999). Imprecision studies (N=80 per sample level) conducted on CX7 PRO and DxC 600 platforms showed within-run and total imprecision (%CV) ranging from 0.5% to 5.1% across serum, plasma, and urine samples.

Technological Characteristics

Enzymatic rate method; photometric detection at 410 nm. Reagent kit consists of two 200-test cartridges. Designed for automated clinical chemistry analyzers (SYNCHRON LX, UniCel DxC, SYNCHRON CX PRO).

Indications for Use

Indicated for quantitative determination of total amylase activity in human serum, plasma, or urine to aid in the diagnosis and treatment of pancreatitis.

Regulatory Classification

Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Predicate Devices

• Amylase EPS Reagent (K070064)

Submission Summary (Full Text)

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K091846

# Summary of Safety & Effectiveness SYNCHRON® Systems G7 Amylase (AMY7) 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]

OCT 1 6 2009

#### 2.0 Date Submitted:

June 19, 2009

#### 3.0 Device Name(s):

### 3.1 Proprietary Names SYNCHRON® Systems G7 Amylase (AMY7) Reagent

#### 3.2 Classification Name

Amylase test system (21 CFR § 862.1070)

#### 4.0 Predicate Device :

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|-----------------------------------------------|---------------------|-----------------------------------|------------------|
| SYNCHRON Systems G7<br>Amylase (AMY7) Reagent | Amylase EPS Reagent | Thermo Fisher<br>Scientific, Inc. | K070064 |

#### 5.0 Description:

AMY7 reagent is used to measure the amylase activity by an enzymatic rate method. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the activity of AMY7 in the sample and is used by the System to calculate and express the total AMY7 activity.

The SYNCHRON G7 Amylase (AMY7) Reagent is designed for optimal performance on the SYNCHRON LX®, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges.

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#### 6.0 Intended Use:

AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine.

Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.

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

The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary and the G7 Amylase (AMY7) Reagent.

| | Similarities | | |
|--------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| SYNCHRON<br>Systems G7<br>Amylase<br>(AMY7)<br>Reagent | Intended Use | Same | |
| | Sample Types | Same | |
| | Instrument Platforms | Same | |
| | Primary Detection<br>Wavelength | Same | |
| | Reaction Type<br>(Methodology) | Same | |
| | Reagent Volume | AMY7 Reagent: Compartment A: 175 µl<br>Compartment B: 35 µl<br>EPS-G7 Reagent: Compartment A: 175 µl<br>Compartment B: 35 µl | |
| | Differences | | |
| SYNCHRON<br>Systems G7<br>Amylase<br>(AMY7)<br>Reagent | Analytical range<br>(Serum/Plasma/ Urine) | AMY7 Reagent: 8 – 1200 U/L on CX PRO<br>5 – 1200 U/L on LX/DxC<br>1000 – 2000 U/L ORDAC<br>EPS-G7 Reagent: 4 – 1800 U/L on CX<br>4 – 2000 U/L on LX/DxC | |
| | Open reagent stability | AMY7 Reagent: 21 days<br>EPS-G7 Reagent: 35 days | |
| | Sample volume | AMY7 Reagent: 7 µl<br>3 µl ORDAC<br>EPS-G7 Reagent: 7 µl | |

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#### 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.

| Candidate | Platform | Slope | Intercept | R | N | Predicate<br>Method |
|------------------------------|----------|-------|-----------|--------|----|--------------------------------|
| G7 Amylase<br>(AMY7) Reagent | CX7 PRO | 1.150 | -4.089 | 0.9999 | 87 | Thermo Fisher<br>Amylase EPS - |
| | DxC 600 | 1.081 | -3.364 | 1.0000 | 83 | G7 Reagent |

## Serum Method Comparison Summary

## Urine Method Comparison Summary

| Candidate | Platform | Slope | Intercept | R | N | Predicate<br>Method |
|------------------------------|----------|-------|-----------|--------|----|-----------------------------|
| G7 Amylase<br>(AMY7) Reagent | CX7 PRO | 1.109 | -2.086 | 0.9997 | 78 | Thermo Fisher |
| | DxC 600 | 1.039 | -0.703 | 0.9997 | 78 | Amylase EPS –<br>G7 Reagent |

. . . . . . . . . . . . . . . . . . . . . . . . . . . .

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# SYNCHRON Systems G7 Amylase (AMY7) Reagent Precision Study Results

| Sample | Mean<br>(U/L) | S.D.<br>(U/L) | %C.V. | N | |
|------------------------|---------------|---------------|-------|-----|----|
| Within-Run Imprecision | | | | | |
| Serum/Plasma | Level 1 | 75.8 | 1.3 | 1.7 | 80 |
| Serum/Plasma | Level 2 | 899.5 | 4.7 | 0.5 | 80 |
| Serum/Plasma | (ORDAC) | 1762.0 | 12.9 | 0.7 | 80 |
| Urine | Level 1 | 54.9 | 1.3 | 2.4 | 80 |
| Urine | Level 2 | 164.6 | 1.7 | 1.1 | 80 |
| Urine | (ORDAC) | 1182.9 | 11.8 | 1.0 | 80 |
| Total Imprecision | | | | | |
| Serum/Plasma | Level 1 | 75.8 | 1.4 | 1.8 | 80 |
| Serum/Plasma | Level 2 | 899.5 | 8.2 | 0.9 | 80 |
| Serum/Plasma | (ORDAC) | 1762.0 | 34.9 | 2.0 | 80 |
| Urine | Level 1 | 54.9 | 1.4 | 2.5 | 80 |
| Urine | Level 2 | 164.6 | 1.9 | 1.2 | 80 |
| Urine | (ORDAC) | 1182.9 | 60.4 | 5.1 | 80 |

Precision Study Results on SYNCHRON CX7 PRO Clinical System

Precision Study Results on UniCel DxC 600 SYNCHRON Clinical System

| Sample | Mean<br>(U/L) | S.D.<br>(U/L) | %C.V. | N |
|------------------------|---------------|---------------|-------|----|
| Within-Run Imprecision | | | | |
| Serum/Plasma Level 1 | 78.7 | 1.0 | 1.3 | 80 |
| Serum/Plasma Level 2 | 913.6 | 4.5 | 0.5 | 80 |
| Serum/Plasma (ORDAC) | 1775.4 | 8.7 | 0.5 | 80 |
| Urine Level 1 | 56.5 | 0.7 | 1.2 | 80 |
| Urine Level 2 | 168.4 | 0.9 | 0.5 | 80 |
| Urine (ORDAC) | 1181.0 | 6.0 | 0.5 | 80 |
| Total Imprecision | | | | |
| Serum/Plasma Level 1 | 78.7 | 0.8 | 1.1 | 80 |
| Serum/Plasma Level 2 | 913.6 | 5.5 | 0.6 | 80 |
| Serum/Plasma (ORDAC) | 1775.4 | 11.0 | 0.6 | 80 |
| Urine Level 1 | 56.5 | 0.7 | 1.2 | 80 |
| Urine Level 2 | 168.4 | 1.1 | 0.7 | 80 |
| Urine (ORDAC) | 1181.0 | 55.5 | 4.7 | 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 CF R 807.92.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Beckman Coulter. Inc. ATTN: Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200 South Kraemer Blvd. W-110 Brea, CA 92822

OCT 1 & 2009

Re: k091846

> Trade/Device Name: Synchron® Systems G7 Amylase (AMY7) Reagent Regulation Number: 21 CFR §862.1070 Regulation Name: Amylase test system. Regulatory Class: Class II Product Code: JFJ Dated: September 11, 2009 Received: September 14, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

CA

Courtney C. Harper, 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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# Indication for Use

510(k) Number: k091846

Device Name: SYNCHRON® Systems G7 Amylase (AMY7) Reagent

Indication For Use:

AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine.

Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.

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)

y

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

510(k) K091846

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