SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT

K013978 · Beckman Coulter, Inc. · JFJ · Jan 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013978
• Device Name: SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

Pancreatic Amylase (PAM) Reagent is intended for the quantitative determination of pancreas-specific amylase activity in human serum, plasma or urine on SYNCHRON Systems.

Device Story

Liquid, ready-to-use reagent kit for quantitative determination of pancreas-specific amylase activity; utilizes immuno-inhibition method. Designed for use on Beckman Coulter SYNCHRON CX and LX clinical chemistry systems. Operated by laboratory personnel in clinical settings. Reagent reacts with patient samples (serum, plasma, urine) to measure amylase activity; results provided to clinicians to assist in diagnosis and treatment of pancreatitis.

Clinical Evidence

Bench testing only. Method comparison study performed between subject PAM reagent and predicate PAMY reagent on SYNCHRON LX systems. Precision studies conducted with 80 replicates per sample type (serum and urine controls) across varying concentration levels; within-run %C.V. ranged from 0.7% to 1.3%, and total imprecision %C.V. ranged from 1.1% to 4.3%.

Technological Characteristics

Liquid, ready-to-use reagent; immuno-inhibition assay principle. Designed for automated clinical chemistry analyzers (SYNCHRON CX/LX). Storage at +2°C to +8°C. Shelf life and stability parameters defined for on-instrument use (30 days).

Indications for Use

Indicated for the quantitative determination of pancreas-specific 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

• SYNCHRON CX® Systems Pancreatic Amylase (PAMY) Reagent (K934293)

Submission Summary (Full Text)

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JAN 1 5 2002

# K013978 510(k) Summary SYNCHRON® Systems Pancreatic Amylase Reagent

## 1.0 Submitted By:

Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] Fax: [phone]

## 2.0 Date Submitted:

November 30, 2001

## 3.0 Device Name(s):

## 3.1 Proprietary Names

SYNCHRON® Systems Pancreatic Amylase Reagent

## 3.2 Classification Name

Amylase test system (21 CFR § 862.1070)

# 4.0 Predicate Device(s):

| Beckman Coulter | Predicate | Manufacturer | Docket<br>Number |
|----------------------------------------------------------|--------------------------------------------------------------|-----------------|------------------|
| SYNCHRON® Systems<br>Pancreatic Amylase<br>(PAM) Reagent | SYNCHRON CX® Systems<br>Pancreatic Amylase<br>(PAMY) Reagent | Beckman Coulter | K934293 |

## 5.0 Description:

Beckman Coulter's Pancreatic Amylase (PAM) Reagent is a liquid stable, ready-to-use reagent designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of pancreas-specific amylase activity in human serum, plasma, or urine. The reagent kit contains two 60-test cartridges.

## 6.0 Intended Use:

Pancreatic Amylase (PAM) Reagent is intended for the quantitative determination of pancreas-specific amylase activity in human serum, plasma or urine on SYNCHRON Systems.

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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## Comparison to Predicate(s): 7.0

| Assay | Aspect/Characteristic | Comments |
|-------------------------------------|------------------------------------|-------------------------------------------------------------------------------------------|
| SIMILARITIES | | |
| SYNCHRON®<br>Systems PAM<br>Reagent | Intended use | Same as Beckman Coulter<br>SYNCHRON CX® PAMY Reagent |
| | Methodology | |
| | Antibody source (mouse) | |
| | Storage (+2°C to +8°C) | |
| | Shelf life | |
| | Sample type (serum, plasma, urine) | |
| | Sample size | |
| | Analytic range | |
| DIFFERENCES | | |
| | Reagent formulation | PAM: ready to use liquid reagent<br>PAMY: lyophilized components<br>requiring preparation |
| | Reagent volume per test | PAM: 240 μl |
| | | PAMY: 220 μl |
| | On-instrument stability | PAM: 30 days |
| | | PAMY: 14 days |
| | Instrument platforms | PAM: CX and LX |
| | | PAMY: CX only |

## 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 commercial distribution. Equivalence is demonstrated through method comparison and precision experiments that relate results obtained from the SYNCHRON Pancreatic Amylase (PAM) Assay to the Beckman Coulter's SYNCHRON CX Pancreatic Amylase (PAMY) Reagent.

Method Comparison Study Results*

| | | | 【【】【【】【】【【】【】【】【】【】【】【】【】【】【】【】【】【】【<br> | <br>છે ઊભ્તાસ<br>BA-66 -<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Accuration Controlling | . MENE REMERE R B | | | |
| Reagent<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>:<br>No. on . Mont a monta a super | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br> | <br>COLOR CONSULTION OF<br> | And Call And College of<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>OAMY Reager<br>---------- |

*Data shown was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON CX and LX Systems has been established by correlation analysis.

| Estimated SYNCHRON LX Systems PAM Imprecision | |
|-----------------------------------------------|--|
| | |

| Sample | Mean (U/L) | S.D. (U/L) | %C.V. | N |
|-------------------------|------------------------|------------|-------|----|
| | Within-Run Imprecision | | | |
| Serum Control 1 | 64 | 0.8 | 1.3 | 80 |
| Serum Control 2 | 410 | 3.3 | 0.8 | 80 |
| Serum Control 3 (ORDAC) | 772 | 8.3 | 1.1 | 80 |
| Urine Control 1 | 148 | 1.0 | 0.7 | 80 |
| | Total Imprecision | | | |
| Serum Control 1 | 64 | 2.7 | 4.3 | 80 |
| Serum Control 2 | 410 | 4.5 | 1.1 | 80 |
| Serum Control 3 (ORDAC) | 772 | 10.5 | 1.4 | 80 |
| Urine Control 1 | 148 | 1.9 | 1.3 | 80 |

The Summary of Safety and Effectiveness information for the SYNCHRON Systems Pancreatic Amylase Reagent is found in TAB 1 of this notice and is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and implementing regulation 21 CFR 807.92.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 5 2002

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-104 Box 8000 Brea, CA 92822-8000

Re: k013978

R015776
Trade/Device Name: SYNCHRON® Systems Pancreatic Amylase Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: November 30, 2001 Received: December 3, 2001

Dear Ms. Tang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becarent of the device is substantially equivalent (for the indications ferenced above and have actesinglegally marketed predicate devices marketed in interstate for use stated in the enclosed) to togals) to togals (1976) Device Amendments, or to comments from to may 20, 1978, are one and the provisions of the Federal Food, Drug, devices that have been receasines arquire approval of a premarket approval application (PMA). allu Cosmette Act (10t) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mainer of the Act include requirements for annual registration, listing of general connolis provisions of visitions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (600 wor of als. Existing major regulations affecting your device can may be subject to sach adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc actives that I Dr usean that your device complies with other requirements of the Act that I DA has made a color regulations administered by other Federal agencies. You must of any I coloral statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of IT at 6077, adomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis lotter will and to your ding of substantial equivalence of your device to a legally marketed nouthoution. The I Dr in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (201) 59 m 45 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of 1

510(k) Number (if known): K013978

SYNCHRON® Systems Pancreatic Amylase Reagent Device Name:

Indications for Use:

Pancreatic Amylase (PAM) Reagent is intended for the quantitative Pancreatic Anytase (1744) Treather activity in human serum, determination "Of "Paneloaan Coulter's SYNCHRON Systems by an immuno-Measurement of pancreatic amylase is useful in the inhibition method. diagnosis and treatment of pancreatitis.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K013978

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

OR

Over-the-Counter Use Optional Format 1-2-96