AMY

K981216 · Abbott Laboratories · JFJ · Jun 8, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981216
• Device Name: AMY
• Applicant: Abbott Laboratories
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Jun 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

The amylase assay is used for the quantitation of amylase in human serum, plasma, or urine.

Device Story

The Amylase assay is an in vitro diagnostic clinical chemistry test used to measure amylase activity in human serum, plasma, or urine samples. The assay utilizes a kinetic enzymatic method where amylase in the sample hydrolyzes 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNPG3) into 2-chloro-4-nitrophenol (CPNP) and other products. The rate of CPNP formation is measured via increased absorbance at 405 nm, which is directly proportional to the amylase activity in the sample. The assay is performed on the ALCYON Analyzer. Healthcare providers use the quantitative results to assist in the diagnosis and clinical management of pancreatitis. The device provides objective biochemical data to support clinical decision-making regarding pancreatic health.

Clinical Evidence

Bench testing only. Method comparison studies between the Amylase assay on the ALCYON Analyzer and the Roche Cobas Mira Plus system showed high correlation (serum: r=0.9791, slope=1.126, y-intercept=-18.427 U/L; urine: r=0.9702, slope=0.977, y-intercept=0.447 U/L). Precision studies (within-run, between-run, between-day) reported total %CVs ranging from 3.3% to 10.6% depending on sample type and control level. The assay is linear up to 2,500 U/L with a limit of quantitation of 4.268 U/L.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Principle: Kinetic enzymatic hydrolysis of CNPG3 substrate measured by absorbance at 405 nm. Form factor: Reagent-based assay for use on the ALCYON Analyzer. No software algorithm or connectivity details provided.

Indications for Use

Indicated for the quantitative determination of amylase 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

• Roche Cobas Mira Plus Automated Chemistry System Amylase assay (K903309)

Submission Summary (Full Text)

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JUN - 8 1999

K981216

# 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | April 2, 1998 |
|--------------------------------------------------|----------------|
| Device Trade or Proprietary Name: | Amy |
| Device Common/Usual Name or Classification Name: | Amylase |
| Classification Number/Class: | 75JFJ/Class II |

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 assigned 510(k) number is:

#### Test Description:

Amylase is an in vitro diagnostic assay for the quantitative determination of amylase in serum, plasma, or urine. The Amylase assay is a clinical chemistry assay. The amylase in the sample hydrolyzes the 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNPG3) to release 2-chloro-4-nitrophenol (CPNP) and form 2-chloro-4-nitrophenylα-D-maltoside (CNPG2), maltotriose (G3), and glucose (G). The rate of formation of the 2-chloro-4-nitrophenol is measured as an increase in the absorbance at 405 nm and is directly proportional to the activity of amylase present in the sample.

Amylase 510(k) April 2, 1998 AmylaE2.lwp

Section II Page 1

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#### Substantial Equivalence:

The Amylase assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Amylase assay (K903309) for serum, plasma, or urine applications.

These assavs vield similar Performance Characteristics.

Similarities to Roche:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of amylase in serum . or urine.
- Both assays yield similar clinical results. .

Differences to Roche:

- The Roche Amylase assay on the Cobas Mira Plus Automated System is not . intended for use with heparinized plasma.
#### Intended Use:

The amylase assay is used for the quantitation of amylase in human serum, plasma, or urine.

#### Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Amylase assay method comparison vielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Amylase assay for the serum and urine applications. For serum applications, the correlation coefficient = 0.9791. slope = 1.126, and Y-intercept = - 18.427 U/L. For urine applications, the correlation coefficient = 0.9702, slope = 0.977, and Y-intercept = 0.447 U/L. Precision studies were conducted using the Amylase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 3.3% and Level 2/Panel 112 is 3.7% for serum applications, and 10.6% for Level 1/Panel 131, and 4.4% for Level 2/Panel 132 for urine applications. The

Amylase 510(k) April 2, 1998 AmylaE2.lwp

Section II Page 2

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Amylase assay is linear up to 2,500 U/L. The limit of quantititation (sensitivity) of the Amylase assay is 4.268 U/L. These data demonstrate that the performance of the Amylase assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Amylase assay for the serum and urine applications.

### Conclusion:

The Amylase assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Amylase assay as demonstrated by results obtained in the studies.

Amylase 510(k) April 2, 1998 AmylaE2.lwp

Section II Page 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

8 1000 JUN

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re : K981216 Amylase Regulatory Class: II Product Code: JFJ Dated: April 2, 1998 Received: April 3, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 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, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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510(k) Number (if known): Jrg K/2 16

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Amylase assay is is used for the quantitation of amylase in serum, plasma, or urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

00000000

| (Division Sign-Off) | |
|-----------------------------------------------------------|---------|
| Division of Clinical Laboratory Devices<br>40(K) Number . | n981216 |

:

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

Concy rence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use ----------OR (Per 21 CFR 801.109) (Optional Format 1-2-96)

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510(k) Number (if known): Jrg K/2 16

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Amylase assay is is used for the quantitation of amylase in serum, plasma, or urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K981216 |
|---------------|---------|
|---------------|---------|

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)