AMYLASE EPS REAGENT

K070064 · Thermo Fisher Scientific · JFJ · May 22, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070064
• Device Name: AMYLASE EPS REAGENT
• Applicant: Thermo Fisher Scientific
• Product Code: JFJ · Clinical Chemistry
• Decision Date: May 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

The Amylase EPS reagent is used for the quantitative determination of α-Amylase (1,4- α-D-glucan glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX®/LX® Systems. α-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.

Device Story

Amylase EPS reagent is a two-part liquid enzymatic assay for quantitative determination of α-Amylase in human serum, plasma, or urine. Used on Beckman Coulter SYNCHRON CX/LX systems; operated by laboratory personnel. Principle: EPS-G7 substrate cleaved by α-amylase into fragments; fragments hydrolyzed by α-glucosidase to produce glucose and p-nitrophenoxide (pNP). Rate of pNP formation measured via increase in absorbance; proportional to α-amylase activity. Results assist clinicians in diagnosing acute pancreatitis. System calculates activity using a programmed factor traceable to IFCC reference method.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP-5A2 (20-day study, 40 runs). Linearity evaluated per CLSI EP-6A (0-2200 U/L range). Method comparison against predicate (n=111 serum/plasma pairs; n=106/99 urine pairs) showed high correlation (R > 0.99). Interference testing performed for hemoglobin, bilirubin, lipemia, glucose, and ascorbic acid. No clinical studies performed.

Technological Characteristics

Two-part liquid reagent. Reagent A: α-glucosidase, NaCl, MgCl2, CaCl2, buffer. Reagent B: EPS substrate, buffer. Sensing principle: enzymatic rate (absorbance increase). Connectivity: integrated with Beckman Coulter SYNCHRON CX/LX systems. Traceable to IFCC Amylase EPS reference method. Standards: CLSI EP-5A2, CLSI EP-6A.

Indications for Use

Indicated for quantitative determination of α-Amylase in human serum, plasma, or urine to aid in the diagnosis of acute pancreatitis. Prescription use only.

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 Ready Amylase reagent (k903309)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Thermo Fisher Scientific c/o Ms. Melita Lambiris Quality Assurance Manager 189-199 Browns Road Noble Park, Victoria, 3174 Australia

MAY 2 2 2007

Re: k070064 Trade/Device Name: Amylase EPS Reagent

Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System. Regulatory Class: Class II Product Code: JFJ Dated: April 14, 2007 Received: April 23, 2007

Dear Ms. Lambiris:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K070064

Amylase EPS Reagent Device Name:

Indications For Use:

The Amylase EPS Reagent is used for the quantitative (1,4-α-D-glucan determination of a-Amylase glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/ LX ® Systems.

a-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.

X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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