JAS AMYLASE LIQUID REAGENT by JAS Diagnostics, Inc.

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Amylase Reagent" device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The letter primarily:

Confirms that the device is substantially equivalent to a legally marketed predicate device.
Outlines the regulatory requirements for the device.
Grants permission to market the device.
Provides contact information for regulatory inquiries.

The "Indications for Use" section (Page 2 of the original document) states: "Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers. Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas)."

However, no specific performance metrics like sensitivity, specificity, accuracy, precision, or recovery are mentioned, nor is there any description of a study conducted to demonstrate these. Therefore, I cannot extract the requested information regarding acceptance criteria or a study from this document.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

FEB 2 8 2002

Re: K020282

Trade/Device Name: Amylase Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System Regulatory Class: Class II Product Code: JFJ Dated: January 7, 2002 Received: January 28, 2002

Dear Mr. Johnston:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Joase contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

510(k) Number (if known): __ Ko20282 Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:

Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers.

Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cooper
(Division Sign-Off)
SSA
2/21/02

Division of Clinical Laboratory Devices

282

Prescription Use _v (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1070 Amylase test system.

(a)
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).(b)
Classification. Class II.