SPOTCHEM II CREATININE, AMYLASE & ALP TESTS

K050652 · Arkray, Inc. · CGX · Apr 6, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050652
• Device Name: SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
• Applicant: Arkray, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Apr 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The SPOTCHEM II Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The SPOTCHEM II Amylase test is intended to measure amylase activity in serum, plasma, and whole blood. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The SPOTCHEM II ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Device Story

SpotChem II assays (Creatinine, Amylase, ALP) are in vitro diagnostic reagents for use on SpotChem EZ Analyzer. Device consists of plastic strip with multi-layered test field (sample-retention, reagent, support layers). User applies serum, plasma, or whole blood to test field; sample permeates reagent layer to initiate colorimetric reaction. Analyzer uses reflectance spectrophotometry (550 nm for Creatinine; 405 nm for Amylase/ALP) to measure color intensity/rate. Output is quantitative analyte concentration/activity. Used in clinical settings by healthcare professionals. Results assist clinicians in diagnosing/monitoring renal, pancreatic, liver, bone, parathyroid, and intestinal conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics typical for in vitro diagnostic test systems.

Technological Characteristics

Plastic reagent strip with multi-layered test field (sample-retention, reagent, support). Principle: reflectance spectrophotometry. Energy source: SpotChem EZ Analyzer. Connectivity: magnetic card for lot-specific calibration data. Sterilization: not specified. Software: embedded analyzer firmware for calculation and data processing.

Indications for Use

Indicated for patients requiring measurement of creatinine, amylase, or alkaline phosphatase (ALP) in serum, plasma, or whole blood for the diagnosis and treatment of renal, pancreatic, liver, bone, parathyroid, or intestinal diseases.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

2005 APR 6

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Arkray, Inc. c/o Ms. Helen Landicho, RAC Director of Regulatory Affairs Polmedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567

Re: k050652

Trade/Device Name: Arkray SPOTCHEM II Creatinine, Amylase and ALP Tests Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX, CIJ, CJE Dated: March 9, 2005 Received: March 15, 2005

Dear Ms. Landicho:

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 10 race waver to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimores 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 i feast be active a and a determination that your device complies with other requirements of the Act than 127 had intatutes and regulations administered by other Federal agencies. You must or any I vith 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 CFR Part 807), tabeling the quality systems (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

## Page 2 –

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

Sincerely yours,

Sean M. Cooper, MS, DUM

Jean M. Cooper, MS, 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Arkray SPOTCHEM II Creatinine, Amylase, and ALP Tests

Indications For Use:

The SPOTCHEM II Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The SPOTCHEM II Amylase test is intended to measure amylase activity in serum, plasma, and whole blood. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The SPOTCHEM II ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

O:
De Diagnostic
-tary

Page 1 of 1