DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT

{0}------------------------------------------------ Premarket Notification - Diazyme Laboratories Diazyme Laboratories Division, General Atomics Image /page/0/Picture/1 description: The image shows the word "DIAZYME" in bold, block letters. Above the word is a four-pointed star-like symbol. The symbol is composed of four diamond shapes arranged around a central point. Submitter's name: OCT 2 9 2004 K042193 # Summary | Submitter's address: | 3550 General Atomics Court<br>San Diego, CA 92121 | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone: | 858-455-4761 | | Fax: | 858-455-4750 | | Name of Contact Person: | Chong Yuan, Ph.D.<br>Diazyme Laboratories Division<br>General Atomics<br>3550 General Atomics Court<br>San Diego, CA 92121<br>Phone: 858-455-4761<br>Fax: 858-455-4750 | | Date the summary was prepared: | July 7, 2004 | | Name of the device: | Glycated Serum Protein Enzymatic Assay | | Trade Name: | Diazyme Glycated Serum Protein Enzymatic Assay | | Common/Usual Name: | Enzymatic Assay, Fructosamine | | Classification Name: | Glycosylated Hemoglobin Assay (Per 21CFR section 862.3560) | ### Predicate Device: Device Class: The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Randox Fructosamine (K023763) manufactured by Randox Laboratories, Ltd., Antrim, UK. #### Description of the devices II Existing methods for the assay of glycated serum proteins or fructosamine such as furosine (HPLC), affinity chromatography, thiobarbituric acid (TBA) and nitroblue tetrazolium (NBT) are time consuming, difficult to automate and/or lack of specificity. Enzymatic assay of fructosamine is proven to be not only more specific and more accurate but also more user friendly for use in automated analyzers. Diazyme's glycated serum protein (Dia-GSPTM) assay is a specific enzymatic method for direct determination of fructosamine in serum. The assay utilizes Diazyme's proprietary frucosyl amine-oxygen oxidoreductase (fructosaminase™) to specifically react with the glycated amino acid substrates generated by on-line digestion of serum sample proteins with Proteinases. Liberation of hydrogen peroxide from the fructosaminase™ reaction allows a colorimeter determination of the amount of glycated protein through a coupled reaction with peroxidase. {1}------------------------------------------------ #### Intended Use of the Device: Diazyme Glycated Serum Protein Enzymatic Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator, are intended for the quantitative determination of glycated serum proteins (fructosamine) in serum. #### Performance Characteristics Diazyme's Glycated Serum Protein enzymatic assay is a two reagent (R1 and R2) based end point assay system. The results are obtained in 10 min by measuring absorbance at 550 mm. No off line pretreatment is needed. The assay has a wide measuring range from 0 to 1354 umo//L. The assay offers excellent precision as shown in the table below: | | 280 µmol/L | 586 µmol/L | |-----------------------|------------|------------| | Inter-assay Precision | CV%=1.74 | CV%=1.75 | | Total Precision | CV%=2.87 | CV%=2.94 | Diazyme's Glycated Serum Protein Enzymatic assay has good correlation with Randox Fructosamine assay (correlation coefficient of 0.98). We have conducted interference study by spiking the substances to be tested to the pooled human sera and found little interference at the indicated concentrations | Interference | Concentration | |---------------|---------------| | Uric Acid | 2 mM | | Haemoglobin | 200 mg/dl | | Glucose | 133 mM | | Triglyceride | 2000 mg/dl | | Ascorbic Acid | 0.230 mM | | Bilirubin | 20 mg/dl | Conclusion: Comparison analysis presented in the 510K submission for this device in the comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's Glycated Serum Protein Enzymatic assay has excellent accuracy and is safe and effective. There is no significant deviation between the results obtained by Diazyme's Glycated Serum Protein Enzymatic assay and legally marketed predicate Randox Fructosamine when testing clinical patient serum samples. Therefore, Diazyme's Glycated Serum Protein Enzymatic assay is substantially similar to the commercially available products to measure glycated serum proteins in human serum samples. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with their arms raised. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 2 9 2004 Chong Yuan, Ph.D. Managing Director Diazyme Laboratories Div. of General Atomics 3550 General Atomics Ct. San Diego. CA 92121 Re: k042193 > Trade/Device Name: Diazyme Glycated Serum Protein Enzymatic Assay Kit Diazyme Glycated Serum Controls Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JJX Dated: July 14, 2004 Received: August 12, 2004 Dear Dr. Yuan: 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). {3}------------------------------------------------ #### 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Jean M. Cooper, U.S. D.V.M. Tean 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 {4}------------------------------------------------ ## Indications for Use K042193 510(k) Number (if known): Device Name: Diazyme Glycated Serum Protein Enzymatic Assay Kit Indications for Use: Diazyme Glycated Serum Protein Enzymatic Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator, are intended for the quantitative determination of glycated serum proteins (fructosamine) in serum. The measurement of glycated serum proteins (fructosamine) is useful for monitoring diabetic patients. Diazyme Glycated Serum Protein Enzymatic Assay Kit contains a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples. Diazyme Glycated Serum Protein Enzymatic Assay has controls for normal glycated serum protein level and abnormal glycated serum protein level. The controls are used as reference samples for checking the functionality of the Diazyme Glycated Serum Protein Enzymatic Assay. Prescription Use _ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and 510(k) K0421.93