URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)

{0} K970277 # 510(k) SUMMARY Astoria-Pacific Uridyltransferase 50-Hour Reagent Kit # 510(K) SUMMARY DEC 11 1997 # IDENTIFICATION Submitter's Name: Raymond L. Pavitt, President Astoria-Pacific, Inc. Address: 14600 SE 82nd Drive Clackamas, OR 97015-0830, USA Telephone: 503-657-3010 FAX: 503-655-7367 Contact Person: Lester B. Garrison, Diagnostics Manager Date Summary Prepared: August 4, 1997 # NAME OF DEVICE Proprietary Name: Uridyltransferase (GALT) 50-Hour Reagent Kit Common Name: Uridyltransferase (GALT) Test System Classification Name: 862.1315 Galactose-1-Phosphate Uridyltransferase Test System # LEGALLY MARKETED DEVICE EQUIVALENT TO PROPOSED DEVICE The Uridyltransferase 50-Hour Reagent Kit is substantially equivalent to a legally marketed predicate device, Sigma Galactose-1-Phosphate Uridyltransferase (Gal-PUT) Deficiency Screen. # DESCRIPTION OF PROPOSED DEVICE The proposed device, Uridyltransferase 50-Hour Reagent Kit, is a set of reagents to be used with the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System for the quantitative determination of the enzyme galactose-1-phosphate uridyltransferase (UT) in whole blood saturated filter paper disks. The amount of uridyltransferase activity is determined by measuring the fluorescent compound produced in the reaction of UT with galactose and UDP Glucose, followed by NADP reduction at 37°C. The excitation wavelength of the reaction product is 450 nm, and its emission is measured at 550 nm. The method is specific for uridyltransferase. The method is designed for mass screening, with enough reagents in each 50-Hour Reagent Kit for 1 week plus start-up (50 hours total) of run time. It is packaged to reduce storage space and to require a minimum of time to prepare. Each component is packaged with the correct weight to prepare the required volume of reagent. The standard is in a concentrated form, to permit easy dilution to prepare a standard curve. The materials provided and their components are listed below. {1} 510(k) SUMMARY Astoria-Pacific Uridyltransferase 50-Hour Reagent Kit REAGENTS | DESCRIPTION | Component | Concentration | Quantity | | --- | --- | --- | --- | | GALT Extraction Buffer | Succinate Buffer pH 5.2 | 0.8 mM | 1 Liter | | Recipient Diluent | Tris Buffer, pH 7.8 | 100 mM | 1 Liter | | | Triton X-100 | 0.5 mL/L | | | GALT Buffer Part A. | Tris Buffer, pH 7.8 | 100 mM | 5 x 150 mL | | | NADP | 1.3 mM | | | | Dithiothreitol | 1.0 mM | | | GALT Buffer Part B. | Magnesium | 0.6 mM | | | | EDTA | 0.1 mM | | | | Triton X-100 | 0.5 mL/L | | | PGluM Substrate Reagent | Glu-1-Phosphate | 10. mM | 10 mL | | GALT Substrate Reagent | Gal-1-Phosphate | 4.3 mM | 5 x 60 mL | | | UDPG | 0.5 mM | | | | G6PDH Yeast | 1.6 KU/L | | | | PGluM Rabbit Muscle | 0.8 KU/L | | | NADH Stock Standard | TEA Buffer, pH 9.0 | 50 mM | 2 x 50 mL | | | NADH | 50 μM | | ## INTENDED USE This Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit is for the qualitative determination of galactose-1-phosphate uridylyltransferase, EC 2.7.7.12 (GALT) activity in whole blood saturated filter paper disks (S&S 903 filter paper or equivalent), using the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System. Measurements of galactose-1-phosphate uridylyltransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT activity in infants. This method is not for monitoring purposes. ## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE DEVICE ## Similarities with Predicate Device The Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit is similar to a predicate device, Sigma Galactose-1-Phosphate Uridyltransferase (Gal-PUT) Deficiency Screen, having the same technological characteristics and intended use. Both are diagnostic reagent kits to be used for the qualitative, fluorometric determination of the enzyme uridylyltransferase in blood; both have the same chemical principles and reaction mechanism. {2} 510(k) SUMMARY Astoria-Pacific Uridyltransferase 50-Hour Reagent Kit The reactants and reactions are the same. Both devices use the same incubation temperature and a similar incubation time. ## Differences from Predicate Device While the method and reagents are similar for the proposed and predicate devices, there are minor differences. The Sigma device uses G6PD and PGluM from the sample for the reactions. The proposed device adds these enzymes to the reagent. The Sigma device requires manual reading of fluorescence; the API™ 300 SPOTCHECK® Analyzer reads the fluorescence automatically. There are also differences in the wavelengths of the excitation and emission filters. The proposed device designates 450 nm and 550 nm for the excitation and emission wavelengths, respectively; the Sigma device uses a broad band UV lamp for excitation and visual fluorometry for reading the emitted fluorescence. Because there is a broad bandpass of about 40 nm for the filters on the API™ 300 SPOTCHECK® Analyzer and the emitted fluorescent light is broad spectrum, this difference is not consequential. The API Uridyltransferase 50-Hour Reagent Kit contains a NADH standard for comparision of the fluorescence readings. The Sigma Gal-PUT Deficiency Screen test requires the user to prepare all reagents; in the Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit, the reagents are either pre-made or pre-weighed. The minor differences between the Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit and the Sigma Gal-PUT Deficiency Screen raise no questions of safety or efficacy. ## BRIEF DISCUSSION OF NONCLINICAL TESTS Because there is such a strong similarity between the Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit and the Sigma Gal-PUT Deficiency Screen, no nonclinical testing has been performed to demonstrate substantial equivalence. ## BRIEF DISCUSSION OF CLINICAL TESTS Clinical testing was performed on whole blood saturated filter paper disks. These tests include 27 specimens analyzed, of which 20 were normal neonatal blood samples and 7 were deficient samples from juveniles and adults. Results correlated well, as there were no false positives and no false negatives among any of the samples tested. ## CONCLUSIONS DRAWN FROM THE NONCLINICAL AND CLINICAL TESTS The clinical tests demonstrate that the proposed device, the Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit, is safe, effective and performs as well as a predicate device, as evidenced by the correlation of results obtained from clinical studies. ## OTHER INFORMATION No other information has been requested by FDA at this time. {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 11 1997 Lester B. Garrison Submission Correspondent Astoria-Pacific, Inc. 14600 S.E. 82nd Drive P.O. Box 830 Clackamas, Oregon 97015 Re: K970277 Uridyltransferase Test System Regulatory Class: II Product Code: KQP Dated: November 5, 1997 Received: November 6, 1997 Dear Mr. Garrison: 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 regulations. {4} 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 (770) 488-7655. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, 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 {5} Page ___ of ___ 510(k) Number (if known): K970277 Device Name: Undyltransferase 50-Hour Reagent Kit Indications For Use: October 8, 1997 Astoria-Pacific, Inc. Statement of Indications for use: This Astoria-Pacific SPOTCHECK® Uridyltransferase 50-Hour Reagent Kit is for the qualitative determination of galactose-1-phosphate uridyltransferase (EC 2.7.7.12) (GALT) activity in whole blood saturated filter paper disks, S&S 903 filter paper or equivalent, using the API™ 300 SPOTCHECK® Analyzer or the AFA-300 System. Measurements of galactose-1-phosphate uridyltransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT enzyme activity in infants. This method is not for monitoring purposes. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number OR Over-The-Counter Use (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number Prescription Use ☑ (Per 21 CFR 801.109) TOTAL P.08