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The SPOTCHECK® Neonatal Total Galactose Microplate Reagent Kit is for the quantitative determination of the concentration of Total Galactose (Gal) + galactose-1-phosphate (Gal-1-P)) in whole blood saturated filter paper disks, using a microplate absorbance reader or SPOTCHECK Pro. Measurements of Total Galactose are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for increased concentrations of Total Galactose, and not for monitoring purposes.

The SPOTCHECK Neonatal Total Galactose Microplate Reagent Kit is a galactose test system. It includes Extraction Solution, Enzyme Reagent, Coenzyme Reagent, Color Reagent, and Stock Standard. Total Galactose is measured colorimetrically following the completion of two enzyme assisted reactions and the color formation reaction. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a 96 well filtration microplate. Extraction solution is added and samples are eluted and incubated. The contents are filtered into a clean flat-bottom microplate. Enzyme Reagent and Coenzyme Reagent are added and the plate is incubated. Color Reagent is then added and the plate is incubated. The absorbance is measured on a microplate reader at a wavelength of 600 nm for the measurement channel and 750 nm for the reference channel. Results are expressed as mg of total galactose per dL of whole blood.

The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for decreased levels of GALT enzyme activity, and not for monitoring purposes. The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements. These devices are intended for use by trained, qualified laboratory personnel.

SPOTCHECK Neonatal GALT Microplate Reagent Kit - 60 Plate: Four enzyme mediated reactions are employed in the determination of GALT activity. GALT activity is determined by measuring the colored formazan produced by the addition of the color reagent to the incubated blood/substrate mixture. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a standard 96 well microplate. A buffered enzyme mixture is added to each well and the plate is incubated at 37 °C for 120 minutes on a plate shaker/incubator. Following incubation, an aliquot of the mixture from each well is transferred to the corresponding wells on a clean 96 well microplate. Color reagent is added to each well, the color is developed over the course of 10 minutes, and the absorbance of each sample is determined on the plate reader. A blank absorbance reading is made prior to the addition of the color reagent to correct for endogenous sample color. The color developed is proportional (1:1) to the GALT activity in the sample. A standard curve prepared from a stock NADH solution is used to quantitate the results. Results are expressed as units of GALT enzyme activity per gram of hemoglobin or U/g Hb. SPOTCHECK Pro: INSTRUMENT COMPONENTS: Tecan Freedom EVO and accessories necessary for assay.

The devices described herein are intended to be used with Astoria-Pacific's SPOTCHECK family of neonatal screening reagent kits. Assays currently offered on the system included Uridyltransferase (GALT), Biotinidase**, Total Galactose, Phenylalanine, G6PD, and Tyrosine. They are intended for use by qualified clinical laboratory professionals. ** Astoria-Pacific is not currently seeking FDA-clearance for Biotinidase on the SPOTCHECK Flow. The SPOTCHECK Flow system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are: - Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit - Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit - Phenylalanine, elevated concentration (Phenylketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit - Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit - Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes. The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are: - Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit - Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit - Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit - Phenylalanine, elevated concentration (Phenvlketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit - Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit - Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes. The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn error in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assay are: - Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes. The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are: - Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit - Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit - Phenylalanine, elevated concentration (Phenviketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit - Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit - Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit The system is intended for screening use only and is not intended for monitoring purposes.

The SPOTCHECK continuous flow analyzer consists of various devices that interact together to provide a complete in vitro diagnostic (IVD) instrument system for use with Astoria-Pacific's neonatal screening assays. The technology can be considered automated bench chemistry in which continuously flowing reagents are mixed with the sample, ultimately producing a detectable product that correlates to analyte concentration. Proper conditions for reactions are controlled by using a variety of techniques such as specific timing for reagent inputs, incubation at specific temperatures, and/or dialysis. Depending upon the particular IVD assay, system components may differ slightly. In each case however, a system consists of an autosampler, a pump for reagents and sample streams, a module where assay chemistry occurs, a detector (including flowcell), and an interface unit that facilitates communication with the software. The proposed modifications to the analyzer system components allow for 2 new unique system options; they are as follows: - 1. 350D Interface Unit: The predicate interface unit used for communications between detectors and software has been updated to accommodate the new software*. OR - 2. 307 Digital Photometer/Fluorometer: A new detector has been developed as an alternative to using the interface unit and predicate fluorometric detector. It is intended to be used with the new software*. AND *NeoPac: A new software package has been developed to replace outdated software. The 2 options listed above both depend on this software to complete the system. Each new or modified component is briefly described below: NeoPac Software: NeoPac is a newly developed software package designed to replace Astoria-Pacific's predicate software package. It is intended for use with new components and Microsoft® operating systems currently on the market. The software facilitates similar instrument controls as the predicate package, while adding minor but important functionality. 350D Interface Unit: The 350D facilitates electronic communication between NeoPac software and the detector(s), autosampler and pump. Each unit has 7 analog detector inputs on the front panel, a power cord connection, and cable connections for a PC, autosampler and pump. Its sole purpose is to provide a mechanism for commands and data to flow to and from the software and system components. The 350D is modified from the predicate device (350 Interface Unit) in order to communicate with new software. 307 Digital Photometer/Fluorometer: The 307 detector is a newly developed detection platform intended to provide an alternative option to the interface unit and one or more detectors in the SPOTCHECK analyzer system. Aside from providing a state-of-the-art option for detection, its spatial requirements are significantly less than the predicate device. It can be manufactured with up to 4 unique photometric or fluorometric detection channels and an additional analog input (offering the ability to connect to a standalone detector). In conjunction with NeoPac software, it facilitates the communication of data and commands between a PC, autosampler and pump. The 307 consists of a base module with up to 4 detection channels (not including a reference channel); each channel is either a fluorometer module or a photometric subassembly. The fluorometer module is a removable device that contains a flowcell, excitation LED, and emission bandpass filter. Each fluorometer module is manufactured according to the specifications of the assay it is intended to be used with. The photometric subassembly is not removable by the user. The only significant differences between the 307 and the predicate detectors (321 and 315) are the use of LEDs for excitation (fluorometry) and a bandpass filter instead of a monochromator (photometry).

SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1-phosphate UridyItransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.

SPOTCHECK Blood Spot Controls. Part No. 80-0900P4K, Blood Spot Controls, Deficient; 4 cards. Part No. 80-0901P4K, Blood Spot Controls, Normal; 4 cards. The controls are prepared with mixtures of human serum and human red blood cells. adjusted to approximately 55% hematocrit. Enzyme activity in the Deficient Control is decreased by heating. Enzyme activity in the Normal Control is supported by the addition of dithioerythritol (DTE). The mixtures are spotted on Whatman 903A filter paper and allowed to air dry at room temperature. The suppliers of serum and red blood cells certify that the materials have been tested using FDA-approved assays and shown to be negative for infectious disease agents. The SPOTCHECK Blood Spot Controls provide an ongoing indication of the assay performance. The Deficient Control responds below the assay cutoff, and the Normal Control responds above the assay cutoff within normal limits.

This method is for the semi-quantitative determination of biotinidase, EC 3.5.1.12, activity in dried whole blood spots using a spectrophotometer. Measurement of biotinidase activity is primarily for the diagnosis and treatment of biotinidase deficiency in newborns. This method is intended for in vitro diagnostic use in screening for decreased levels of biotinidase activity and not for monitoring purposes.

Biotinidase activity is determined by measuring the color that develops from p-Aminobenzoic Acid (PABA) after PABA is released from Biotinyl-p-Aminobenzoate (Biotin-PAB). Samples with biotinidase activity develop a purple color. Samples without biotinidase activity remain straw-colored. Patient samples of whole blood collected on standardized filter paper are eluted in a standard 96 well microplate. The plate is incubated with Biotin-PAB in a buffer at 37℃ for 240 minutes on a combination incubator/shaker. Following incubation, TCA is added to the sample mixture and the resulting precipitate is removed through filtration. The PABA in the filtrate is subsequently diazotized and coupled to a napthol derivative to form an azo dye by the successive addition of sodium nitrite, acidic ammonium sulfamate and finally, N-1-naphthylethylenediamine dihydrochloride (NED). The azo dye is measured colorimetrically at 550 nm on a commercial microplate absorbance reader with a reference measurement at 690 mm.

The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is intended for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes using the Astoria-Pacific SPOTCHECK Analyzer. Measurements of glucose-6-phosphate dehydrogenase activity are used primarily in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a G6PD deficiency. It is for in vitro diagnostic use primarily as an aid in screening for decreased levels of G6PD enzyme activity. This device is for use by trained, qualified laboratory personnel.

The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is a reagent kit used for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes. The method is based on the spectrophotometric method where enzyme activity is measured by observing NADP+ reduction to NADPH when glucose-6-phosphate is present as a substrate. Maleimide is added to inhibit the production of NADPH by 6-phosphogluconate dehydrogenase. The fluorescent NADPH produced is proportional to the G6PD enzyme activity. The kit contains Extraction Buffer, Tris Buffer, G6PD Substrate, and NADH Stock Std reagents.

This method is for the quantitative determination of the amino acid tyrosine in whole blood saturated filter paper disks using the APF™ 300 SPOTCHECK® Analyzer or the RFA 300 System. Measurements obtained by this device are used primarily to screen newborns for congenital tyrosinemia, a disease that can cause liver/kidney disorders.

The proposed device, Tyrosine 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 amino acid tyrosine (Tyr) in whole blood saturated filter paper disks. The amount of Tvr is determined by measuring the fluorescent compound produced in the reaction of tyrosine with 1-nitroso-2-naphthol, catalyzed by nitrous acid at 80°C. The excitation wavelength of the product is 450 nm and emission is measured at 550 nm. The method is specific for para-substituted phenolic compounds. Excess 1-nitroso-2-naphthol is removed from the reaction mixture by reduction with sodium m-bisulfite. 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.

This Astoria-Pacific SPOTCHECK® Undyttransferase 50-Hour Reagent Kit is for the qualifative determination of galactose-1-phosphate uridyttransferase, EC 2.7.12 (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 undyttransferase 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.

The proposed device, Unidyttransferase 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 uridyttransferase (UT) in whole blood saturated filter paper disks. The amount of unidyltransferase 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 it's emission is measured at 550 nm. The method is specific for uridy transferase. 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 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 dikition to prepare a standard curve.