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The pHoenix ISE Standard for Roche AVL Instruments are intended for use as ISE Reagents for the determination of Na', K', Cli, Ca and Li* in human serum samples on the Roche AVL Systems. The standards are used for the calibration of the Roche AVL Instruments for the quantitative determination of Nat, K* Cl*, Ca* and Li+ in serum samples.

pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for Standard A. B. and C for the Roche AVL Systems for the quantitative determination of Na+, K+, Cl-, Ca+ and Li+ in human serum. These Standards are used for the calibration of the Roche AVL Systems. The products encompassed by this 510 (k) submission are Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Standards are intended to serve as direct replacements to like named products manufactured by Roche Diagnostics. pHoenix Diagnostics uses a similar composition and design as that used by Roche Diagnostics in its products.

The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na , K , C1 and C02 in human serum samples on the Beckman CX Systems. The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and C02. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02. The C02 Acid Reagent is to release C02 from serum samples. The C02 Alkaline Buffer is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems. The Calibrators are used for the calibration of the CX ISE Modules for the quantitative determination of Na+, K+ Cl+and C02 in serum samples.

pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for the following: (1) Electrolyte Buffer, (2) Electrolyte Reference Reagent and (3) C02 Acid Reagent, (4) C02 Alkaline Buffer, (5) Wash Concentrate and (6) ISE Calibrator Level 1,2 and 3. These ISE Reagents are intended for use on the ISE Module of the Beckman CX Systems for the quantitative determination of Na+, K+, C1- and C02 in human serum. The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in human serum samples. The Electrolyte Buffer is combined with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, C1- and C02. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02. The C02 Acid Reagent is to release C02 from serum samples, The C02 Alkaline Reagent is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems. The Calibrators are used for the calibration of the CX ISE Modules.

The pHoenix ISE Reagents for Olympus® AU Chemistry Systems are intended for use as ISE Reagents for the determination of Nat, K+, and Cli for the Olympus® AU Clinical Chemistry Systems. The ISE Buffer is intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cl in serum by ISE. The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na * and Cl in serum samples on the Olympus® AU Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Na , K+ and Cli Electrodes on the Olympus® AU ISE systems.

The products encompassed by this 510 (k) submission are Class I (75JJG) and Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Reagents are intended to serve as direct replacements to like named products manufactured by Olympus® Diagnostics. Listed below are pHoenix products and their Olympus® Diagnostics equivalents. | pHoenix<br>Cat.# | Olympus<br>Cat. # | Description | Models | Class | |------------------|-------------------|---------------------------------|--------|-------| | TBD | AUH1011 | ISE Buffer | AU | 1 | | TBD | AUH1017 | ISE Internal Reference Solution | AU | 1 | | TBD | AUH1014 | ISE Low Standard | AU | 2 | | TBD | AUH1015 | ISE High Standard | AU | 2 | pHoenix uses a similar composition, description and packaging design as that used by Olympus® Diagnostics in its products.

The products encompassed by this request are intended for invitro diagnostic use and are intended for use in calibrating Nat, K+, Cli electrodes in Roche Cobas ISE module. Roche is the original equipment manufacturer for the analyzer and predicate reagents. phoenix electrolyte calibration set is intended for use in playe of like named products manufactured by Roche Diagnostics.

The products encompassed by this 510 (k) submission are Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. The Calibration Set consists of 2 levels and is intended for use in calibrating Na*, K* and CI on the Roche® Cobas™ ISE Module. Roche Diagnostics is the original equipment manufacturer (OEM) of the system. The pHoenix Calibrator Reagents are intended to serve as direct replacements to like named products manufactured by Roche Diagnostics. pHoenix Product 17-200 and 17-201 are equivalent to Roche Product 44224. pHoenix uses a similar composition, description and packaging design as that used by Roche Diagnostics in its products.

The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K*, and Cli for the Roche Hitachi 700/900 Series Clinical Chemistry Systems. The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.

pHoenix ISE reagent for Roche Hitachi Clinical Chemistry 700 and 900 Series Systems: pHoenix Diagnostics, Inc. is submitting a 510 (K) notification for the following: (1) pHoenix ISE Diluent, (2) ISE Internal Reference Solution and (3) ISB Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Roche Hitachi Clinical Chemistry Systems. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Nat, K* and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na", K+ and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Nat, K+ and Cl Electrodes on the ISE system.

The pHoenix Electrolyte Calibrator Set for the Medica EasyLyte Calcium Analyzer is intended for use as The procedes to calibrate Nat, K+, Ca* and pH for the Medica EasyLyte Calcium Analyzer.

Phoenix Electrolyte Calibration Set for Medica Easylyte Analyzer consists of two standards A and B for use in calibrating Nat, Kt, Cat+ and pH electrodes. The Medica Easylyte Calcium Analyzer measures Na , K , Ca + , and pH using ion selective electrode technology. pHoenix calibration set is intended to serve as direct replacement to similar calibrator manufactured by Medica Corporation. pHoenix uses similar composition, description and packaging design as that used by Medica Corporation in its calibration set.

The pHoenix Electrolyte Calibrator Set is intended for use as calibrators to calibrate Na ", K ", CI and TCO2 for the Dade/Behring Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed.

The products encompassed by this 510 (k) submission are Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. The Calibration Set consists of an A, B and Clevel and is intended for use in calibrating Nat, K., C." and TCO2 analytes on the Dade/Behring Dimension Chemistry Systems. Dade/Behring Chemistry Systems, Inc. is the original equipment manufacturer (OEM) of the system,