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510(k) Data Aggregation
K Number
K030650Device Name
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
Manufacturer
URIDYNAMICS, INC.
Date Cleared
2003-04-14
(45 days)
Product Code
CEN, JJW, JRE
Regulation Number
862.1550Why did this record match?
Applicant Name (Manufacturer) :
URIDYNAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UriDynamics StoneGuard™ II Test Strips are intended for semiquantitative measurement of pH and specific gravity in fresh urine. They can be used to monitor conditions that may cause the formation of kidney stones, namely trends in urinary pH and hydration status.
Confirm Low™ and Confirm High™ Control Solutions are intended for in vitro (external) use only, for use as control materials for StoneGuard™ II Test Strips only.
Device Description
UriDynamics StoneGuard™ II Test Strips consist of plastic carriers with two reagent pads attached. The pads respond to pH and specific gravity. StoneGuard™ II Test Strips are stored in an opaque vial with desiccant and are ready to use. Results may be read between 30 and 60 seconds after wetting with a freshly-voided urine sample. Results are obtained by comparing the color developed on the pads with a printed color chart. The results are semi-quantitative. Control solutions, Confirm Low™ and Confirm High™, intended for use with StoneGuard™ II Test Strips, are also included in this submission. Confirm Low™ and Confirm High™ contain buffers and salts that give a known response with StoneGuard™ II Test Strips. Confirm Low™ and Confirm High™ Control Solutions are ready to use in dispensers, and contain no biological ingredients.
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