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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS017
Date Received04/10/2006
Decision Date06/14/2006
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the monitor and transmitter of the previously approved guardian rt system. The real-time monitor has a larger lcd for ease of viewing for the user and to support graphical display of the data. Also, in the real-time monitor, rf communication is received from the transmitter at 916. 35 mhz, which is the identical frequency used in the paradigm model mmt-515/715 insulin pumps (cleared under k040676). In addition, the meter readings for calibration can be manually entered, identical to the guardian rt, or automatically, via telemetry, when using the paradigm link meter in the identical scheme as in the previously cleared insulin pump. The calibration algorithm and glucose values reported by the system are identical between the guardian rt system and the guardian real-time system. The device, as modified, will be marketed under the trade name guardian real-time continuous glucose monitoring system and is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (ages 18 and older) with diabetes mellitus, for the purpose of improving diabetes management. It alerts if a glucose level falls below or rises above, preset values. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose meter and not on guardian real-time cgm system values. The guardian real-time cgm system provides real-time glucose values that allow users to track patterns in glucose concentrations and to possibly identify episodes of low and high blood glucose. It also stores the data so that it can be analyzed to track patterns. Glucose data can be further downloaded to pc software for analysis of historical values.