CLIA - Clinical Laboratory Improvement Amendments

Test System Name	CYGNUS, INC. GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Document Number	P990026
Analyte Name	Glucose, Fluid (Approved By Fda For Prescription Home Use)
Analyte Specialty	General Chemistry
Complexity	WAIVED
Effective Date	03/28/2001

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

Trade Name

GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Classification Name

instrument, glucose, noninvasive technology

Generic Name

glucose test system

Applicant

ANIMAS CORP.

PMA Number

P990026

Date Received

06/01/1999

Decision Date

03/22/2001

Product Code

NCT	[ Registered Establishments with NCT ]

Docket Number

01M-0371

Notice Date

08/29/2001

Advisory Committee

Clinical Chemistry

Expedited Review Granted?

Yes

Information About:

Labeling, Approval Order, Summary of Safety and Effectiveness

Approval Order Statement
Approval for the glucowatch(r) automatic glucose biographer. The device is indicated for: the glucowatch(r) automatic glucose biographer is a glucose monitoring device indicated for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) with diabetes. The device is intended for use by patients at home and in health care facilities. The glucowatch biographer is indicated for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. The biographer is indicated for use in the detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of biographer results whould be based on the trends and patterns seen with several sequential readings over time.

Supplements:

S001 S002 S004 S005 S006 S007
S008 S009 S010 S011 S012 S013
S014 S015 S016 S017 S018 S019
S020 S021 S022