Cleared Traditional

K050760 - ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE

K050760 is an FDA 510(k) clearance for ACCU-CHEK POCKET COMPASS DIABETES MANAG..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K050760 · Roche Diagnostics Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
173d
Days
Class 2
Risk

K050760 is an FDA 510(k) clearance for the ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 13, 2005 after a review of 173 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K050760

510(k) Number K050760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2005
Decision Date September 13, 2005
Days to Decision 173 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 129d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZG Device Classification - Class 2, Special Controls

Product Code LZG Pump, Infusion, Insulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LZG Pump, Infusion, Insulin

All 83
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K050760.
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001
K060876 · Disetronic Medical Systems AG · Jun 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177 · Medtronic Minimed · Jan 2006
INSULIN PUMP
K051041 · Abbott Diabetes Care, Inc. · Dec 2005
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
K050971 · Biovalve Technologies, Inc. · Aug 2005
AMIGO INSULIN PUMP
K050312 · Nipro Diabetes Systems, Inc. · May 2005
ACCU-CHEK SPIRIT
K042887 · Disetronic Medical Systems AG · Mar 2005
K050760 · ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Download PDF FDA Summary Roche Diagnostics Cor…