Cleared Traditional

K050760 - ACCU-CHEK POCKET COMPASS DIABETES MANAG...

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

K050760 · Roche Diagnostics Corp. · General Hospital
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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.

View all Roche Diagnostics Corp. devices

Submission Details

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.

Device Classification

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 12
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K050760.
Omnipod DASH Insulin Management System
K180045 · Insulet Corporation · Jun 2018
ACCU-CHECK COMBO SYSTEM
K111353 · Roche Diagnostics · Jul 2012
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · Roche Diagnostics · Oct 2008
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · Cardiac Pacemakers, Inc. · Feb 1990