Cleared Special

K050872 - ACCU-CHEK INTEGRA SYSTEM

K050872 is an FDA 510(k) clearance for ACCU-CHEK INTEGRA SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code LFR cleared through the Special 510(k) pathway after a 26-day FDA review.

K050872 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
26d
Days
Class 2
Risk

K050872 is an FDA 510(k) clearance for the ACCU-CHEK INTEGRA SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 2, 2005 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K050872

510(k) Number K050872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2005
Decision Date May 02, 2005
Days to Decision 26 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Chemistry devices follow this clearance model.

Regulatory Peers - LFR Glucose Dehydrogenase, Glucose

All 56
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K050872.
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