Cleared Traditional

K954833 - ACCU-CHEK ADVANTAGE TEST STRIPS

K954833 is an FDA 510(k) clearance for ACCU-CHEK ADVANTAGE TEST STRIPS, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K954833 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
118d
Days
Class 2
Risk

K954833 is an FDA 510(k) clearance for the ACCU-CHEK ADVANTAGE TEST STRIPS. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 15, 1996 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K954833

510(k) Number K954833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1995
Decision Date February 15, 1996
Days to Decision 118 days
Submission Type Traditional
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
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 47
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K954833.
ACCU-CHEK COMFORT CURVE TEST STRIPS
K980731 · Boehringer Mannheim Corp. · May 1998
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
K973662 · Boehringer Mannheim Corp. · Dec 1997
GLUCOTREND BASIC SYSTEM
K972876 · Boehringer Mannheim Corp. · Oct 1997
GLUCOSE TEST ITEM NUMBER 97375/94
K951750 · Emd Chemicals, Inc. · Sep 1995
ADVANTAGE TEST STRIPS
K951887 · Boehringer Mannheim Corp. · Aug 1995
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · Em Diagnostic Systems, Inc. · Dec 1987