Cleared Traditional

K983047 - ACCU-CHEK HQ SYSTEM

K983047 is an FDA 510(k) clearance for ACCU-CHEK HQ SYSTEM, 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 157-day FDA review.

K983047 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
157d
Days
Class 2
Risk

K983047 is an FDA 510(k) clearance for the ACCU-CHEK HQ SYSTEM. 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 5, 1999 after a review of 157 days - an extended review cycle.

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 - K983047

510(k) Number K983047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1998
Decision Date February 05, 1999
Days to Decision 157 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
69d slower than avg
Panel avg: 88d · This submission: 157d
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 K983047.
ACCU-CHEK COMPLETE METER
K000364 · Roche Diagnostics Corp. · Feb 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684 · Abbott Diabetes Care, Inc. · Jan 2000
ACCU-CHEK SIMPLICITY SYSTEM
K993829 · Roche Diagnostics Corp. · Dec 1999
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
K982089 · Boehringer Mannheim Corp. · Sep 1998
ACCU-CHEK COMFORT CURVE TEST STRIP
K982002 · Boehringer Mannheim Corp. · Sep 1998
ACCU-CHECK VOICEMATE
K982079 · Boehringer Mannheim Corp. · Aug 1998