Cleared Traditional

K043529 - ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE

K043529 is an FDA 510(k) clearance for ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE, manufactured by Roche Diagnostics Corp.. The device is a Class 2 General Hospital device with product code NDC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K043529 · Roche Diagnostics Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
108d
Days
Class 2
Risk

K043529 is an FDA 510(k) clearance for the ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 8, 2005 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1890 - 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

FDA 510(k) Submission Details - K043529

510(k) Number K043529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2004
Decision Date April 08, 2005
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDC Device Classification - Class 2, Special Controls

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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.