Cleared Traditional

K023885 - COMBI-SCREEN, MODELS 10SL AND 11SL

K023885 is an FDA 510(k) clearance for COMBI-SCREEN, manufactured by Analyticon Biotechnologies AG. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K023885 · Analyticon Biotechnologies AG · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
334d
Days
Class 2
Risk

K023885 is an FDA 510(k) clearance for the COMBI-SCREEN, MODELS 10SL AND 11SL. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Analyticon Biotechnologies AG (Deer Field, US). The FDA issued a Cleared decision on October 21, 2003 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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. Elevated predicate reliance profile. 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 Analyticon Biotechnologies AG devices

FDA 510(k) Submission Details - K023885

510(k) Number K023885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2002
Decision Date October 21, 2003
Days to Decision 334 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 88d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIL Device Classification - Class 2, Special Controls

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 45
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