Cleared Traditional

K063276 - CLINITEK ADVANTUS

K063276 is an FDA 510(k) clearance for CLINITEK ADVANTUS, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K063276 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
59d
Days
Class 2
Risk

K063276 is an FDA 510(k) clearance for the CLINITEK ADVANTUS, MODEL 1420. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Norowood, US). The FDA issued a Cleared decision on December 28, 2006 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K063276

510(k) Number K063276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2006
Decision Date December 28, 2006
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 37
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K063276.
FORESIGHT U120 URINE ANALYZER
K120124 · ACON Laboratories, Inc. · Mar 2012
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673 · Teco Diagnostics · Feb 2011
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · Siemens Healthcare Diagnostics · Oct 2009
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · Roche Diagnostics Corp. · Oct 2003
URS-IG (GLUCOSE TEST)
K020175 · Teco Diagnostics · Mar 2002
URISYS 2400 URINE TEST STRIP
K012397 · Roche Diagnostics Corp. · Sep 2001