Cleared Traditional

K042641 - CHEMVIEW-10

K042641 is an FDA 510(k) clearance for CHEMVIEW-10, manufactured by Cenogenics Corp.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K042641 · Cenogenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
102d
Days
Class 2
Risk

K042641 is an FDA 510(k) clearance for the CHEMVIEW-10. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Cenogenics Corp. (Morganville, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 102 days - within the typical 510(k) review window.

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. 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 Cenogenics Corp. devices

FDA 510(k) Submission Details - K042641

510(k) Number K042641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date January 07, 2005
Days to Decision 102 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
14d slower than avg
Panel avg: 88d · This submission: 102d
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 55
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K042641.
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
K052525 · DFI Co., Ltd. · Mar 2006
URYXXON 200 URINE ANALYZER
K051034 · Macherey-Nagel GmbH & Co. KG · Nov 2005
URISCAN OPTIMA II URINE ANALYZER
K050801 · Yd Diagnostics · Apr 2005
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · Roche Diagnostics Corp. · Oct 2003
POCKETCHEM UA AUTION STICKS 10TA
K022386 · Arkray, Inc. · Sep 2002
URS-IG (GLUCOSE TEST)
K020175 · Teco Diagnostics · Mar 2002