Cleared Traditional

K091287 - VS-SENSE TEST

K091287 is an FDA 510(k) clearance for VS-SENSE TEST, manufactured by Common Sense , Ltd.. The device is a Class 1 Chemistry device with product code CEN cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K091287 · Common Sense , Ltd. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
122d
Days
Class 1
Risk

K091287 is an FDA 510(k) clearance for the VS-SENSE TEST. Classified as Dye-indicator, Ph (urinary, Non-quantitative) (product code CEN), Class I - General Controls.

Submitted by Common Sense , Ltd. (Washington, US). The FDA issued a Cleared decision on August 31, 2009 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1550 - 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.

FDA 510(k) Submission Details - K091287

510(k) Number K091287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2009
Decision Date August 31, 2009
Days to Decision 122 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
33d slower than avg
Panel avg: 89d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

CEN Device Classification - Class 1, General Controls

Product Code CEN Dye-indicator, Ph (urinary, Non-quantitative)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Clinical Evidence

ClinicalTrials.gov
NCT00803127 Completed Observational

VS-Sense Result Reading Clarity

120
Patients (est.)
1
Site
Condition studied Vaginitis
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Sponsor Carmel Medical Center
Started 2009-01-01 → Primary completion 2009-04-01 → Completed 2009-05-01
Primary outcome
The clinician reports of the VS-SENSE test results, the pH measurement by Nitrazine Paper test records, and the results reading clarity grade from the clinician.
Study completed - no results published. This trial concluded in 2009 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - CEN Dye-indicator, Ph (urinary, Non-quantitative)

All 10
Devices cleared under the same product code (CEN) and FDA review panel - the closest regulatory comparables to K091287.
AMNISCREEN HOME DETECTION LINER KIT
K071100 · Common Sense , Ltd. · Oct 2007
AIMSTICK URINE REAGENT STRIPS
K051727 · Germaine Laboratories, Inc. · Oct 2005
QUICKVUE ADVANCE PH AND AMINES GLL TEST
K040008 · Quidel Corp. · Apr 2004
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
K030650 · Uridynamics, Inc. · Apr 2003
FEMEXAM TESTCARD
K962718 · Litmus Concepts, Inc. · Feb 1997
KYOTEST 5V
K840827 · Kyoto Diagnostics, Inc. · May 1984
K091287 · VS-SENSE TEST
Download PDF FDA Summary Common Sense , Ltd.