Cleared Traditional

K040008 - QUICKVUE ADVANCE PH AND AMINES GLL TEST

K040008 is an FDA 510(k) clearance for QUICKVUE ADVANCE PH AND AMINES GLL TEST, manufactured by Quidel Corp.. The device is a Class 1 Chemistry device with product code CEN cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K040008 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
118d
Days
Class 1
Risk

K040008 is an FDA 510(k) clearance for the QUICKVUE ADVANCE PH AND AMINES GLL TEST. Classified as Dye-indicator, Ph (urinary, Non-quantitative) (product code CEN), Class I - General Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on April 29, 2004 after a review of 118 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 - K040008

510(k) Number K040008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2004
Decision Date April 29, 2004
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
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.

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

All 8
Devices cleared under the same product code (CEN) and FDA review panel - the closest regulatory comparables to K040008.
VS-SENSE TEST
K091287 · Common Sense , Ltd. · Aug 2009
AMNISCREEN HOME DETECTION LINER KIT
K071100 · Common Sense , Ltd. · Oct 2007
AIMSTICK URINE REAGENT STRIPS
K051727 · Germaine Laboratories, Inc. · Oct 2005
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
K030650 · Uridynamics, Inc. · Apr 2003
FEMEXAM TESTCARD
K962718 · Litmus Concepts, Inc. · Feb 1997
URINE SCREENING KIT
K830824 · Syn-Kit, Inc. · Jun 1983
K040008 · QUICKVUE ADVANCE PH AND AMINES GLL TEST
Download PDF FDA Summary Quidel Corp.