Cleared Traditional

K033041 - ACON QUIK-CHECK II HOME PREGNANCY TEST ...

K033041 is the FDA 510(k) clearance for ACON QUIK-CHECK II HOME PREGNANCY TEST ... by ACON Laboratories, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K033041 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
53d
Days
Class 2
Risk

K033041 is an FDA 510(k) clearance for the ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 2003 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 ACON Laboratories, Inc. devices

Submission Details

510(k) Number K033041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 21, 2003
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 111
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K033041.
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · Unipath , Ltd. · Mar 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · Unipath , Ltd. · Mar 2004
E.P.T. PREGNANCY TEST
K033658 · Unipath , Ltd. · Jan 2004
EPT CERTAINTY PREGNANCY TEST
K032939 · Unipath , Ltd. · Oct 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661 · ACON Laboratories, Inc. · Oct 2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510 · ACON Laboratories, Inc. · Sep 2003