Cleared Special

K050546 - ACON +/- MIDSTREAM PREGNANCY TEST

K050546 is an FDA 510(k) clearance for ACON +/- MIDSTREAM PREGNANCY TEST, manufactured by ACON Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Special 510(k) pathway after a 79-day FDA review.

K050546 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
79d
Days
Class 2
Risk

K050546 is an FDA 510(k) clearance for the ACON +/- MIDSTREAM PREGNANCY TEST. 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 May 20, 2005 after a review of 79 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K050546

510(k) Number K050546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date May 20, 2005
Days to Decision 79 days
Submission Type Special
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
9d faster than avg
Panel avg: 88d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

LCX Device Classification - Class 2, Special Controls

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 165
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K050546.
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
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CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · Unipath , Ltd. · May 2006
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
K050305 · Bioscreen Medical, Inc. · May 2005
E.P.T. CERTAINTY PREGNANCY TEST
K050930 · Unipath , Ltd. · May 2005
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
K043231 · Mizuho USA, Inc. · Apr 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2005