Cleared Special

K993141 - AT HOME QUICKCUP PREGNANCY TEST

K993141 is the FDA 510(k) clearance for AT HOME QUICKCUP PREGNANCY TEST by Phamatech. It is a Class 2 Chemistry device (product code LCX) cleared through the Special 510(k) pathway after a 48-day FDA review.

K993141 · Phamatech · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
48d
Days
Class 2
Risk

K993141 is an FDA 510(k) clearance for the AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on November 8, 1999 after a review of 48 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 Phamatech devices

Submission Details

510(k) Number K993141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1999
Decision Date November 08, 1999
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

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 K993141.
ACON ONE STEP HOME PREGNANCY TEST STRIP
K993483 · ACON Laboratories, Inc. · Jan 2000
FIRST RESPONSE 1-STEP PREGNANCY
K992232 · Armkel, LLC · Dec 1999
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333 · Unipath , Ltd. · Dec 1999
SAS HCG-CHECK
K991193 · Sa Scientific, Inc. · May 1999
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · Unipath , Ltd. · Apr 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · Abbott Laboratories · Feb 1999