Cleared Traditional

K901981 - ABBOTT MODIFIED FACT PLUS PREGNANCY TEST

K901981 is an FDA 510(k) clearance for ABBOTT MODIFIED FACT PLUS PREGNANCY TEST, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K901981 · Abbott Laboratories · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1990
Decision
92d
Days
Class 2
Risk

K901981 is an FDA 510(k) clearance for the ABBOTT MODIFIED FACT PLUS PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 2, 1990 after a review of 92 days - within the typical 510(k) review window.

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: 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.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K901981

510(k) Number K901981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date August 02, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 125
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K901981.
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
K912316 · Syntron Bioresearch, Inc. · Jul 1991
CLEARBLUE EASY
K911566 · Unipath , Ltd. · May 1991
CLEARBLUE EASY
K905742 · Unipath , Ltd. · Feb 1991
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
K896482 · Pacific Biotech, Inc. · Mar 1990
CLEARBLUE EASY
K882416 · Unipath , Ltd. · Jul 1988
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
K874823 · Tambrands, Inc. · Apr 1988