Cleared Traditional

K981722 - QUIDEL HOME PREGNANCY TEST

K981722 is the FDA 510(k) clearance for QUIDEL HOME PREGNANCY TEST by Quidel Corp.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K981722 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
19d
Days
Class 2
Risk

K981722 is an FDA 510(k) clearance for the QUIDEL HOME PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on June 3, 1998 after a review of 19 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 Quidel Corp. devices

Submission Details

510(k) Number K981722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1998
Decision Date June 03, 1998
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
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 98
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K981722.
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · Unipath , Ltd. · Apr 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373 · Abbott Laboratories · Feb 1999
ACON MIDSTREAM PREGNANCY TEST
K983090 · ACON Laboratories, Inc. · Nov 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · Quidel Corp. · Jan 1998
SIGNAL PREGNANCY TEST KIT
K974021 · Sa Scientific, Inc. · Dec 1997
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154 · Sa Scientific, Inc. · Dec 1997