Cleared Traditional

K110889 - IND ONE STEP HCG URINE PREGNANCY TEST (...

K110889 is the FDA 510(k) clearance for IND ONE STEP HCG URINE PREGNANCY TEST (... by Ind Diagnostics, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K110889 · Ind Diagnostics, Inc. · Chemistry device
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Jun 2011
Decision
82d
Days
Class 2
Risk

K110889 is an FDA 510(k) clearance for the IND ONE STEP HCG URINE PREGNANCY TEST (STRIP). Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Ind Diagnostics, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on June 20, 2011 after a review of 82 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 Ind Diagnostics, Inc. devices

Submission Details

510(k) Number K110889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2011
Decision Date June 20, 2011
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K110889.
ACRO HCG Pregnancy Rapid Test
K172512 · Acro Biotech, Inc. · Feb 2018
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
K150022 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2015
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd. · Jul 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · Unipath , Ltd. · May 2006
ACON +/- MIDSTREAM PREGNANCY TEST
K050546 · ACON Laboratories, Inc. · May 2005