Cleared Traditional

K103487 - FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

K103487 is an FDA 510(k) clearance for FORA PNC100 DIGITAL PREGANCY TEST, manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K103487 · Taidoc Technology Corporation · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2011
Decision
312d
Days
Class 2
Risk

K103487 is an FDA 510(k) clearance for the FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on October 4, 2011 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Taidoc Technology Corporation devices

FDA 510(k) Submission Details - K103487

510(k) Number K103487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2010
Decision Date October 04, 2011
Days to Decision 312 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
224d slower than avg
Panel avg: 88d · This submission: 312d
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 157
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K103487.
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907 · Polymed Therapeutics, Inc. · Mar 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
K123050 · Nantong Biotechnology Co., Ltd. · Feb 2013
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449 · Tianjin New Bay Bioresearch Co., Ltd. · Sep 2012
PREGNANCY ONE STEP RAPID TEST
K103574 · Lehnus & Associates Consulting · Jul 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
K110889 · Ind Diagnostics, Inc. · Jun 2011
CLEARBLUE EASY PREGNANCY TEST
K110433 · SPD Development Company Limited · May 2011