Cleared Traditional

K130456 - WUNDER PREGNANCY TEST

K130456 is an FDA 510(k) clearance for WUNDER PREGNANCY TEST, manufactured by James Nguyen. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 410-day FDA review.

K130456 · James Nguyen · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
410d
Days
Class 2
Risk

K130456 is an FDA 510(k) clearance for the WUNDER PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by James Nguyen (San Jose, US). The FDA issued a Cleared decision on April 8, 2014 after a review of 410 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all James Nguyen devices

FDA 510(k) Submission Details - K130456

510(k) Number K130456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2013
Decision Date April 08, 2014
Days to Decision 410 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
322d slower than avg
Panel avg: 88d · This submission: 410d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 293
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K130456.
Atellica IM Total hCG (ThCG)
K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
K172257 · True Diagnostics, Inc. · Dec 2017
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
K152768 · Assure Tech. Co., Ltd. · Feb 2016
FASTEP S10 HCG SERUM/URINE COMBO TEST
K132834 · Polymed Therapeutics, Inc. · Jan 2014
SOFIA(R) HCG FIA
K131166 · Quidel Corp. · Aug 2013
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
K123844 · Chemtron Biotech, Inc. · May 2013