Cleared Traditional

K112315 - HOME PREGNANCY TEST

K112315 is an FDA 510(k) clearance for HOME PREGNANCY TEST, manufactured by Newscen Coast Bio-Pharmaceutical Co., Ltd.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K112315 · Newscen Coast Bio-Pharmaceutical Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
256d
Days
Class 2
Risk

K112315 is an FDA 510(k) clearance for the HOME PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Newscen Coast Bio-Pharmaceutical Co., Ltd. (Simi Valley, US). The FDA issued a Cleared decision on April 23, 2012 after a review of 256 days - an extended review 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: 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 Newscen Coast Bio-Pharmaceutical Co., Ltd. devices

FDA 510(k) Submission Details - K112315

510(k) Number K112315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2011
Decision Date April 23, 2012
Days to Decision 256 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 88d · This submission: 256d
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 240
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K112315.
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