Cleared Traditional

K152768 - Assure Tech hCG Pregnancy Serum/Urine C...

K152768 is the FDA 510(k) clearance for Assure Tech hCG Pregnancy Serum/Urine C... by Assure Tech. Co., Ltd.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K152768 · Assure Tech. Co., Ltd. · Chemistry device
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Feb 2016
Decision
153d
Days
Class 2
Risk

K152768 is an FDA 510(k) clearance for the Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pr.... Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Assure Tech. Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 24, 2016 after a review of 153 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 Assure Tech. Co., Ltd. devices

Submission Details

510(k) Number K152768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2015
Decision Date February 24, 2016
Days to Decision 153 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
65d slower than avg
Panel avg: 88d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K152768.
Innovita HCG Pregnancy Rapid Combo Test
K241919 · Innovita (Tangshan) Biological Technology Co., Ltd. · Aug 2024
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · Hangzhou AllTest Biotech Co., Ltd. · Jan 2022
Atellica IM Total hCG (ThCG)
K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
SOFIA(R) HCG FIA
K131166 · Quidel Corp. · Aug 2013
RAPIDVUE HCG TEST
K102175 · Quidel Corporation · Aug 2010
LIFESIGN DXPRESS, MODEL LSR2000
K050955 · Princeton BioMeditech Corp. · Jan 2006