Cleared Special

UNIMARK HCG COMBO PREGNANCY TEST (K013194) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013194 · Biotech Atlantic, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
15d
Days
Class 2
Risk

K013194 is an FDA 510(k) clearance for the UNIMARK HCG COMBO PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Biotech Atlantic, Inc. (Eatontown, US). The FDA issued a Cleared decision on October 10, 2001 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biotech Atlantic, Inc. devices

Submission Details

510(k) Number K013194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date October 10, 2001
Days to Decision 15 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 374
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K013194.
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
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc. · Mar 2002