Cleared Special

K013194 - UNIMARK HCG COMBO PREGNANCY TEST

K013194 is an FDA 510(k) clearance for UNIMARK HCG COMBO PREGNANCY TEST, manufactured by Biotech Atlantic, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Special 510(k) pathway after a 15-day FDA review.

K013194 · Biotech Atlantic, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K013194

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 358
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K013194.
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · Diagnostic Systems Laboratories, Inc. · Mar 2002
VICTORCH HCG TEST STRIP
K013702 · Victorch Meditek, Inc. · Dec 2001
POLY STAT HCG TEST
K012559 · Bion Diagnostic Sciences · Oct 2001
WH ACCU TEST PREGNANCY TEST
K012284 · W.H.P.M., Inc. · Aug 2001
HCG STAT PAK ULTRA-FAST
K011550 · Chembio Diagnostic Systems, Inc. · Aug 2001
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc. · Jul 2001
K013194 · UNIMARK HCG COMBO PREGNANCY TEST
Download PDF FDA Summary Biotech Atlantic, Inc.