Cleared Traditional

K941090 - UNISTEP HCG PREGNANCY TEST STRIP

K941090 is an FDA 510(k) clearance for UNISTEP HCG PREGNANCY TEST STRIP, manufactured by Biotech Atlantic, Inc.. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K941090 · Biotech Atlantic, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
86d
Days
Class 2
Risk

K941090 is an FDA 510(k) clearance for the UNISTEP HCG PREGNANCY TEST STRIP. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Biotech Atlantic, Inc. (Eatontown, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biotech Atlantic, Inc. devices

FDA 510(k) Submission Details - K941090

510(k) Number K941090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date June 02, 1994
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

Product Code DHA System, Test, Human Chorionic Gonadotropin
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 - DHA System, Test, Human Chorionic Gonadotropin

All 55
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K941090.
AMERLITE HCG-60 ASSAY
K952283 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
AURAFLEX HCG
K945331 · Organon Teknika Corp. · Mar 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
K950307 · Princeton BioMeditech Corp. · Mar 1995
SAS(TM) SERUM/URINE HCG
K932409 · Sa Scientific, Inc. · Jun 1993
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
K922073 · Baxter Diagnostics, Inc. · Oct 1992
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · Baxter Healthcare Corp · Aug 1991