Cleared Traditional

K003856 - EZ-HCG URINE(PREGNANCY TEST)

K003856 is an FDA 510(k) clearance for EZ-HCG URINE(PREGNANCY TEST), manufactured by Biomerica, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K003856 · Biomerica, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
70d
Days
Class 2
Risk

K003856 is an FDA 510(k) clearance for the EZ-HCG URINE(PREGNANCY TEST). Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on February 21, 2001 after a review of 70 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 Biomerica, Inc. devices

FDA 510(k) Submission Details - K003856

510(k) Number K003856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2000
Decision Date February 21, 2001
Days to Decision 70 days
Submission Type Traditional
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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 303
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K003856.
HCG STAT PAK ULTRA-FAST
K011550 · Chembio Diagnostic Systems, Inc. · Aug 2001
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc. · Jul 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · Sa Scientific, Inc. · Apr 2001
DBEST HCG 2 IU/ML TEST KIT
K001215 · Ameritek, Inc. · Jun 2000
ADVANTAGE HCG TEST (URINE/SERUM)
K994227 · Advantage Diagnostics Corp. · Feb 2000
CLEARVIEW EASY HCG PREGNANCY TEST
K993703 · Unipath , Ltd. · Dec 1999