Cleared Traditional

K902681 - EZ-SCREEN:HCG

K902681 is the FDA 510(k) clearance for EZ-SCREEN:HCG by Environmental Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K902681 · Environmental Diagnostics, Inc. · Chemistry device
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Aug 1990
Decision
51d
Days
Class 2
Risk

K902681 is an FDA 510(k) clearance for the EZ-SCREEN:HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Environmental Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 51 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 Environmental Diagnostics, Inc. devices

Submission Details

510(k) Number K902681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date August 09, 1990
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 K902681.
CLEARVIEW HCG SERUM/URINE
K905741 · Unipath , Ltd. · May 1991
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · Ciba Corning Diagnostics Corp. · Oct 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · Abbott Laboratories · Sep 1990
AFFINITY HCG TEST SYSTEM
K902720 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136 · Eastman Kodak Company · Jun 1990
OPUS (TM) HCG
K901935 · Pb Diagnostic Systems, Inc. · Jun 1990