Cleared Traditional

K023823 - EASYCUP

K023823 is an FDA 510(k) clearance for EASYCUP, manufactured by Zer Hitech. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K023823 · Zer Hitech · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
188d
Days
Class 2
Risk

K023823 is an FDA 510(k) clearance for the EASYCUP. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Zer Hitech (Alpharetta, US). The FDA issued a Cleared decision on May 22, 2003 after a review of 188 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K023823

510(k) Number K023823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date May 22, 2003
Days to Decision 188 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
99d slower than avg
Panel avg: 89d · This submission: 188d
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 360
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K023823.
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987 · Unotech Diagnostics, Inc. · Nov 2003
MAINLINE MAXIE HCG URINE PREGNANCY TEST
K031445 · Mainline Technology, Inc. · Jul 2003
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
K031048 · Access Bio Incorporate · Jun 2003
POLY STAT SERUM/URINE HCG TEST
K030430 · Alidex, Inc. · Apr 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · Bayer Corp. · Feb 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544 · Genzyme Corp. · Jan 2003
K023823 · EASYCUP
Download PDF FDA Summary Zer Hitech