Cleared Traditional

K021386 - POLY STAT HCG DIPSTICK TEST

K021386 is an FDA 510(k) clearance for POLY STAT HCG DIPSTICK TEST, manufactured by Alidex, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K021386 · Alidex, Inc. · Chemistry device
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Aug 2002
Decision
95d
Days
Class 2
Risk

K021386 is an FDA 510(k) clearance for the POLY STAT HCG DIPSTICK TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Alidex, Inc. (Redmond, US). The FDA issued a Cleared decision on August 5, 2002 after a review of 95 days - within the typical 510(k) review window.

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.

View all Alidex, Inc. devices

FDA 510(k) Submission Details - K021386

510(k) Number K021386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2002
Decision Date August 05, 2002
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
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 283
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K021386.
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544 · Genzyme Corp. · Jan 2003
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
QUPID PLUS E.R.
K020378 · Stanbio Laboratory · Jun 2002
STATUS HCG SERUM/URINE
K020439 · Princeton BioMeditech Corp. · May 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · Quidel Corp. · May 2002