Cleared Traditional

K020801 - QUICKVUE ONE-STEP HCG-COMBO

K020801 is the FDA 510(k) clearance for QUICKVUE ONE-STEP HCG-COMBO by Quidel Corp.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K020801 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
66d
Days
Class 2
Risk

K020801 is an FDA 510(k) clearance for the QUICKVUE ONE-STEP HCG-COMBO. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on May 17, 2002 after a review of 66 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 Quidel Corp. devices

Submission Details

510(k) Number K020801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date May 17, 2002
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
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 118
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K020801.
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
STATUS HCG SERUM/URINE
K020439 · Princeton BioMeditech Corp. · May 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · Quidel Corp. · May 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc. · Mar 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · Diagnostic Systems Laboratories, Inc. · Mar 2002
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc. · Jul 2001