Cleared Traditional

K925435 - QUICKVUE ONE-STEP HCG TEST

K925435 is an FDA 510(k) clearance for QUICKVUE ONE-STEP HCG TEST, manufactured by Quidel Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K925435 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
36d
Days
Class 2
Risk

K925435 is an FDA 510(k) clearance for the QUICKVUE ONE-STEP HCG TEST. 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 December 3, 1992 after a review of 36 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

FDA 510(k) Submission Details - K925435

510(k) Number K925435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1992
Decision Date December 03, 1992
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 251
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K925435.
ACCESS TOTAL BHCG ASSAY
K926198 · Bio-Rad Laboratories, Inc. · Feb 1993
SAS ONE STEP PREGNANCY
K926204 · Sa Scientific, Inc. · Feb 1993
PRO-STEP HCG
K925125 · Disease Detection International, Inc. · Jan 1993
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259 · Medix Biotech, Inc. · Nov 1992
VISUAL HCG PREGNANCY TEST
K923376 · Tech-Co, Inc. · Oct 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992