Cleared Traditional

K974052 - QUICKVUE SEMI-Q HCG-COMBO

K974052 is the FDA 510(k) clearance for QUICKVUE SEMI-Q HCG-COMBO by Quidel Corp.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K974052 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
53d
Days
Class 2
Risk

K974052 is an FDA 510(k) clearance for the QUICKVUE SEMI-Q 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 December 19, 1997 after a review of 53 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 K974052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1997
Decision Date December 19, 1997
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 K974052.
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
K981444 · Princeton BioMeditech Corp. · Jul 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443 · Princeton BioMeditech Corp. · Jun 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · Beckman Instruments, Inc. · Mar 1998
QUICKVUE ONE-STEP HCG-COMBO
K973841 · Quidel Corp. · Dec 1997
CARDS Q.S. HCG SERUM/URINE
K973858 · Quidel Corp. · Nov 1997
QUICKVUE ONE-STEP HCG-URINE
K972742 · Quidel Corp. · Aug 1997