Cleared Traditional

K894790 - QUIDEL HCG TEST

K894790 is the FDA 510(k) clearance for QUIDEL HCG TEST by Quidel Corp.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K894790 · Quidel Corp. · Chemistry device
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Oct 1989
Decision
89d
Days
Class 2
Risk

K894790 is an FDA 510(k) clearance for the QUIDEL 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 October 25, 1989 after a review of 89 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 K894790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1989
Decision Date October 25, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 88d · This submission: 89d
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 K894790.
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
ENZYMUN TEST R HCG
K896901 · Boehringer Mannheim Corp. · Feb 1990
MILENIA(TM) HCG (MKCG1,5)
K895809 · Diagnostic Products Corp. · Dec 1989
COAT-A-COUNT (TM) HCG IRMA
K894941 · Diagnostic Products Corp. · Oct 1989
ORTHO RESULT PLUS/PREGNANCY
K894420 · Ortho Diagnostic Systems, Inc. · Oct 1989
IMX TOTAL B-HCG
K894182 · Abbott Laboratories · Sep 1989