Cleared Traditional

K844082 - QUEST BETA HCG ENZYME IMMUNOASSAY KIT

K844082 is an FDA 510(k) clearance for QUEST BETA HCG ENZYME IMMUNOASSAY KIT, manufactured by Quidel Corp.. The device is a Class 2 Immunology device with product code JHI cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K844082 · Quidel Corp. · Immunology device
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Nov 1984
Decision
33d
Days
Class 2
Risk

K844082 is an FDA 510(k) clearance for the QUEST BETA HCG ENZYME IMMUNOASSAY KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Quidel Corp. (La Jolla, US). The FDA issued a Cleared decision on November 21, 1984 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - the FDA immunology device 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 - K844082

510(k) Number K844082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1984
Decision Date November 21, 1984
Days to Decision 33 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 105d · This submission: 33d
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 Immunology 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 K844082.
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
K850159 · Hybritech, Inc. · Mar 1985
LEECO CONCEP-7-BHCG LEIAD II
K850201 · Leeco Diagnostics, Inc. · Mar 1985
CONCEP-7-BHCG (EIA)
K844153 · Leeco Diagnostics, Inc. · Dec 1984
BETA QUIK V
K843795 · Pacific Biotech, Inc. · Oct 1984
ENCORE HCG REAGENT
K843407 · Hybritech, Inc. · Oct 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654 · Beckman Instruments, Inc. · Oct 1984