Cleared Traditional

K843407 - ENCORE HCG REAGENT

K843407 is the FDA 510(k) clearance for ENCORE HCG REAGENT by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K843407 · Hybritech, Inc. · Chemistry device
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Oct 1984
Decision
34d
Days
Class 2
Risk

K843407 is an FDA 510(k) clearance for the ENCORE HCG REAGENT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 34 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 Hybritech, Inc. devices

Submission Details

510(k) Number K843407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date October 04, 1984
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K843407.
LEECO CONCEP-7-BHCG LEIAD II
K850201 · Leeco Diagnostics, Inc. · Mar 1985
CONCEP-7-BHCG (EIA)
K844153 · Leeco Diagnostics, Inc. · Dec 1984
QUEST BETA HCG ENZYME IMMUNOASSAY KIT
K844082 · Quidel Corp. · Nov 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654 · Beckman Instruments, Inc. · Oct 1984
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT
K842692 · Quidel Corp. · Sep 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633 · Hybritech, Inc. · Aug 1984