Cleared Traditional

K862262 - HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT...

K862262 is the FDA 510(k) clearance for HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT... by Serono Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K862262 · Serono Diagnostics, Inc. · Chemistry device
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Jul 1986
Decision
46d
Days
Class 2
Risk

K862262 is an FDA 510(k) clearance for the HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on July 29, 1986 after a review of 46 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K862262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1986
Decision Date July 29, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K862262.
VIS-CUBE HCG (EIA)
K863933 · Leeco Diagnostics, Inc. · Dec 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861 · Hybritech, Inc. · Nov 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · Abbott Laboratories · Sep 1986
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
K860490 · Medix Biotech, Inc. · Mar 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542 · Hybritech, Inc. · Mar 1986
LBK 1244 DELFIA HCG KIT
K852760 · Lkb Instruments, Inc. · Dec 1985