Cleared Traditional

K901484 - LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUN...

K901484 is the FDA 510(k) clearance for LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUN... by London Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K901484 · London Diagnostics, Inc. · Chemistry device
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May 1990
Decision
33d
Days
Class 2
Risk

K901484 is an FDA 510(k) clearance for the LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by London Diagnostics, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 1, 1990 after a review of 33 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 London Diagnostics, Inc. devices

Submission Details

510(k) Number K901484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date May 01, 1990
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
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 K901484.
AFFINITY HCG TEST SYSTEM
K902720 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
KODAK SURECELL(TM) HCG-URINE TEST KIT
K902136 · Eastman Kodak Company · Jun 1990
OPUS (TM) HCG
K901935 · Pb Diagnostic Systems, Inc. · Jun 1990
IMX HCG (LIST #03A63)
K900327 · Abbott Laboratories · Apr 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587 · Medix Biotech, Inc. · Feb 1990