Cleared Traditional

K873740 - ROTASCREEN EIA

K873740 is the FDA 510(k) clearance for ROTASCREEN EIA by Mercia Diagnostics , Ltd.. It is a Class 1 Microbiology device (product code LIQ) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K873740 · Mercia Diagnostics , Ltd. · Microbiology device
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Nov 1987
Decision
73d
Days
Class 1
Risk

K873740 is an FDA 510(k) clearance for the ROTASCREEN EIA. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on November 27, 1987 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - the FDA microbiology 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 Mercia Diagnostics , Ltd. devices

Submission Details

510(k) Number K873740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date November 27, 1987
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

All 19
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K873740.
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · Ortho Diagnostic Systems, Inc. · Jan 1989
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · Abbott Laboratories · May 1988
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · Abbott Laboratories · Dec 1987
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · Kallestad Laboratories, Inc. · Oct 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · Bartels Immunodiagnostic Supplies, Inc. · Jul 1986
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · Kallestad Laboratories, Inc. · Nov 1985