Cleared Traditional

RESUBMITTED ABBOTT TESTPACK ROTAVIRUS (K880821) - FDA 510(k) Clearance

Class I Microbiology device.

K880821 · Abbott Laboratories · Microbiology device
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May 1988
Decision
66d
Days
Class 1
Risk

K880821 is an FDA 510(k) clearance for the RESUBMITTED ABBOTT TESTPACK ROTAVIRUS. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 66 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 Abbott Laboratories devices

Submission Details

510(k) Number K880821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 06, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 102d · This submission: 66d
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

Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K880821.
ROTACUBE
K884017 · Difco Laboratories, Inc. · Jan 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935 · Ortho Diagnostic Systems, Inc. · Jan 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · Ortho Diagnostic Systems, Inc. · Jan 1989
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · Abbott Laboratories · Dec 1987
ENZYGNOST ROTAVIRUS AG
K841243 · Behring Diagnostics, Inc. · Oct 1984