Cleared Traditional

K864811 - ROTA-STAT

K864811 is the FDA 510(k) clearance for ROTA-STAT by Intl. Diagnostic Laboratories, Ltd.. It is a Class 1 Microbiology device (product code LIQ) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K864811 · Intl. Diagnostic Laboratories, Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
259d
Days
Class 1
Risk

K864811 is an FDA 510(k) clearance for the ROTA-STAT. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Intl. Diagnostic Laboratories, Ltd. (Israel, IL). The FDA issued a Cleared decision on August 25, 1987 after a review of 259 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Diagnostic Laboratories, Ltd. devices

Submission Details

510(k) Number K864811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date August 25, 1987
Days to Decision 259 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 102d · This submission: 259d
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 K864811.
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