Cleared Traditional

K971585 - IMMUNOCARD STAT! ROTAVIRUS (FDA 510(k) Clearance)

Class I Microbiology device.

K971585 · Meridian Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
111d
Days
Class 1
Risk

K971585 is an FDA 510(k) clearance for the IMMUNOCARD STAT! ROTAVIRUS. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 20, 1997 after a review of 111 days - within the typical 510(k) review window.

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 Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K971585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date August 20, 1997
Days to Decision 111 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 102d · This submission: 111d
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.