Cleared Traditional

ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (K972406) - FDA 510(k) Clearance

Class I Microbiology device.

K972406 · Immunoprobe, Inc. · Microbiology device
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Dec 1997
Decision
179d
Days
Class 1
Risk

K972406 is an FDA 510(k) clearance for the ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM. Classified as Antigens, Cf (including Cf Control), Adenovirus 1-33 (product code GOD), Class I - General Controls.

Submitted by Immunoprobe, Inc. (Frederick, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 179 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3020 - 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 Immunoprobe, Inc. devices

Submission Details

510(k) Number K972406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date December 22, 1997
Days to Decision 179 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
77d slower than avg
Panel avg: 102d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GOD Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3020
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.