Cleared Traditional

MYCOPLASMA IGG ELISA TEST SYSTEM (K971393) - FDA 510(k) Clearance

Class I Microbiology device.

K971393 · Immunoprobe, Inc. · Microbiology device
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Jul 1997
Decision
96d
Days
Class 1
Risk

K971393 is an FDA 510(k) clearance for the MYCOPLASMA IGG ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ), Class I - General Controls.

Submitted by Immunoprobe, Inc. (Frederick, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3375 - 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 K971393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1997
Decision Date July 14, 1997
Days to Decision 96 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
6d faster than avg
Panel avg: 102d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3375
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.