Cleared Traditional

K971393 - MYCOPLASMA IGG ELISA TEST SYSTEM

K971393 is an FDA 510(k) clearance for MYCOPLASMA IGG ELISA TEST SYSTEM, manufactured by Immunoprobe, Inc.. The device is a Class 1 Microbiology device with product code LJZ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K971393 · Immunoprobe, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971393

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 102d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

LJZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Devices cleared under the same product code (LJZ) and FDA review panel - the closest regulatory comparables to K971393.
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K984153 · Zeus Scientific, Inc. · Jan 1999
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · Zeus Scientific, Inc. · Aug 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K970150 · Zeus Scientific, Inc. · Jun 1997
IMMUNOCARD MYCOPLASMA
K934550 · Meridian Diagnostics, Inc. · Sep 1994
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
K921556 · Medical Diagnostic Technologies, Inc. · Jun 1992
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
K904501 · Medical Diagnostic Technologies, Inc. · Feb 1991