Cleared Traditional

K934550 - IMMUNOCARD MYCOPLASMA

K934550 is the FDA 510(k) clearance for IMMUNOCARD MYCOPLASMA by Meridian Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LJZ) cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K934550 · Meridian Diagnostics, Inc. · Microbiology device
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Sep 1994
Decision
363d
Days
Class 1
Risk

K934550 is an FDA 510(k) clearance for the IMMUNOCARD MYCOPLASMA. Classified as Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K934550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1993
Decision Date September 20, 1994
Days to Decision 363 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
261d slower than avg
Panel avg: 102d · This submission: 363d
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.

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 K934550.
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
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