Cleared Traditional

K934550 - IMMUNOCARD MYCOPLASMA

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

K934550 · Meridian Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K934550

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.

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.

All 8
Devices cleared under the same product code (LJZ) and FDA review panel - the closest regulatory comparables to K934550.
MYCOPLASMA IGG ELISA TEST SYSTEM
K970150 · Zeus Scientific, Inc. · Jun 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
K963054 · Genbio · May 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
K963055 · Genbio · May 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