Cleared Traditional

K963054 - IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)

K963054 is an FDA 510(k) clearance for IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBOD..., manufactured by Genbio. The device is a Class 1 Microbiology device with product code LJZ cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K963054 · Genbio · Microbiology device
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May 1997
Decision
272d
Days
Class 1
Risk

K963054 is an FDA 510(k) clearance for the IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130). Classified as Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ), Class I - General Controls.

Submitted by Genbio (San Diego, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 272 days - an extended review cycle.

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 Genbio devices

FDA 510(k) Submission Details - K963054

510(k) Number K963054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1996
Decision Date May 05, 1997
Days to Decision 272 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 102d · This submission: 272d
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 7
Devices cleared under the same product code (LJZ) and FDA review panel - the closest regulatory comparables to K963054.
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · Zeus Scientific, Inc. · Aug 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · Immunoprobe, Inc. · Jul 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