Cleared Traditional

K904501 - MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM

K904501 is an FDA 510(k) clearance for MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM, manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 1 Microbiology device with product code LJZ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K904501 · Medical Diagnostic Technologies, Inc. · Microbiology device
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Feb 1991
Decision
147d
Days
Class 1
Risk

K904501 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (product code LJZ), Class I - General Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Augusta, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 147 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 Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K904501

510(k) Number K904501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date February 26, 1991
Days to Decision 147 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 102d · This submission: 147d
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.