Cleared Traditional

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM (K950073) - FDA 510(k) Clearance

Class I Microbiology device.

K950073 · Shared Systems, Inc. · Microbiology device
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Oct 1995
Decision
281d
Days
Class 1
Risk

K950073 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM. Classified as Antisera, All Mycoplasma Spp. (product code GSA), Class I - General Controls.

Submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on October 17, 1995 after a review of 281 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 Shared Systems, Inc. devices

Submission Details

510(k) Number K950073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1995
Decision Date October 17, 1995
Days to Decision 281 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
179d slower than avg
Panel avg: 102d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GSA Antisera, All 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.