Cleared Traditional

K950073 - MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM

K950073 is an FDA 510(k) clearance for MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AG..., manufactured by Shared Systems, Inc.. The device is a Class 1 Microbiology device with product code GSA cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K950073 · Shared Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K950073

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.

GSA Device Classification - Class 1, General Controls

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.

Regulatory Peers - GSA Antisera, All Mycoplasma Spp.

Devices cleared under the same product code (GSA) and FDA review panel - the closest regulatory comparables to K950073.
COLOR VUE TM- MYCOPLASMA PNEUMONIAE
K910833 · Seradyn, Inc. · Jun 1991
MERISTAR-MP
K905493 · Meridian Diagnostics, Inc. · Jan 1991
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K883083 · Medical Diagnostic Technologies, Inc. · Oct 1988
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K862630 · Medical Diagnostic Technologies, Inc. · Sep 1986