Cleared Traditional

K945487 - LYFO(TM) DIFFERENTIAL DISK

K945487 is an FDA 510(k) clearance for LYFO(TM) DIFFERENTIAL DISK, manufactured by Microbiologics, Inc.. The device is a Class 1 Microbiology device with product code JSP cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K945487 · Microbiologics, Inc. · Microbiology device
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May 1995
Decision
184d
Days
Class 1
Risk

K945487 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK. Classified as Kit, Anaerobic Identification (product code JSP), Class I - General Controls.

Submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on May 11, 1995 after a review of 184 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Microbiologics, Inc. devices

FDA 510(k) Submission Details - K945487

510(k) Number K945487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date May 11, 1995
Days to Decision 184 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 102d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

JSP Device Classification - Class 1, General Controls

Product Code JSP Kit, Anaerobic Identification
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JSP Kit, Anaerobic Identification

All 13
Devices cleared under the same product code (JSP) and FDA review panel - the closest regulatory comparables to K945487.
LYFO(TM) DIFFERENTIAL DISK
K945488 · Microbiologics, Inc. · May 1995
LYFO(TM) DIFFERENTIAL DISK
K945489 · Microbiologics, Inc. · May 1995
BBLCRYSTAL ANAEROBE ID SYSTEM
K944528 · Becton Dickinson Microbiology Systems · Mar 1995
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
K910666 · Vitek Systems, Inc. · Apr 1991
VITEK ANAEROBE IDENTIFICATION CARD
K900996 · Vitek Systems, Inc. · May 1990
DIAGNOSTIC REAGENT PET-RPLA
K855235 · Oxoid U.S.A., Inc. · Nov 1986