Cleared Traditional

K923349 - FUNGI FLUOR KIT

K923349 is an FDA 510(k) clearance for FUNGI FLUOR KIT, manufactured by Polysciences, Inc.. The device is a Class 2 Microbiology device with product code LYF cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K923349 · Polysciences, Inc. · Microbiology device
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Oct 1992
Decision
104d
Days
Class 2
Risk

K923349 is an FDA 510(k) clearance for the FUNGI FLUOR KIT. Classified as Pneumocystis Carinii (product code LYF), Class II - Special Controls.

Submitted by Polysciences, Inc. (Warrington, US). The FDA issued a Cleared decision on October 20, 1992 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - 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 Polysciences, Inc. devices

FDA 510(k) Submission Details - K923349

510(k) Number K923349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1992
Decision Date October 20, 1992
Days to Decision 104 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 102d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYF Device Classification - Class 2, Special Controls

Product Code LYF Pneumocystis Carinii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LYF Pneumocystis Carinii

Devices cleared under the same product code (LYF) and FDA review panel - the closest regulatory comparables to K923349.
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
K992252 · Chemicon Intl., Inc. · Aug 1999
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
K905504 · Dako Corp. · Jun 1991
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
K904400 · Meridian Diagnostics, Inc. · Oct 1990
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
K884047 · Disease Detection International, Inc. · Mar 1989
MERIFLUOR(TM) PNEUMOCYSTIS
K881608 · Meridian Diagnostics, Inc. · Aug 1988