Cleared Special

K992252 - LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965

K992252 is an FDA 510(k) clearance for LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, manufactured by Chemicon Intl., Inc.. The device is a Class 2 Microbiology device with product code LYF cleared through the Special 510(k) pathway after a 35-day FDA review.

K992252 · Chemicon Intl., Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
35d
Days
Class 2
Risk

K992252 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965. Classified as Pneumocystis Carinii (product code LYF), Class II - Special Controls.

Submitted by Chemicon Intl., Inc. (Temecula, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K992252

510(k) Number K992252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1999
Decision Date August 10, 1999
Days to Decision 35 days
Submission Type Special
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
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 K992252.
FUNGI FLUOR KIT
K923349 · Polysciences, Inc. · Oct 1992
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
K905504 · Dako Corp. · Jun 1991
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
K904400 · Meridian Diagnostics, Inc. · Oct 1990
PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
K890768 · Genetic Systems Corp. · Mar 1989
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
K884047 · Disease Detection International, Inc. · Mar 1989
MERIFLUOR(TM) PNEUMOCYSTIS
K881608 · Meridian Diagnostics, Inc. · Aug 1988
K992252 · LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
Download PDF Chemicon Intl., Inc.