Cleared Special

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 (K992252) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992252 · Chemicon Intl., Inc. · Microbiology device
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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.

View all Chemicon Intl., Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.