Cleared Traditional

K881608 - MERIFLUOR(TM) PNEUMOCYSTIS

K881608 is an FDA 510(k) clearance for MERIFLUOR(TM) PNEUMOCYSTIS, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LYF cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K881608 · Meridian Diagnostics, Inc. · Microbiology device
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Aug 1988
Decision
114d
Days
Class 2
Risk

K881608 is an FDA 510(k) clearance for the MERIFLUOR(TM) PNEUMOCYSTIS. Classified as Pneumocystis Carinii (product code LYF), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 4, 1988 after a review of 114 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K881608

510(k) Number K881608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1988
Decision Date August 04, 1988
Days to Decision 114 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 102d · This submission: 114d
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.