Cleared Traditional

K890768 - PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT

K890768 is an FDA 510(k) clearance for PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE..., manufactured by Genetic Systems Corp.. The device is a Class 2 Microbiology device with product code LYF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K890768 · Genetic Systems Corp. · Microbiology device
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Mar 1989
Decision
34d
Days
Class 2
Risk

K890768 is an FDA 510(k) clearance for the PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT. Classified as Pneumocystis Carinii (product code LYF), Class II - Special Controls.

Submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on March 21, 1989 after a review of 34 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Genetic Systems Corp. devices

FDA 510(k) Submission Details - K890768

510(k) Number K890768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1989
Decision Date March 21, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 102d · This submission: 34d
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 K890768.
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