Cleared Traditional

K983762 - NUCLISENS CMV PP67 (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983762 · Organon Teknika Corp. · Microbiology device
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Sep 1999
Decision
324d
Days
Class 2
Risk

K983762 is an FDA 510(k) clearance for the NUCLISENS CMV PP67. Classified as Antisera, Conjugated Fluorescent, Cytomegalovirus (product code LIN), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on September 15, 1999 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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. Elevated predicate reliance profile. 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K983762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1998
Decision Date September 15, 1999
Days to Decision 324 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
222d slower than avg
Panel avg: 102d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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.