Cleared Traditional

K983762 - NUCLISENS CMV PP67

K983762 is an FDA 510(k) clearance for NUCLISENS CMV PP67, manufactured by Organon Teknika Corp.. The device is a Class 2 Microbiology device with product code LIN cleared through the Traditional 510(k) pathway after a 324-day FDA review.

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

FDA 510(k) Submission Details - K983762

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
Combination Product No
PCCP Authorized No
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.

LIN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

All 11
Devices cleared under the same product code (LIN) and FDA review panel - the closest regulatory comparables to K983762.
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K912592 · Gull Laboratories, Inc. · Dec 1991
OPUS CMV TEST SYSTEM
K905257 · Pb Diagnostic Systems, Inc. · Apr 1991
BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN
K904036 · Baxter Healthcare Corp · Oct 1990