Cleared Traditional

K913080 - OPUS(R) ANTI CMV-M (FDA 510(k) Clearance)

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

K913080 · Pb Diagnostics, Inc. · Microbiology device
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Oct 1991
Decision
109d
Days
Class 2
Risk

K913080 is an FDA 510(k) clearance for the OPUS(R) ANTI CMV-M. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on October 28, 1991 after a review of 109 days - within the typical 510(k) review window.

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. 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 Pb Diagnostics, Inc. devices

Submission Details

510(k) Number K913080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1991
Decision Date October 28, 1991
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 102d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKQ Antibody Igm,if, Cytomegalovirus Virus
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.