Cleared Traditional

K925703 - OPUS SEROLOGY CONTROLS

K925703 is an FDA 510(k) clearance for OPUS SEROLOGY CONTROLS, manufactured by Pb Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code MJX cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K925703 · Pb Diagnostics, Inc. · Microbiology device
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Apr 1993
Decision
147d
Days
Class 1
Risk

K925703 is an FDA 510(k) clearance for the OPUS SEROLOGY CONTROLS. Classified as Kit, Serological, Positive Control (product code MJX), Class I - General Controls.

Submitted by Pb Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - 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

FDA 510(k) Submission Details - K925703

510(k) Number K925703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date April 08, 1993
Days to Decision 147 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
45d slower than avg
Panel avg: 102d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

MJX Device Classification - Class 1, General Controls

Product Code MJX Kit, Serological, Positive Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.