Cleared Traditional

OPUS(R) SEROLOGY CONTROLS, MODIFICATION (K934137) - FDA 510(k) Clearance

Class I Microbiology device.

K934137 · Pb Diagnostic Systems, Inc. · Microbiology device
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Mar 1994
Decision
194d
Days
Class 1
Risk

K934137 is an FDA 510(k) clearance for the OPUS(R) SEROLOGY CONTROLS, MODIFICATION. Classified as Kit, Serological, Positive Control (product code MJX), Class I - General Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 194 days - an extended review cycle.

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 Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K934137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date March 07, 1994
Days to Decision 194 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
92d slower than avg
Panel avg: 102d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.