Cleared Traditional

OPUS CMV-G (K933389) - FDA 510(k) Clearance

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

K933389 · Pb Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
351d
Days
Class 2
Risk

K933389 is an FDA 510(k) clearance for the OPUS CMV-G. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on June 28, 1994 after a review of 351 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K933389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date June 28, 1994
Days to Decision 351 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
249d slower than avg
Panel avg: 102d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, 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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 57
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K933389.
Architect CMV IgG
K220949 · Abbott Laboratories · Oct 2022
Elecsys CMV IgG
K220911 · Roche Diagnostics · Oct 2022
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · Siemens Healthcare Diagnostics, Inc. · Jul 2018
Elecsys CMV IgM
K163569 · Roche Diagnostics · Mar 2017
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · Diagnostic Products Corp. · Dec 1999
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · Abbott Laboratories · Mar 1997