Cleared Traditional

K933389 - OPUS CMV-G

K933389 is an FDA 510(k) clearance for OPUS CMV-G, manufactured by Pb Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K933389 · Pb Diagnostic Systems, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K933389

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
Combination Product No
PCCP Authorized No
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.

LFZ Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K933389.
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · Incstar Corp. · Jul 1996
IMMULITE CMV IGG
K950672 · Diagnostic Products Corp. · Jun 1996
SERAQUEST CMV IGG
K954191 · Quest Intl., Inc. · Feb 1996
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582 · Baxter Diagnostics, Inc. · Apr 1993
CMV ELISA TEST SYSTEM
K924096 · Zeus Scientific, Inc. · Apr 1993
VIDAS CMV IGG ASSAY
K920661 · Vitek Systems, Inc. · Feb 1993