Cleared Traditional

K925355 - BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY ...

K925355 is the FDA 510(k) clearance for BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY ... by Princeton Biomedix. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 628-day FDA review.

K925355 · Princeton Biomedix · Microbiology device
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Jul 1994
Decision
628d
Days
Class 2
Risk

K925355 is an FDA 510(k) clearance for the BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Princeton Biomedix (Princeton, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 628 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Princeton Biomedix devices

Submission Details

510(k) Number K925355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date July 12, 1994
Days to Decision 628 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
526d slower than avg
Panel avg: 102d · This submission: 628d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 64
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K925355.
ACCESS RUBELLA IGG
K954687 · Bio-Rad Laboratories, Inc. · Apr 1996
RUBELLA IGG ELISA TEST
K941624 · Gull Laboratories, Inc. · Aug 1995
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · Abbott Laboratories · Dec 1994
BARTELS RUBELLA IGM EIA
K922581 · Baxter Diagnostics, Inc. · Sep 1992
BARTELS RUBELLA IGG EIA
K922586 · Baxter Diagnostics, Inc. · Sep 1992
RUBELLA IGM ELISA TEST SYSTEM
K914028 · Zeus Scientific, Inc. · Apr 1992