Cleared Traditional

K001875 - DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SY...

K001875 is the FDA 510(k) clearance for DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SY... by Diamedix Corp.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K001875 · Diamedix Corp. · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
62d
Days
Class 2
Risk

K001875 is an FDA 510(k) clearance for the DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on August 21, 2000 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diamedix Corp. devices

Submission Details

510(k) Number K001875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2000
Decision Date August 21, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 102d · This submission: 62d
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 59
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K001875.
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077 · Diagnostic Products Corp. · Jan 2002
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · Bayer Corp. · Jul 2001
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · Bayer Corp. · Apr 2001
COPALIS RUBELLA IGM
K993291 · DiaSorin, Inc. · Feb 2000
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · Zeus Scientific, Inc. · Jul 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
K983805 · Zeus Scientific, Inc. · May 1999