Cleared Traditional

BIOTROL RUB-E.I.A. TEST G (K894544) - FDA 510(k) Clearance

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

K894544 · Biotrol, USA, Inc. · Microbiology device
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Aug 1989
Decision
41d
Days
Class 2
Risk

K894544 is an FDA 510(k) clearance for the BIOTROL RUB-E.I.A. TEST G. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Westchester, US). The FDA issued a Cleared decision on August 30, 1989 after a review of 41 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K894544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date August 30, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
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 93
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K894544.
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K250588 · Beckman Coulter, Inc. · Nov 2025
Alinity i Rubella IgG
K243168 · Abbott Laboratories · Jun 2025
VIDAS RUB IGG
K080766 · bioMerieux, Inc. · Dec 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · Roche Diagnostics Corp. · Dec 2008
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · Beckman Coulter, Inc. · Jun 2003
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
K012077 · Diagnostic Products Corp. · Jan 2002