Cleared Traditional

ENZYGNOST TM RUBELLA IGM (K813493) - FDA 510(k) Clearance

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

K813493 · Calbiochem-Behring Corp. · Immunology device
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Mar 1982
Decision
80d
Days
Class 2
Risk

K813493 is an FDA 510(k) clearance for the ENZYGNOST TM RUBELLA IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3510 - the FDA immunology 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 Calbiochem-Behring Corp. devices

Submission Details

510(k) Number K813493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1981
Decision Date March 04, 1982
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 104d · This submission: 80d
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 Immunology 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 K813493.
Access Rubella IgG
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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