Cleared Traditional

K841200 - RUBELLA IGG ANTIBODY ELISA TEST SYS

K841200 is the FDA 510(k) clearance for RUBELLA IGG ANTIBODY ELISA TEST SYS by Ortho Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K841200 · Ortho Diagnostic Systems, Inc. · Microbiology device
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May 1984
Decision
61d
Days
Class 2
Risk

K841200 is an FDA 510(k) clearance for the RUBELLA IGG ANTIBODY ELISA TEST SYS. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on May 21, 1984 after a review of 61 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K841200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1984
Decision Date May 21, 1984
Days to Decision 61 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 102d · This submission: 61d
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 62
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K841200.
RUBELLA MICROASSAY
K864602 · Diamedix Corp. · Apr 1987
CORDOT R
K854618 · Cordis Corp. · May 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · Hybritech, Inc. · Jan 1986
ORTHO RUBELLA ELISA TEST SYSTEM
K822342 · Ortho Diagnostic Systems, Inc. · Mar 1983
ENZYGNOST TM RUBELLA IGM
K813493 · Calbiochem-Behring Corp. · Mar 1982
ROTAZYME
K791746 · Abbott Laboratories · Nov 1979