Cleared Traditional

K884617 - ORTHO RESULT PLUS/RUBELLA RAPID COLOR. ...

K884617 is the FDA 510(k) clearance for ORTHO RESULT PLUS/RUBELLA RAPID COLOR. ... by Ortho Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K884617 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Feb 1989
Decision
90d
Days
Class 2
Risk

K884617 is an FDA 510(k) clearance for the ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on February 2, 1989 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K884617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date February 02, 1989
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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 K884617.
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · Abbott Laboratories · Jun 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · Abbott Laboratories · Jun 1989
RUBELLA-CUBE(TM)
K892051 · Difco Laboratories, Inc. · Jun 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
K882999 · Organon Teknika Corp. · Jan 1989
RUBELLA IGM MICROASSAY
K883778 · Diamedix Corp. · Oct 1988
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475 · Amersham Corp. · Oct 1988