Cleared Traditional

K883182 - FIAGEN RUBELLA IGG

K883182 is the FDA 510(k) clearance for FIAGEN RUBELLA IGG by Cyberfluor, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K883182 · Cyberfluor, Inc. · Microbiology device
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Oct 1988
Decision
95d
Days
Class 2
Risk

K883182 is an FDA 510(k) clearance for the FIAGEN RUBELLA IGG. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on October 31, 1988 after a review of 95 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 Cyberfluor, Inc. devices

Submission Details

510(k) Number K883182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date October 31, 1988
Days to Decision 95 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 102d · This submission: 95d
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 63
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K883182.
RUBELLA-CUBE(TM)
K892051 · Difco Laboratories, Inc. · Jun 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617 · Ortho Diagnostic Systems, Inc. · Feb 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
VIRGO(TM) RUBELLA IGG ELISA
K873088 · Electro-Nucleonics Laboratories, Inc. · Sep 1987