Cleared Traditional

K883182 - FIAGEN RUBELLA IGG

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

K883182 · Cyberfluor, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K883182

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
Combination Product No
PCCP Authorized No
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.

LFX Device Classification - Class 2, Special Controls

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 79
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K883182.
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617 · Ortho Diagnostic Systems, Inc. · Feb 1989
IMMUNODOT RUBELLA TEST
K885082 · General Biometrics, 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
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
K881243 · Labsystems, Inc. · Apr 1988