Cleared Traditional

K954318 - ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY

K954318 is an FDA 510(k) clearance for ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K954318 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
242d
Days
Class 2
Risk

K954318 is an FDA 510(k) clearance for the ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 14, 1996 after a review of 242 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K954318

510(k) Number K954318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date May 14, 1996
Days to Decision 242 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 102d · This submission: 242d
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 65
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K954318.
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · Abbott Laboratories · Sep 1996
SERAQUEST RUBELLA IGG
K961053 · Quest Intl., Inc. · Sep 1996
IMX RUBELLA IGG
K951541 · Abbott Laboratories · Jul 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · Bayer Corp. · Apr 1996
ACCESS RUBELLA IGG
K954687 · Bio-Rad Laboratories, Inc. · Apr 1996
RUBELLA IGG ELISA TEST
K941624 · Gull Laboratories, Inc. · Aug 1995