Cleared Traditional

K953943 - AXSYM CMV IGG ANTIBODY ASSAY

K953943 is an FDA 510(k) clearance for AXSYM CMV IGG ANTIBODY ASSAY, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K953943 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
396d
Days
Class 2
Risk

K953943 is an FDA 510(k) clearance for the AXSYM CMV IGG ANTIBODY ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 20, 1996 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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. Elevated predicate reliance profile. 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 - K953943

510(k) Number K953943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1995
Decision Date September 20, 1996
Days to Decision 396 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
294d slower than avg
Panel avg: 102d · This submission: 396d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFZ Device Classification - Class 2, Special Controls

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 44
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K953943.
HEMAGEN CMV IGG KIT
K944438 · Hemagen Diagnostics, Inc. · Feb 1997
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · Incstar Corp. · Oct 1996
OPUS CMV TEST SYSTEM-MODIFICATION
K963084 · Behring Diagnostics, Inc. · Oct 1996
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
K955360 · Incstar Corp. · Jul 1996
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · Incstar Corp. · Jul 1996
IMMULITE CMV IGG
K950672 · Diagnostic Products Corp. · Jun 1996