Cleared Traditional

INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY (K955361) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955361 · Incstar Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
243d
Days
Class 2
Risk

K955361 is an FDA 510(k) clearance for the INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 243 days - an extended review cycle.

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. 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 Incstar Corp. devices

Submission Details

510(k) Number K955361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1995
Decision Date July 22, 1996
Days to Decision 243 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 102d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K955361.
Architect CMV IgG
K220949 · Abbott Laboratories · Oct 2022
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K220911 · Roche Diagnostics · Oct 2022
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · Siemens Healthcare Diagnostics, Inc. · Jul 2018
Elecsys CMV IgM
K163569 · Roche Diagnostics · Mar 2017
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · Diagnostic Products Corp. · Dec 1999
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · Abbott Laboratories · Mar 1997