Cleared Traditional

K955360 - INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ...

K955360 is the FDA 510(k) clearance for INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ... by Incstar Corp.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K955360 · Incstar Corp. · Microbiology device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
243d
Days
Class 2
Risk

K955360 is an FDA 510(k) clearance for the INCSTAR CYTOMEGALOVIRUS IGG FAST 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 K955360 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
Combination Product No
PCCP Authorized No
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 42
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K955360.
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · Incstar Corp. · Oct 1996
OPUS CMV TEST SYSTEM-MODIFICATION
K963084 · Behring Diagnostics, Inc. · Oct 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943 · Abbott Laboratories · Sep 1996
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · Incstar Corp. · Jul 1996
IMMULITE CMV IGG
K950672 · Diagnostic Products Corp. · Jun 1996
OPUS CMV-G
K933389 · Pb Diagnostic Systems, Inc. · Jun 1994