Cleared Traditional

K955360 - INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY

K955360 is an FDA 510(k) clearance for INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ..., manufactured by Incstar Corp.. The device is a Class 2 Microbiology device with 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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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

FDA 510(k) Submission Details - K955360

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.

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 50
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
SERAQUEST CMV IGG
K954191 · Quest Intl., Inc. · Feb 1996