Cleared Traditional

K960434 - INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELI...

K960434 is the FDA 510(k) clearance for INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELI... by Incstar Corp.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K960434 · Incstar Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
260d
Days
Class 2
Risk

K960434 is an FDA 510(k) clearance for the INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530. 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 October 17, 1996 after a review of 260 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 K960434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1996
Decision Date October 17, 1996
Days to Decision 260 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
158d slower than avg
Panel avg: 102d · This submission: 260d
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 K960434.
QUANTA LITE CMV IGG ELISA
K971335 · Inova Diagnostics, Inc. · Dec 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · Abbott Laboratories · Mar 1997
HEMAGEN CMV IGG KIT
K944438 · Hemagen Diagnostics, Inc. · Feb 1997
OPUS CMV TEST SYSTEM-MODIFICATION
K963084 · Behring Diagnostics, Inc. · Oct 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943 · Abbott Laboratories · Sep 1996
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
K955360 · Incstar Corp. · Jul 1996