Cleared Traditional

INCSTAR HSZ I/II IGG ELISA ASSAY (K955363) - FDA 510(k) Clearance

Class I Microbiology device.

K955363 · Incstar Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
245d
Days
Class 1
Risk

K955363 is an FDA 510(k) clearance for the INCSTAR HSZ I/II IGG ELISA ASSAY. Classified as Formalin-saline (product code IGC), Class I - General Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on July 24, 1996 after a review of 245 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.4010 - 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 K955363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1995
Decision Date July 24, 1996
Days to Decision 245 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
143d slower than avg
Panel avg: 102d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IGC Formalin-saline
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.