Cleared Traditional

K955363 - INCSTAR HSZ I/II IGG ELISA ASSAY

K955363 is an FDA 510(k) clearance for INCSTAR HSZ I/II IGG ELISA ASSAY, manufactured by Incstar Corp.. The device is a Class 1 Microbiology device with product code IGC cleared through the Traditional 510(k) pathway after a 245-day FDA review.

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

FDA 510(k) Submission Details - K955363

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 102d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

IGC Device Classification - Class 1, General Controls

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.