Cleared Traditional

K946158 - INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT

K946158 is an FDA 510(k) clearance for INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (E..., manufactured by Incstar Corp.. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K946158 · Incstar Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
183d
Days
Class 1
Risk

K946158 is an FDA 510(k) clearance for the INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on June 9, 1995 after a review of 183 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 - K946158

510(k) Number K946158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1994
Decision Date June 09, 1995
Days to Decision 183 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
81d slower than avg
Panel avg: 102d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

LLM Device Classification - Class 1, General Controls

Product Code LLM Test, Antigen, Nuclear, Epstein-barr Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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.

Regulatory Peers - LLM Test, Antigen, Nuclear, Epstein-barr Virus

All 21
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K946158.
EBNA IGG EIA TEST SYSTEM
K951549 · Immunoprobe, Inc. · Apr 1996
EBNA ENZYME IMMUNOASSAY KIT
K951822 · Granbio, Inc. · Feb 1996
EBNA IGG ELISA TEST
K935730 · Gull Laboratories, Inc. · Sep 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · Zeus Scientific, Inc. · May 1995
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
K930002 · Ortho Diagnostic Systems, Inc. · Jul 1993
EBNA STAT TEST KIT
K911473 · Whittaker Bioproducts, Inc. · Sep 1991