Cleared Traditional

K951822 - EBNA ENZYME IMMUNOASSAY KIT

K951822 is an FDA 510(k) clearance for EBNA ENZYME IMMUNOASSAY KIT, manufactured by Granbio, Inc.. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K951822 · Granbio, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
301d
Days
Class 1
Risk

K951822 is an FDA 510(k) clearance for the EBNA ENZYME IMMUNOASSAY KIT. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on February 15, 1996 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Granbio, Inc. devices

FDA 510(k) Submission Details - K951822

510(k) Number K951822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date February 15, 1996
Days to Decision 301 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
199d slower than avg
Panel avg: 102d · This submission: 301d
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 K951822.
IMMUNOWELL EBNA IGG TEST
K973941 · Genbio · Aug 1998
EBNA-1 IGM ELISA TEST SYSTEM
K980598 · Clark Laboratories, Inc. · May 1998
EBNA IGG EIA TEST SYSTEM
K951549 · Immunoprobe, Inc. · Apr 1996
EBNA IGG ELISA TEST
K935730 · Gull Laboratories, Inc. · Sep 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · Incstar Corp. · Jun 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · Zeus Scientific, Inc. · May 1995