Cleared Traditional

K896347 - IMMUNODOT AUTOIMMUNE SCREENING PANEL 1

K896347 is an FDA 510(k) clearance for IMMUNODOT AUTOIMMUNE SCREENING PANEL 1, manufactured by General Biometrics, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K896347 · General Biometrics, Inc. · Immunology device
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Dec 1989
Decision
32d
Days
Class 2
Risk

K896347 is an FDA 510(k) clearance for the IMMUNODOT AUTOIMMUNE SCREENING PANEL 1. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 5, 1989 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Biometrics, Inc. devices

FDA 510(k) Submission Details - K896347

510(k) Number K896347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1989
Decision Date December 05, 1989
Days to Decision 32 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 104d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 Immunology devices follow this clearance model.

Regulatory Peers - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 58
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K896347.
DIASTAT ENA PROFILE
K905190 · Shield Diagnostics, Ltd. · Dec 1990
ANTI-SCI-70 MICROASSAY
K902915 · Diamedix Corp. · Sep 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072 · General Biometrics, Inc. · Jan 1990
ANTI-SM MICROASSAY
K894894 · Diamedix Corp. · Aug 1989
DNA STAT TEST KIT
K843904 · Whittaker Bioproducts, Inc. · Nov 1984
AMIZYME-ANA TEST KIT
K842532 · Amico Lab, Inc. · Sep 1984