Cleared Traditional

K943585 - ANTI-HISTONE ANIBODY TEST

K943585 is an FDA 510(k) clearance for ANTI-HISTONE ANIBODY TEST, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K943585 · Immco Diagnostics, Inc. · Immunology device
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Jan 1995
Decision
182d
Days
Class 2
Risk

K943585 is an FDA 510(k) clearance for the ANTI-HISTONE ANIBODY TEST. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K943585

510(k) Number K943585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date January 20, 1995
Days to Decision 182 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 104d · This submission: 182d
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 63
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K943585.
VARELISA ANA-4 SCREEN
K951186 · Elias U.S.A., Inc. · Apr 1995
VARELISA ANA PROFILE
K951205 · Elias U.S.A., Inc. · Apr 1995
VARELISA HISTONE ANTIBODIES
K951207 · Elias U.S.A., Inc. · Apr 1995
VARELISA RNP-SM ANTIBODIES
K944167 · Elias U.S.A., Inc. · Dec 1994
VARELISA LA (SS-B) ANTIBODIES
K944168 · Elias U.S.A., Inc. · Dec 1994
VARELISA RO (SS-A) ANTIBODIES
K944169 · Elias U.S.A., Inc. · Dec 1994