Cleared Traditional

K811022 - ANA TEST KIT

K811022 is the FDA 510(k) clearance for ANA TEST KIT by Immuno-Diagnostic Products, Inc.. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K811022 · Immuno-Diagnostic Products, Inc. · Immunology device
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Apr 1981
Decision
8d
Days
Class 2
Risk

K811022 is an FDA 510(k) clearance for the ANA TEST KIT. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Immuno-Diagnostic Products, Inc.. The FDA issued a Cleared decision on April 23, 1981 after a review of 8 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 Immuno-Diagnostic Products, Inc. devices

Submission Details

510(k) Number K811022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1981
Decision Date April 23, 1981
Days to Decision 8 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 104d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 54
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K811022.
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
K822681 · Amico Lab, Inc. · Dec 1982
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
K822682 · Amico Lab, Inc. · Dec 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592 · Kallestad Laboratories, Inc. · Jan 1982
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · Immuno Concepts, Inc. · Feb 1981
ANA-IFA TEST SYSTEM
K803276 · Immuno Concepts, Inc. · Jan 1981
ANATON
K801046 · Armkel, LLC · May 1980