Cleared Traditional

K834241 - ANA APPLELISA

K834241 is the FDA 510(k) clearance for ANA APPLELISA by Apple Diagnostic Products. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K834241 · Apple Diagnostic Products · Immunology device
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Apr 1984
Decision
120d
Days
Class 2
Risk

K834241 is an FDA 510(k) clearance for the ANA APPLELISA. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Apple Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 120 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K834241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1983
Decision Date April 04, 1984
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 104d · This submission: 120d
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 56
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K834241.
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · Behring Diagnostics, Inc. · Jun 1984
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127 · Electro-Nucleonics Laboratories, Inc. · Apr 1984
AFT SYSTEM III
K830214 · Calbiochem-Behring Corp. · Mar 1983
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