Cleared Traditional

K842183 - ADP ANA IFA TEST

K842183 is an FDA 510(k) clearance for ADP ANA IFA TEST, manufactured by Apple Diagnostic Products. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K842183 · Apple Diagnostic Products · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
21d
Days
Class 2
Risk

K842183 is an FDA 510(k) clearance for the ADP ANA IFA TEST. 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 June 22, 1984 after a review of 21 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 Apple Diagnostic Products devices

FDA 510(k) Submission Details - K842183

510(k) Number K842183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1984
Decision Date June 22, 1984
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 105d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K842183.
COLORZYME NDNA TEST SYSTEM
K843225 · Immuno Concepts, Inc. · Nov 1984
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
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119 · Atlantic Antibodies · Nov 1983
IDT ANA STIQ ASSAY
K832383 · Intl. Diagnostic Technology · Aug 1983