Cleared Traditional

K842707 - ADP NDNA IFA TEST

K842707 is an FDA 510(k) clearance for ADP NDNA IFA TEST, manufactured by Apple Diagnostic Products. The device is a Class 2 Immunology device with product code KTL cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K842707 · Apple Diagnostic Products · Immunology device
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Aug 1984
Decision
40d
Days
Class 2
Risk

K842707 is an FDA 510(k) clearance for the ADP NDNA IFA TEST. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Apple Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on August 21, 1984 after a review of 40 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 - K842707

510(k) Number K842707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1984
Decision Date August 21, 1984
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 105d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTL Device Classification - Class 2, Special Controls

Product Code KTL Anti-dna Indirect Immunofluorescent Solid Phase
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 - KTL Anti-dna Indirect Immunofluorescent Solid Phase

All 13
Devices cleared under the same product code (KTL) and FDA review panel - the closest regulatory comparables to K842707.
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
K990916 · Stellar Bio Systems, Inc. · Apr 1999
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
K930987 · The Binding Site, Ltd. · Aug 1993
DISTAT ANTI-DSDNA KIT
K905386 · Shield Diagnostics, Ltd. · Dec 1990
ANTI-NATIVE DNA ANTIBODY
K834349 · Sigma Chemical Co. · Apr 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
K834140 · Intl. Diagnostic Technology · Jan 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
K833984 · Intl. Diagnostic Technology · Jan 1984