Cleared Traditional

K832383 - IDT ANA STIQ ASSAY

K832383 is an FDA 510(k) clearance for IDT ANA STIQ ASSAY, manufactured by Intl. Diagnostic Technology. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K832383 · Intl. Diagnostic Technology · Immunology device
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Aug 1983
Decision
43d
Days
Class 2
Risk

K832383 is an FDA 510(k) clearance for the IDT ANA STIQ ASSAY. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 43 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.

FDA 510(k) Submission Details - K832383

510(k) Number K832383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1983
Decision Date August 31, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 105d · This submission: 43d
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 109
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K832383.
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127 · Electro-Nucleonics Laboratories, Inc. · Apr 1984
ANA APPLELISA
K834241 · Apple Diagnostic Products · Apr 1984
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119 · Atlantic Antibodies · Nov 1983
DNA FLOR
K831408 · Medastat Scientific Corp. · Jul 1983
ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
K831054 · Immuno-Products Industries · Apr 1983
AFT SYSTEM III
K830214 · Calbiochem-Behring Corp. · Mar 1983
K832383 · IDT ANA STIQ ASSAY
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