Cleared Traditional

K861978 - AUTOFLUOR V

K861978 is an FDA 510(k) clearance for AUTOFLUOR V, manufactured by Technia Diagnostics , Ltd.. The device is a Class 2 Immunology device with product code KTL cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K861978 · Technia Diagnostics , Ltd. · Immunology device
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Jun 1986
Decision
20d
Days
Class 2
Risk

K861978 is an FDA 510(k) clearance for the AUTOFLUOR V. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Technia Diagnostics , Ltd. (Elwood, US). The FDA issued a Cleared decision on June 10, 1986 after a review of 20 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 Technia Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K861978

510(k) Number K861978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1986
Decision Date June 10, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 105d · This submission: 20d
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 K861978.
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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