Cleared Traditional

K811714 - HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT

K811714 is an FDA 510(k) clearance for HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT, manufactured by Scripps-Miles, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K811714 · Scripps-Miles, Inc. · Immunology device
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Jul 1981
Decision
23d
Days
Class 2
Risk

K811714 is an FDA 510(k) clearance for the HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Scripps-Miles, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 23 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 - K811714

510(k) Number K811714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1981
Decision Date July 10, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 105d · This submission: 23d
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 98
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K811714.
ANA TEST (MOUSE LIVER SUBSTRATE)
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QUANTAFLUOR FLUORESCENT TEST REAGENTS
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CRITHIDNA ANTI-DNA TEST KIT
K812314 · Antibodies, Inc. · Sep 1981
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT
K810985 · Immuno-Products Industries · May 1981
ANA TEST KIT
K811022 · Immuno-Diagnostic Products, Inc. · Apr 1981
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · Immuno Concepts, Inc. · Feb 1981
K811714 · HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
Download PDF Scripps-Miles, Inc.