Cleared Traditional

K792184 - LAB-TEK ANA TEST KIT

K792184 is the FDA 510(k) clearance for LAB-TEK ANA TEST KIT by Miles Laboratories, Inc.. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K792184 · Miles Laboratories, Inc. · Immunology device
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Nov 1979
Decision
32d
Days
Class 2
Risk

K792184 is an FDA 510(k) clearance for the LAB-TEK ANA TEST KIT. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1979 after a review of 32 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K792184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1979
Decision Date November 30, 1979
Days to Decision 32 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
72d faster than avg
Panel avg: 104d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 51
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K792184.
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · Immuno Concepts, Inc. · Feb 1981
ANA-IFA TEST SYSTEM
K803276 · Immuno Concepts, Inc. · Jan 1981
ANATON
K801046 · Armkel, LLC · May 1980
AUTOANTIBODY REAGENTS, AFT SYSTEM II
K790280 · Calbiochem-Behring Corp. · Apr 1979
TEST KIT, IIF-ANA
K782048 · Medica Corp. · Jan 1979
FLUORESCENT ANTI-NATIVE DNA TEST
K780899 · Kallestad Laboratories, Inc. · Sep 1978