Cleared Traditional

K822682 - ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K

K822682 is the FDA 510(k) clearance for ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K by Amico Lab, Inc.. It is a Class 2 Microbiology device (product code DHN) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K822682 · Amico Lab, Inc. · Microbiology device
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Dec 1982
Decision
91d
Days
Class 2
Risk

K822682 is an FDA 510(k) clearance for the ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Amico Lab, Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5100 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amico Lab, Inc. devices

Submission Details

510(k) Number K822682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1982
Decision Date December 03, 1982
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 Microbiology devices follow this clearance model.

Regulatory Peers - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 53
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K822682.
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127 · Electro-Nucleonics Laboratories, Inc. · Apr 1984
AFT SYSTEM III
K830214 · Calbiochem-Behring Corp. · Mar 1983
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
K822681 · Amico Lab, Inc. · Dec 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592 · Kallestad Laboratories, Inc. · Jan 1982
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · Immuno Concepts, Inc. · Feb 1981
ANA-IFA TEST SYSTEM
K803276 · Immuno Concepts, Inc. · Jan 1981