Cleared Traditional

K822681 - ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)

K822681 is an FDA 510(k) clearance for ANTI-NUCLEAR ANTIBODY TEST KIT (ANA), manufactured by Amico Lab, Inc.. The device is a Class 2 Microbiology device with product code DHN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K822681 · Amico Lab, Inc. · Microbiology device
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Dec 1982
Decision
101d
Days
Class 2
Risk

K822681 is an FDA 510(k) clearance for the ANTI-NUCLEAR ANTIBODY TEST KIT (ANA). 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 13, 1982 after a review of 101 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

FDA 510(k) Submission Details - K822681

510(k) Number K822681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1982
Decision Date December 13, 1982
Days to Decision 101 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
1d faster than avg
Panel avg: 102d · This submission: 101d
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 Microbiology devices follow this clearance model.

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

All 71
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K822681.
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119 · Atlantic Antibodies · Nov 1983
IDT ANA STIQ ASSAY
K832383 · Intl. Diagnostic Technology · Aug 1983
AFT SYSTEM III
K830214 · Calbiochem-Behring Corp. · Mar 1983
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
K822682 · Amico Lab, Inc. · Dec 1982
SERA FOR ANTINUCLEAR ANTIBODIES
K820945 · Centers For Disease Control and Prevention · Oct 1982
ANA HEP-2 FLUORO-KIT
K822397 · Clinical Sciences, Inc. · Sep 1982