Cleared Traditional

K840221 - EXTRACTABLE NUCLEAR ANTIGEN ASSAY

K840221 is an FDA 510(k) clearance for EXTRACTABLE NUCLEAR ANTIGEN ASSAY, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LLL cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K840221 · Zeus Scientific, Inc. · Microbiology device
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May 1984
Decision
124d
Days
Class 2
Risk

K840221 is an FDA 510(k) clearance for the EXTRACTABLE NUCLEAR ANTIGEN ASSAY. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 124 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K840221

510(k) Number K840221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date May 22, 1984
Days to Decision 124 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
22d slower than avg
Panel avg: 102d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 127
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K840221.
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
K860644 · Immuno Concepts, Inc. · Mar 1986
PHYSIO GAS ANALYZER
K843423 · Research Medical, Inc. · Feb 1985
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978 · Behring Diagnostics, Inc. · Dec 1984
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036 · Calbiochem-Behring Corp. · Apr 1983