Cleared Traditional

K940362 - ANA SCREEN ELISA TEST SYSTEM

K940362 is an FDA 510(k) clearance for ANA SCREEN ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K940362 · Zeus Scientific, Inc. · Immunology device
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Jul 1994
Decision
183d
Days
Class 2
Risk

K940362 is an FDA 510(k) clearance for the ANA SCREEN ELISA TEST SYSTEM. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K940362

510(k) Number K940362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date July 28, 1994
Days to Decision 183 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 104d · This submission: 183d
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 Immunology 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 K940362.
ANTI DS-DNA
K943291 · Sigma Diagnostics, Inc. · Dec 1994
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505 · Shield Diagnostics, Ltd. · Nov 1994
QUANTA LITE ENA 5 ELISA KIT
K943076 · Inova Diagnostics, Inc. · Oct 1994
SYN ENA SCREEN (PIN PLATE)
K940229 · Elias U.S.A., Inc. · May 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · Elias U.S.A., Inc. · May 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K935828 · Hemagen Diagnostics, Inc. · Apr 1994