Cleared Traditional

K011244 - ZEUS SCIENTIFIC

K011244 is an FDA 510(k) clearance for ZEUS SCIENTIFIC, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K011244 · Zeus Scientific, Inc. · Immunology device
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Dec 2001
Decision
231d
Days
Class 2
Risk

K011244 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 10, 2001 after a review of 231 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 - K011244

510(k) Number K011244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date December 10, 2001
Days to Decision 231 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
127d slower than avg
Panel avg: 104d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 30
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K011244.
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
K024226 · Bio-Rad · Jan 2003
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · Diagnostic Products Corp. · Jun 2002
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K021103 · Zeus Scientific, Inc. · Apr 2002
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
K993294 · Diamedix Corp. · Oct 1999
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
K984464 · Bio-Rad · Dec 1998
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
K984470 · Bio-Rad · Dec 1998