Cleared Traditional

K024031 - THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE

K024031 is an FDA 510(k) clearance for THE THERATEST EL-ANA PROFILES: ANTI-CEN..., manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K024031 · Theratest Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
62d
Days
Class 2
Risk

K024031 is an FDA 510(k) clearance for the THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on February 6, 2003 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Theratest Laboratories, Inc. devices

FDA 510(k) Submission Details - K024031

510(k) Number K024031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2002
Decision Date February 06, 2003
Days to Decision 62 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
43d faster than avg
Panel avg: 105d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 77
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K024031.
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188 · Phadia US, Inc. · Mar 2009
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102 · Immco Diagnostics, Inc. · Oct 2004
EL-ANA PROFILES: ANTI-CHROMATIN
K040291 · Theratest Laboratories, Inc. · Mar 2004
ANA EIA DIAGNOSTIC TEST KIT
K004019 · The Binding Site, Ltd. · Feb 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959 · Inova Diagnostics, Inc. · Jan 2001
EL-ANA PROFILES-2K1
K002559 · Theratest Laboratories, Inc. · Sep 2000