Cleared Traditional

K040200 - MESACUP-2 TEST CENP-B

K040200 is an FDA 510(k) clearance for MESACUP-2 TEST CENP-B, manufactured by Rhigene, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K040200 · Rhigene, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
35d
Days
Class 2
Risk

K040200 is an FDA 510(k) clearance for the MESACUP-2 TEST CENP-B. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on March 4, 2004 after a review of 35 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.

FDA 510(k) Submission Details - K040200

510(k) Number K040200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2004
Decision Date March 04, 2004
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 105d · This submission: 35d
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 107
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K040200.
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ANA DETECT
K030929 · Orgentec Diagnostika GmbH · May 2003
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
K024031 · Theratest Laboratories, Inc. · Feb 2003
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
K022018 · Rhigene, Inc. · Jul 2002
K040200 · MESACUP-2 TEST CENP-B
Download PDF FDA Summary Rhigene, Inc.