Cleared Traditional

K031308 - RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760

K031308 is an FDA 510(k) clearance for RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, manufactured by Rhigene, Inc.. The device is a Class 2 Immunology device with product code DBM cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K031308 · Rhigene, Inc. · Immunology device
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Sep 2003
Decision
155d
Days
Class 2
Risk

K031308 is an FDA 510(k) clearance for the RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Rhigene, Inc. (Westminster, US). The FDA issued a Cleared decision on September 26, 2003 after a review of 155 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - 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 Rhigene, Inc. devices

FDA 510(k) Submission Details - K031308

510(k) Number K031308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date September 26, 2003
Days to Decision 155 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 105d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBM Device Classification - Class 2, Special Controls

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
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 - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 19
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K031308.
ELIA M2
K141375 · Phadia US, Inc. · Feb 2015
EUROIMMUN ANTI-M2-3E ELISA (IGG)
K092736 · Euroimmun Us, Inc. · Sep 2010
QUANTA LITE M2 EP (MIT3) ELISA
K052262 · Inova Diagnostics, Inc. · Oct 2005
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238 · The Binding Site, Ltd. · Mar 2003
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · Trace Scientific , Ltd. · Sep 1998
VIRGO AMA ELISA KIT
K971909 · Hemagen Diagnostics, Inc. · Jun 1997