Cleared Traditional

K000755 - RHIGENE MESACUP2 TEST- SM

K000755 is an FDA 510(k) clearance for RHIGENE MESACUP2 TEST- SM, manufactured by Rhigene, Inc.. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K000755 · Rhigene, Inc. · Immunology device
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May 2000
Decision
62d
Days
Class 2
Risk

K000755 is an FDA 510(k) clearance for the RHIGENE MESACUP2 TEST- SM. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 9, 2000 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 Rhigene, Inc. devices

FDA 510(k) Submission Details - K000755

510(k) Number K000755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2000
Decision Date May 09, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

LKP Device Classification - Class 2, Special Controls

Product Code LKP Anti-sm 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 - LKP Anti-sm Antibody, Antigen And Control

All 20
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K000755.
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AUTOSTAT II ANTI-SM ELISA
K990625 · Cogent Diagnotics , Ltd. · Apr 1999
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · Bio-Rad · Dec 1998