Cleared Traditional

K000336 - RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

K000336 is an FDA 510(k) clearance for RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, manufactured by Rhigene, Inc.. The device is a Class 2 Immunology device with product code NBO cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K000336 · Rhigene, Inc. · Immunology device
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Jun 2000
Decision
127d
Days
Class 2
Risk

K000336 is an FDA 510(k) clearance for the RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E. Classified as Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) (product code NBO), Class II - Special Controls.

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on June 9, 2000 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 - K000336

510(k) Number K000336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2000
Decision Date June 09, 2000
Days to Decision 127 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
22d slower than avg
Panel avg: 105d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBO Device Classification - Class 2, Special Controls

Product Code NBO Autoantibodies, Skin (desmoglein 1 And Desmoglein 3)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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.