Cleared Traditional

IDEIA(TM) CHLAMYDIA, MODIFICATION (K911430) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911430 · Novo Nordisk Diagnostics, Ltd. · Microbiology device
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Aug 1991
Decision
132d
Days
Class 2
Risk

K911430 is an FDA 510(k) clearance for the IDEIA(TM) CHLAMYDIA, MODIFICATION. Classified as Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae (product code LIC), Class II - Special Controls.

Submitted by Novo Nordisk Diagnostics, Ltd. (Cambridge Cb4 4ws England, GB). The FDA issued a Cleared decision on August 7, 1991 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Novo Nordisk Diagnostics, Ltd. devices

Submission Details

510(k) Number K911430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date August 07, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 102d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIC Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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 Microbiology devices follow this clearance model.