Cleared Traditional

K911430 - IDEIA(TM) CHLAMYDIA, MODIFICATION

K911430 is an FDA 510(k) clearance for IDEIA(TM) CHLAMYDIA, manufactured by Novo Nordisk Diagnostics, Ltd.. The device is a Class 2 Microbiology device with product code LIC cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

FDA 510(k) Submission Details - K911430

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.

LIC Device Classification - Class 2, Special Controls

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.