Not Cleared Direct

DEN160025 - ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160025 · Id-Fish Technology, Inc. · Microbiology device
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Aug 2017
Decision
417d
Days
Class 2
Risk

DEN160025 is an FDA 510(k) submission (not cleared) for the ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax.... Classified as Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. (product code PYN), Class II - Special Controls.

Submitted by Id-Fish Technology, Inc. (Palo Alto, US). The FDA issued a Not Cleared (DENG) decision on August 18, 2017 after a review of 417 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3367 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 417 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN160025 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 27, 2016
Decision Date August 18, 2017
Days to Decision 417 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
315d slower than avg
Panel avg: 102d · This submission: 417d
Pathway characteristics

Device Classification

Product Code PYN Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3367
Definition The Plasmodium Sp. Fish Is Intended To Detect Plasmodium Spp. Parasites And/or Differentiate Parasite Species In Clinical Whole Blood Smear Specimens From Patients With Signs Or Symptoms Of Malaria And Suspicion Of Infection.
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.