Cleared Dual Track

K221925 - ID NOW COVID-19 2.0 (FDA 510(k) Clearance)

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

K221925 · Abbott Diagnostics Scarborough, Inc. · Microbiology device
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Aug 2023
Decision
405d
Days
Class 2
Risk

K221925 is an FDA 510(k) clearance for the ID NOW COVID-19 2.0. Classified as Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings (product code QWR), Class II - Special Controls.

Submitted by Abbott Diagnostics Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on August 10, 2023 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3982 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Abbott Diagnostics Scarborough, Inc. devices

Submission Details

510(k) Number K221925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date August 10, 2023
Days to Decision 405 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
303d slower than avg
Panel avg: 102d · This submission: 405d
Pathway characteristics

Device Classification

Product Code QWR Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3982
Definition A Simple Point-of-care Device To Detect Sars-cov-2 Nucleic Acid Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections (covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory.
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.