Cleared Traditional

K262893 - Eonis™ SMA kit

K262893 is an FDA 510(k) clearance for Eonis SMA kit, manufactured by Revvity, Inc.. The device is a Class 2 Chemistry device with product code QUE cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K262893 · Revvity, Inc. · Chemistry device
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Sep 2026
Decision
44d
Days
Class 2
Risk

K262893 is an FDA 510(k) clearance for the Eonis™ SMA kit. Classified as Spinal Muscular Atrophy Newborn Screening Test System (product code QUE), Class II - Special Controls.

Submitted by Revvity, Inc. (Waltham, US). The FDA issued a Cleared decision on September 30, 2026 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5980 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Revvity, Inc. devices

FDA 510(k) Submission Details - K262893

510(k) Number K262893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2026
Decision Date September 30, 2026
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QUE Device Classification - Class 2, Special Controls

Product Code QUE Spinal Muscular Atrophy Newborn Screening Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5980
Definition A Spinal Muscular Atrophy (sma) Newborn Screening Test System Is A Prescription Device Intended To Detect Homozygous Deletion Of Exon 7 Or Other Similar Mutations In The Smn1 (survival Motor Neuron 1) Gene Of Dna Obtained From Dried Blood Spot Specimens On Filter Paper Using A Polymerase Chain Reaction-based Test As An Aid In Screening Newborns For Sma. Presumptive Positive Results Are Intended To Be Followed Up By Diagnostic Confirmatory Testing.
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 Chemistry devices follow this clearance model.