Cleared Traditional

K203035 - Eonis SCID-SMA kit (FDA 510(k) Clearance)

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

K203035 · Perkinelmer, Inc. · Medical Genetics device
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Nov 2022
Decision
765d
Days
Class 2
Risk

K203035 is an FDA 510(k) clearance for the Eonis SCID-SMA kit. Classified as Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System (product code PJI), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on November 9, 2022 after a review of 765 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.5930 - the FDA medical genetics 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 Medical Genetics submissions.

View all Perkinelmer, Inc. devices

Submission Details

510(k) Number K203035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2020
Decision Date November 09, 2022
Days to Decision 765 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
366d slower than avg
Panel avg: 399d · This submission: 765d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PJI Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5930
Definition A Newborn Screening Test For Severe Combined Immunodeficiency (scid) Intended For The Detection Of T-cell Receptor Excision Circle (trec) Genomic Dna Isolated From Newborn Blood Specimens Dried On Filter Paper. It Is Intended As An Aid In Screening Newborns For Severe Combined Immunodeficiency (scid).
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 Medical Genetics devices follow this clearance model.