Cleared Traditional

K192947 - AncestryDNA Saliva Collection Kit

K192947 is an FDA 510(k) clearance for AncestryDNA Saliva Collection Kit, manufactured by Ancestry Genomics, Inc.. The device is a Class 2 Chemistry device with product code OYJ cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K192947 · Ancestry Genomics, Inc. · Chemistry device
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Aug 2020
Decision
300d
Days
Class 2
Risk

K192947 is an FDA 510(k) clearance for the AncestryDNA Saliva Collection Kit. Classified as Dna Specimen Collection, Saliva (product code OYJ), Class II - Special Controls.

Submitted by Ancestry Genomics, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 13, 2020 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ancestry Genomics, Inc. devices

FDA 510(k) Submission Details - K192947

510(k) Number K192947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2019
Decision Date August 13, 2020
Days to Decision 300 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
212d slower than avg
Panel avg: 88d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OYJ Device Classification - Class 2, Special Controls

Product Code OYJ Dna Specimen Collection, Saliva
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition A Collection Device Intended For Use In The Non-invasive Collection Of Saliva Samples For Clinical Dna 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.

Regulatory Peers - OYJ Dna Specimen Collection, Saliva

Devices cleared under the same product code (OYJ) and FDA review panel - the closest regulatory comparables to K192947.
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