510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SBYClass II

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

21 CFR 866.6085 / Pathology
FDA source (opens on fda.gov)

SBY is the FDA product code for High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids, a class II device type, regulated under 21 CFR 866.6085. FDA's definition for this code reads: "A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SBY
Device name
High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
FDA definition
A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.
Regulation
21 CFR 866.6085
Device class
Class II
Review panel
Pathology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SBY

By decision year
1 clearance under product code SBY with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SBY by decision year
YearClearances
20241

Applicants with the most clearances

Product code SBY
Applicants holding the most 510(k) clearances under product code SBY
ApplicantClearances
Personal Genome Diagnostics Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code