510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QSAClass II

Circulating Tumor Cell (Ctc) Enrichment Device

21 CFR 866.6110 / Immunology
FDA source (opens on fda.gov)

QSA is the FDA product code for Circulating Tumor Cell (Ctc) Enrichment Device, a class II device type, regulated under 21 CFR 866.6110. FDA's definition for this code reads: "A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QSA
Device name
Circulating Tumor Cell (Ctc) Enrichment Device
FDA definition
A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.
Regulation
21 CFR 866.6110
Device class
Class II
Review panel
Immunology
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 QSA

By decision year
1 clearance under product code QSA with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QSA by decision year
YearClearances
20221

Applicants with the most clearances

Product code QSA
Applicants holding the most 510(k) clearances under product code QSA
ApplicantClearances
Angle Europe, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code