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
QDCClass II

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

21 CFR 866.6100 / Pathology
FDA source (opens on fda.gov)

QDC is the FDA product code for Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies, a class II device type, regulated under 21 CFR 866.6100. FDA's definition for this code reads: "A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QDC
Device name
Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
FDA definition
A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual disease to monitor the change in burden of disease for patients with a hematological malignancy during and after treatment. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
Regulation
21 CFR 866.6100
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
2
Ingested recalls
0

Clearances, product code QDC

By decision year
2 clearances under product code QDC with a decision year between 2018 and 2020, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDC by decision year
YearClearances
20181
20201

Applicants with the most clearances

Product code QDC
Applicants holding the most 510(k) clearances under product code QDC
ApplicantClearances
Adaptive Biotechnologies2

Companies listing this code with FDA

Companies whose registered establishments list this code