QQBClass II

Prognostic Test For Assessment Of Liver Related Disease Progression

21 CFR 862.1622 / Clinical Chemistry

QQB is the FDA product code for Prognostic Test For Assessment Of Liver Related Disease Progression, a class II device type, regulated under 21 CFR 862.1622. FDA's definition for this code reads: "prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2021-08-20, and no recalls.

Classification record

Product code: QQB
Device name: Prognostic Test For Assessment Of Liver Related Disease Progression
FDA definition: prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses.
Regulation: 21 CFR 862.1622
Device class: Class II
Review panel: Clinical Chemistry
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 QQB

By decision year

1 clearance under product code QQB with a decision year between 2021 and 2021, 2021 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QQB by decision year
Year	Clearances
2021	1

Applicants with the most clearances

Product code QQB

Applicants holding the most 510(k) clearances under product code QQB
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Siemens Healthcare Diagnostics Inc.

Recent clearances

Product code QQB

DEN190056Class IIADVIA Centaur Enhanced Liver Fibrosis (ELF)Siemens Healthcare Diagnostics, Inc. / cleared 2021-08-20

Recent recalls

Product code QQB

FDA records show no recalls under product code QQB.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)