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QMIClass II

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

21 CFR 866.3183 / Microbiology
FDA source (opens on fda.gov)

QMI is the FDA product code for Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna, a class II device type, regulated under 21 CFR 866.3183. FDA's definition for this code reads: "An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QMI
Device name
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
FDA definition
An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. Test results are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions.
Regulation
21 CFR 866.3183
Device class
Class II
Review panel
Microbiology
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 QMI

By decision year
2 clearances under product code QMI with a decision year between 2020 and 2025, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QMI by decision year
YearClearances
20201
20251

Applicants with the most clearances

Product code QMI
Applicants holding the most 510(k) clearances under product code QMI
ApplicantClearances
Abbott Molecular, Inc.1
Roche Molecular Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code