510(k) Report

FDA product code · Microbiology

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

QMIClass II21 CFR 866.3183510(k) required2 decisions since 20200 recalls

2 FDA decisions since 2020. 510(k) reviews decided 2021–2025 took a median of 266 days (half between 266 and 266). No recall names this code. The most-cited predicate is K202215, named by 1 later device.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of QMI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QMI

1in 2025

2020: 12025: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QMI

Too few QMI 510(k)s in any year since 2007 to give a median.

Recalls per year · QMI

No recall names QMI since 2007.

Adverse event reports per year · QMI

No MAUDE report names QMI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—00
20220—00
20230—00
20240—00
20251—00
20260—0—
FIG. 1 — QMI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QMI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do QMI devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. · 20201cites it

Which QMI devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K241921Alinity m BKVAbbott Molecular, Inc. · 20253generations
  • K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. · 20201generation

What has FDA decided in QMI lately?

  • K241921Alinity m BKVAbbott Molecular, Inc. · 2025
  • K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. · 2020

All 2 QMI decisions →

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