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510(k) K241921

Alinity m BKV by Abbott Molecular, Inc. — Product Code QMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2025
Date Received
July 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Device Class
Class II
Regulation Number
866.3183
Review Panel
MI
Submission Type

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.

Other clearances by Abbott Molecular, Inc.

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  • K243489 — Alinity m EBV (09N43-095) (July 28, 2025)
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  • K241573 — Alinity m Resp-4-Plex (February 14, 2025)
  • K243410 — simpli-COLLECT STI Test (January 30, 2025)
  • K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-0 (December 6, 2024)
  • K233349 — Alinity m HSV 1 & 2 / VZV (May 3, 2024)
  • K222379 — Alinity m STI Assay (March 3, 2023)
  • K212778 — Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N (July 15, 2022)
  • K202977 — Alinity m STI Assay (April 29, 2022)

Other clearances for product code QMI

  • K202215 — cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (September 2, 2020)