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510(k) K100015

VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 by Abbott Molecular, Inc. — Product Code OVQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2011
Date Received
January 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chronic Lymphocytic Leukemia Fish Probe Kit
Device Class
Class II
Regulation Number
866.6040
Review Panel
PA
Submission Type

The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information.

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  • K241921 — Alinity m BKV (March 24, 2025)
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  • 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)

Other clearances for product code OVQ

  • K962873 — CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE (January 13, 1997)