K100015 is an FDA 510(k) clearance for the VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34. This device is classified as a Chronic Lymphocytic Leukemia Fish Probe Kit (Class II - Special Controls, product code OVQ).
Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on August 9, 2011, 582 days after receiving the submission on January 4, 2010.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6040. 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..
| 510(k) Number | K100015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2010 |
| Decision Date | August 09, 2011 |
| Days to Decision | 582 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | OVQ - Chronic Lymphocytic Leukemia Fish Probe Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6040 |
| Definition | 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. |