510(k) Report

510(k) · Cleared

Cleared

Vysis D7S486/Cep 7 Fish Probe Kit

K131508510(k) TraditionalCleared Sep 13, 2013112-day reviewClass II21 CFR 864.1870

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

Abbott Molecular, Inc. · PFG Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders

Cleared on Sep 13, 2013 as substantially equivalent to DEN130010 (Abbott Molecular, Inc., 2013) after a 112-day review. Its family tree reaches back 1 generation to 2013.

Decided
Sep 13, 2013
Review
112 days
Class
Class II
Product code
PFG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN130010 (2013). No later device cites it as a predicate yet.

DEN130010 · Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization) · Abbott Molecular, Inc. · 2013201020122014
DEN130010 · Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization) · Abbott Molecular, Inc. · 20130
  1. Root · 1 generation backDEN130010 Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization)Abbott Molecular, Inc. · 2013
  2. This deviceK131508 Vysis D7S486/Cep 7 Fish Probe KitAbbott Molecular, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN130010Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization)Abbott Molecular, Inc.2013—
0 (this device)K131508Vysis D7S486/Cep 7 Fish Probe KitAbbott Molecular, Inc.2013—
FIG. 1 — Lineage of K131508, 2013–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PFG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN130010Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization)
Our reading of the summary gave K123951, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130010, Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization) (Abbott Molecular, Inc.), granted Jul 29, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
Abbott Molecular, Inc.2013—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All PFG devices

PFG Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PFG

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PFG

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

Recalls per year · PFG

No recall names PFG since 2007.

Adverse event reports per year · PFG

No MAUDE report names PFG 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
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Vysis D7S486/CEP 7 FISH Probe Kit is a device intended for specimen characterization, and detects the LSI D7S486 probe target on chromosome 7q31 and the CEP 7 probe target on chromosome 7p11.1-q11.1 in bone marrow and peripheral blood specimens from patients with acute myeloid leukemia or myelodysplastic syndrome. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. This device is not intended for high-risk uses such as selecting therapy, predicting therapeutic response or disease screening. The use of this device for diagnosis, prognosis, monitoring, or risk assessment has not been established.

Indications for use as stated in the FDA summary.

More from Abbott Molecular, Inc.

206 FDA decisions under this applicant name. See the company

https://510kreport.com/device/K131508 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131508: Vysis D7S486/Cep 7 Fish Probe Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131508

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026