510(k) Report

510(k) · Cleared

Cleared

Rickettsia Real-time PCR Assay

K170940510(k) TraditionalCleared Jun 29, 201791-day reviewClass II21 CFR 866.3316

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

Centers For Disease Control and Prevention (CDC) · PVQ Rickettsia Spp. Nucleic Acid Based Detection Assay

Cleared on Jun 29, 2017 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 29, 2017
Review
91 days
Class
Class II
Product code
PVQ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K170940Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All PVQ devices

PVQ Rickettsia Spp. Nucleic Acid Based Detection Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · PVQ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PVQ

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

Recalls per year · PVQ

No recall names PVQ since 2007.

Adverse event reports per year · PVQ

No MAUDE report names PVQ 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
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Centers For Disease Control and…

6 FDA decisions under this applicant name. See the company

  • K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,Centers For Disease Control and Prevention (CDC) · 2018
  • DEN160016Variola virus Real-Time PCR AssayCenters For Disease Control and Prevention (CDC) · 2017
  • K161556CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping KitCenters For Disease Control and Prevention (CDC) · 2016
  • K153148CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 SubtypingCenters For Disease Control and Prevention (CDC) · 2015
  • K140426Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC) · 2014

https://510kreport.com/device/K170940 · printed Nov 5, 2026

Cite this page

510(k) Report. “K170940: Rickettsia Real-time PCR Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170940

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026