510(k) Report

510(k) · Cleared

Cleared

Yeastest

K993554510(k) TraditionalCleared Feb 10, 2000113-day reviewClass I21 CFR 866.2660

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

Diagnostic Markers, Inc. · JXB Kit, Identification, Yeast

Cleared on Feb 10, 2000 after a 113-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Feb 10, 2000
Review
113 days
Class
Class I
Product code
JXB
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K993554Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JXB? 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 JXB devices

JXB Kit, Identification, Yeast: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JXB

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXB

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

Recalls per year · JXB

2in 2022

2009: 12013: 12021: 12022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXB

6in 2025

2015: 112016: 162017: 182018: 272019: 192020: 122021: 372022: 102023: 102024: 22025: 6
2007high 37 (2021) · low 0 (2007)2025

MAUDE reports naming product code JXB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—10
20100—00
20110—00
20120—00
20130—10
20140—00
20150—011
20160—016
20170—018
20180—027
20190—019
20200—012
20210—137
20220—210
20230—010
20240—02
20250—06
20260—0—

What is it indicated for?

Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Recent decisions in JXB

The JXB category page

  • K080719Yeast Traffic Light Pna FishAdvandx, Inc. · 2008
  • K062461C. Albicans Pna FishAdvandx, Inc. · 2006
  • K943621Rapid Yeast Plus SystemInnovative Diagnostic Systems, Inc. · 19952 recalls
  • K935124Bacticard CandidaRemel Co. · 1994
  • K900112Microring YTMedical Wire & Equipment Co. · 1990

https://510kreport.com/device/K993554 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993554: Yeastest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993554

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