510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Premier-Cryptococcal Antigen

K904393510(k) TraditionalCleared Jan 25, 1991122-day reviewClass II21 CFR 866.3165Recalls 1

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

Meridian Diagnostics, Inc. · MDU Antigen, Elisa, Cryptococcus

Cleared on Jan 25, 1991 after a 122-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Jan 25, 1991
Review
122 days
Class
Class II
Product code
MDU
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared1990200020102020
  1. This deviceK904393 Premier-Cryptococcal AntigenMeridian Diagnostics, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK120946 Alpha Cryptococcal Antigen EiaImmuno-Mycologics, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K120946Alpha Cryptococcal Antigen EiaImmuno-Mycologics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904393Premier-Cryptococcal AntigenMeridian Diagnostics, Inc.1991—
+1K120946Alpha Cryptococcal Antigen EiaImmuno-Mycologics, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K904393, 1991–2012Source: 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), 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120946Alpha Cryptococcal Antigen EiaImmuno-Mycologics, Inc.20120

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 17, 2018Class IIZ-0732-2019Unknown/Undetermined by firmAn enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K120946 (Immuno-Mycologics, Inc., 2012) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MDU devices

MDU Antigen, Elisa, Cryptococcus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDU

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDU

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

Recalls per year · MDU

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

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

Adverse event reports per year · MDU

No MAUDE report names MDU 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
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—10
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Meridian Diagnostics, Inc.

92 FDA decisions under this applicant name. See the company

  • K993914Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 19992 recalls
  • K990263Immunocard Stat! E. Coli O157:H7Meridian Diagnostics, Inc. · 1999
  • K984343Premier Type Specific HSV-1 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K984346Premier Type Specific HSV-2 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K983255Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 19981 recall

Recent decisions in MDU

The MDU category page

  • K120946Alpha Cryptococcal Antigen EiaImmuno-Mycologics, Inc. · 2012

https://510kreport.com/device/K904393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K904393: Premier-Cryptococcal Antigen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904393

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