510(k) · Cleared

Cleared

Alpha Histoplasma Antigen Eia Model HAG102

K101407510(k) TraditionalCleared Jul 19, 2011426-day reviewClass II21 CFR 866.3320

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

Immuno-Mycologics, Inc. · MIZ Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Cleared on Jul 19, 2011 as substantially equivalent to K060641 (Bio-Rad, 2006) after a 426-day review. Its family tree reaches back 2 generations to 2003.

Decided: Jul 19, 2011
Review: 426 days
Class: Class II
Product code: MIZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K023857 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK023857 Platelia Aspergillus Eia, Models 62793 and 62794Bio-Rad · 2003 · Recalled
1 generation backK060641 Platelia Aspergillus Eia, Model 62793Bio-Rad · 2006
This deviceK101407 Alpha Histoplasma Antigen Eia Model HAG102Immuno-Mycologics, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K023857	Platelia Aspergillus Eia, Models 62793 and 62794	Bio-Rad	2003	1
−1	K060641	Platelia Aspergillus Eia, Model 62793	Bio-Rad	2006	—
0 (this device)	K101407	Alpha Histoplasma Antigen Eia Model HAG102	Immuno-Mycologics, Inc.	2011	—

FIG. 1 — Lineage of K101407, 2003–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MIZ? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K060641	Platelia Aspergillus Eia, Model 62793 Summary page 1 …Name: Histoplasma Antigen EIA Classification Name: None Regulation: 866.3320 Predicate Device: Blo-Rad's Platelia Tm Aspergillus EIA, K060641 Intended Use: The ALPHA Histaplasmo Antigen EIA is an immunoenzymatic sandwich microplate as…	Bio-Rad	2006	—

Also cleared against K060641: 1 other device →

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?

The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K060641.

How does its category compare?

All MIZ devices

MIZ Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MIZ

1in 2011

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MIZ

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

Recalls per year · MIZ

No recall names MIZ since 2007.

Adverse event reports per year · MIZ

No MAUDE report names MIZ since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The ALPHA Histoplasma Antigen EIA is an immunoenzymatic sandwich microplate assay for the detection of Histoplosma antigens in urine samples.

The ALPHA Histaplasma Antigen EIA is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of histoplasmosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101407 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101407: Alpha Histoplasma Antigen Eia Model HAG102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101407

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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