510(k) · Cleared

Cleared

Uni-Gold Cryptosporidium

K121565510(k) TraditionalCleared Feb 8, 2013255-day reviewClass II21 CFR 866.3220

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

Trinity Biotech · MHJ Cryptosporidium Spp.

Cleared on Feb 8, 2013 as substantially equivalent to K031965 (Remel, Inc., 2003) after a 255-day review. Its family tree reaches back 2 generations to 1999.

Decided: Feb 8, 2013
Review: 255 days
Class: Class II
Product code: MHJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K983399 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK983399 Giardia/Cryptosporidium Combo Rapid AssayGenzyme Diagnostics · 1999 · Recalled
1 generation backK031965 Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. · 2003 · Recalled
This deviceK121565 Uni-Gold CryptosporidiumTrinity Biotech · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K983399	Giardia/Cryptosporidium Combo Rapid Assay	Genzyme Diagnostics	1999	2
−1	K031965	Xpect Cryptosporidium Lateral Flow Assay, Model 2451020	Remel, Inc.	2003	1
0 (this device)	K121565	Uni-Gold Cryptosporidium	Trinity Biotech	2013	—

FIG. 1 — Lineage of K121565, 1999–2013Source: 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 MHJ? 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
*	K031965	Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 Summary page 2 …Page: 2 of 8 YOUR PARTNER DIAGNOSTICS Predicate Remel Xpect Cryptosporidium (51OK #: K031 965) Device Device Description The Trinity Biotech Uni-God T MI Cryptosporidium Test was designed as a single…	Remel, Inc.	2003	1

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 14 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
2 of the 2 ancestors have a recall of any class.

How does its category compare?

All MHJ devices

MHJ Cryptosporidium Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · MHJ

1in 2017

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHJ

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

Recalls per year · MHJ

No recall names MHJ since 2007.

Adverse event reports per year · MHJ

No MAUDE report names MHJ 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	0	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	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?

Trinity Biotech Uni-GoldTM Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121565 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121565: Uni-Gold Cryptosporidium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121565

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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