510(k) Report

510(k) · Cleared

Cleared

Triage,Parasite Panel, Triage Cryptosporidium and Entamoeba Histolytica, Triage Cryptosporidium and Giardia Lamblia

K982245510(k) TraditionalCleared Oct 6, 1998102-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

Biosite Incorporated · MHI Giardia Spp.

Cleared on Oct 6, 1998 after a 102-day review. The FDA summary names its predicate without a number.

Decided
Oct 6, 1998
Review
102 days
Class
Class II
Product code
MHI
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K982245Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Single Test Kits manufactured by Alexon
Named without a submission number
—
*—Single Test Kits manufactured by TechLabs
Named without a submission number
—
*—Single Test Kits manufactured by Meridian Diagnostics
Named without a submission number
—
*—Enzyme immunoassay tests manufactured by Trend
Named without a submission number
—
*—Enzyme immunoassay tests manufactured by LMD laboratories
Named without a submission number
—

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 MHI devices

MHI Giardia Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHI

1in 2013

2009: 12011: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHI

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

Recalls per year · MHI

1in 2025

2008: 12025: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MHI

No MAUDE report names MHI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20091—00
20100—00
20111—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

What is it indicated for?

The Triage® Parasite Panel is an enzyme immunoassay used for the detection of antigens for Entamoeba histolytica/dispar, Cryptosporidium parvum and Giardia lamblia in human fecal specimens. The test will be offered as singular tests for each protein, combinations of two organisms per panel and a panel consisting of all three tests. This test is used as an aid in the diagnosis of intestinal parasitic diseases.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Biosite Incorporated

46 FDA decisions under this applicant name. See the company

  • K092987Inratio/INRATIO2 Test StripsBiosite Incorporated · 20106 Class I recalls
  • K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
  • K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
  • K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 20082 Class I recalls
  • K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 20075 recalls

Recent decisions in MHI

The MHI category page

  • K120001Unigold GiardiaTrinity Biotech · 2013
  • K103673Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center · 2011
  • K081064Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LFIvd Research, Inc. · 2009
  • K031942Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 2003
  • K031834Xpect Giardia/Cryptosporidium Lateral Flow AssayRemel, Inc. · 20031 recall

https://510kreport.com/device/K982245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982245: Triage,Parasite Panel, Triage Cryptosporidium and Entamoeba Histolytica, Triage Cryptosporidium and Giardia Lamblia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982245

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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