510(k) Report

510(k) · Cleared

Recalled · 2003

Prospect Giardia/Cryptosporidium Microplate Assay

K955157510(k) TraditionalCleared Feb 9, 199688-day reviewClass II21 CFR 866.3220Recalls 2

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

Alexon Biomedical, Inc. · MHI Giardia Spp.

Cleared on Feb 9, 1996 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.

Decided
Feb 9, 1996
Review
88 days
Class
Class II
Product code
MHI
Recalls
2
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2017: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955157 Prospect Giardia/Cryptosporidium Microplate AssayAlexon Biomedical, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK051929 Giardia/Cryptosporidium ChekTechlab, Inc. · 2005
  3. Descendant · 2 generations on · 0 of its ownK171078 Tri-Combo Parasite ScreenTechlab, Inc. · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K051929Giardia/Cryptosporidium ChekTechlab, Inc. · 2005 · cites it directly1descendant
  • K171078Tri-Combo Parasite ScreenTechlab, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955157Prospect Giardia/Cryptosporidium Microplate AssayAlexon Biomedical, Inc.1996—
+1K051929Giardia/Cryptosporidium ChekTechlab, Inc.2005—
+2K171078Tri-Combo Parasite ScreenTechlab, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201710
FIG. 1 — Lineage of K955157, 1996–2017Source: 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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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K051929Giardia/Cryptosporidium ChekTechlab, Inc.20051

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 9, 2003Not classifiedZ-1375-04OtherThe conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
Nov 21, 2002Not classifiedZ-1374-04OtherThe conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051929 (Techlab, Inc., 2005) has gone furthest, with 1 descendant of its own.

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—

More from Alexon Biomedical, Inc.

5 FDA decisions under this applicant name. See the company

  • K964864Prospect II Clostridium Diffillie Toxin a Microplate AssayAlexon Biomedical, Inc. · 1997
  • K936191Prospect Cryptosporidium Rapid AssayAlexon Biomedical, Inc. · 1994
  • K933997Prospect Entamoeba Histolytica Microplate AssayAlexon Biomedical, Inc. · 1993
  • K874849Prospect/GiardiaAlexon Biomedical, Inc. · 1988

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/K955157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955157: Prospect Giardia/Cryptosporidium Microplate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955157

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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