510(k) Report

510(k) · Cleared

Recalled · 2008

Xpect Giardia/Cryptosporidium Lateral Flow Assay

K031834510(k) TraditionalCleared Nov 10, 2003150-day reviewClass II21 CFR 866.3220Recalls 1

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

Remel, Inc. · MHI Giardia Spp.

Cleared on Nov 10, 2003 as substantially equivalent to K983399 (Genzyme Diagnostics, 1999) after a 150-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.

Decided
Nov 10, 2003
Review
150 days
Class
Class II
Product code
MHI
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K983399 (1999). No later device cites it as a predicate yet.

K983399 · Giardia/Cryptosporidium Combo Rapid Assay · Genzyme Diagnostics · 1999 · recalled19961998200020022004
K983399 · Giardia/Cryptosporidium Combo Rapid Assay · Genzyme Diagnostics · 1999 · recalled0
  1. Root · 1 generation backK983399 Giardia/Cryptosporidium Combo Rapid AssayGenzyme Diagnostics · 1999 · Recalled
  2. This deviceK031834 Xpect Giardia/Cryptosporidium Lateral Flow AssayRemel, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983399Giardia/Cryptosporidium Combo Rapid AssayGenzyme Diagnostics19992
0 (this device)K031834Xpect Giardia/Cryptosporidium Lateral Flow AssayRemel, Inc.2003—
FIG. 1 — Lineage of K031834, 1999–2003Source: 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), 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 MHI? 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.

TypeNumberDeviceApplicantDecidedRecalls
*K983399Giardia/Cryptosporidium Combo Rapid AssayGenzyme Diagnostics19992

Also cleared against K983399: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 11, 2008Not classifiedZ-2432-2008Process controlFaint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 2 other devices also cite its predicate K983399.

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?

REMEL’s XpectTMGiardia/Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.

Indications for use as stated in the FDA summary.

Also cleared against K983399

2 other devices cite the same predicate.

  • K031942Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 2003
  • K031965Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. · 20031 recall

More from Remel, Inc.

17 FDA decisions under this applicant name. See the company

  • K162620Remel Spectra ESBLRemel, Inc. · 2017
  • K131804Remel Xpect Flu a&BRemel, Inc. · 2013
  • K092407Remel Spectra MrsaRemel, Inc. · 20101 recall
  • K072827Rpmi 1640 Agar W/Mops and 2% GlucoseRemel, Inc. · 2007
  • K041951Xpect Clostridium Difficile Toxin a/BRemel, Inc. · 2004

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
  • K033274Giardia IITechlab, Inc. · 2003

https://510kreport.com/device/K031834 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031834: Xpect Giardia/Cryptosporidium Lateral Flow Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031834

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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