510(k) · Cleared
ClearedGiardia/ Cryptosporidium Quik Chek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab Inc., Corporate Research Center · MHI Giardia Spp.
Cleared on Aug 18, 2011 as substantially equivalent to K912408 (Meridian Diagnostics, Inc., 1991) and 2 other predicates after a 245-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 18, 2011
- Review
- 245 days
- Class
- Class II
- Product code
- MHI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K912408 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912408 Merifluor-Cryptosporidium/GiardiaMeridian Diagnostics, Inc. · 1991
- This deviceK103673 Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912408 | Merifluor-Cryptosporidium/Giardia | Meridian Diagnostics, Inc. | 1991 | — |
| 0 (this device) | K103673 | Giardia/ Cryptosporidium Quik Chek | Techlab Inc., Corporate Research Center | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K912408 | Merifluor-Cryptosporidium/GiardiaSummary page 2…uorescent antibodies Persons Cryptosporidiuml and Antibody - against Giardia suspected of Glard/a Kit K91 2408 Cryptosparidium lmmuno- and having Glardia or occysts in feca… | 1991 |
| * | K033274 | Giardia IISummary page 2…specimens (IF)infection Detection of Hglspcfc Persons GIARDIA IIK033274 tiardia cyst ELISA antibodies ssetdo antigen in… | 2003 |
| * | K052932 | Cryptosporidium IISummary page 2…infection Detection of Highly specific Psstdo CRYPTOSPORIDIUM K052932 Cryptosporidium ELISA antibodies havingd o oocyst antigen in… | 2005 |
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K912408.
How does its category compare?
All MHI devicesMHI Giardia Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MHI
1in 2013
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
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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103673: Giardia/ Cryptosporidium Quik Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103673
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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