# K982245: Triage,Parasite Panel, Triage Cryptosporidium and Entamoeba Histolytica, Triage Cryptosporidium and Giardia Lamblia

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Oct 6, 1998 after 102 days
- Product code: MHI (Giardia Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Single Test Kits manufactured by Alexon: named in the summary without a submission number
- (no number) Single Test Kits manufactured by TechLabs: named in the summary without a submission number
- (no number) Single Test Kits manufactured by Meridian Diagnostics: named in the summary without a submission number
- (no number) Enzyme immunoassay tests manufactured by Trend: named in the summary without a submission number
- (no number) Enzyme immunoassay tests manufactured by LMD laboratories: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K982245
Methodology: https://510kreport.com/methodology