# K232672: EasyScreen Gastrointestinal Parasite Detection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Genetic Signatures Limited
- Decided: May 29, 2024 after 271 days
- Product code: PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN130003 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143648: BD MAX Enteric Parasite Panel, BD MAX Instrument, Becton, Dickinson and Company (2015) Summary page 5.

## Indications for use
The Genetic Signatures EasyScreen TM Gastrointestinal Parasite Detection Kit is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic gastrointestinal parasite nucleic acid from the stool of patients with signs and/or symptoms of gastroenteritis. The test, based on real-time PCR, detects the nucleic acid of the following organisms: * Cryptosporidium spp. * Giardia intestinalis * Dientamoeba fragilis * Entamoeba histolytica * Blastocystis hominis * Enterocytozoon bieneusi * Encephalitozoon intestinalis * Cyclospora cayetanensis The kit is compatible with stool specimens that are unpreserved or frozen or in transport media including Cary Blair or C&S media from symptomatic patients with suspected gastroenteritis. It is required that the stool is first processed using the EasyScreenTM Sample Processing Kit. Nucleic acid extraction and real-time PCR set up are performed on the automated Genetic Signatures GS1 platform. The EasyScreenTM Gastrointestinal Parasite Detection Kit includes all reagents required to detect the specific protozoan gene sequences using real-time PCR amplification of the extracted nucleic acids and fluorogenic target-specific hybridization probes for the detection of the amplified nucleic acid. The EasyScreen TM Gastrointestinal Parasite Detection kit also incorporates an Extraction Control (EC) and an Internal Positive Control (IPC) to ensure the reliability of the extracted nucleic acid and to detect the presence of any inhibitors, respectively. This device is an in vitro diagnostic (IVD) intended to be used by trained personnel in clinical, pathology or hospital laboratories as an aid in the diagnosis of gastrointestinal illness. This test is intended for use, in conjunction with clinical presentation, laboratory findings, and epidemiological information, as an aid in the differential diagnosis of infections by Dientamoeba fragilis, Blastocystis hominis, Enterocytozoon bieneusi, Cyclospora cayetanensis, Entamoeba histolytica, Encephalitozoon intestinalis, Cryptosporidium spp. (including C. hominis and C. parvum), and Giardia intestinalis. Results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decision. Positive results do not rule out co-infection with other organisms that are not detected by this test, and may not indicate the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis and/or colitis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

Source page: https://510kreport.com/device/K232672
Methodology: https://510kreport.com/methodology