LMD Cryptosporidium Antigen Detection

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K955345 ↗

FDA Product Code

MHJ

Device Class

Class II

Regulation

21 CFR Part 866.3220

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Cryptosporidium Antigen Detection

  Class II

  FDA 510(k) K905598 Active Cleared 5 Sep 1991

• Entamoeba Histolytica-Positive Control(Rabbit)

  Class II

  FDA 510(k) K854017 Active Cleared 22 Oct 1985

• Cysticercosis Serological Reagents

  Class I

  FDA 510(k) K900780 Active Cleared 4 Oct 1990

• Trichinella Serology Microtiter Elisa

  Class I

  FDA 510(k) K904613 Active Cleared 21 Mar 1991

• Giardia Stool Antigen Test Kit

  Class II

  FDA 510(k) K890003 Active Cleared 14 Mar 1989

• Lmd Giardia Antigen Detection Assay

  Class II

  FDA 510(k) K944871 Active Cleared 22 Jun 1995

See all devices from Lmd Laboratories →

• What is the LMD CRYPTOSPORIDIUM ANTIGEN DETECTION device used for?

  The LMD CRYPTOSPORIDIUM ANTIGEN DETECTION device is used to detect Cryptosporidium spp. antigen in human stool specimens. It provides qualitative results that assist clinical laboratories in the diagnosis of cryptosporidiosis, a gastrointestinal infection caused by the parasite Cryptosporidium.

• What type of specimen is required for the LMD CRYPTOSPORIDIUM ANTIGEN DETECTION test?

  The device requires human stool specimens for testing. It is specifically designed to detect Cryptosporidium antigen in these samples, making it suitable for use in clinical microbiology laboratories evaluating patients with suspected parasitic gastrointestinal illness.

• Is the LMD CRYPTOSPORIDIUM ANTIGEN DETECTION device a qualitative or quantitative test?

  The LMD CRYPTOSPORIDIUM ANTIGEN DETECTION device provides qualitative results, meaning it reports whether Cryptosporidium antigen is present or absent in the specimen, rather than measuring the amount of antigen. This format supports diagnostic decision-making in clinical settings.

• What regulatory pathway was used for the LMD CRYPTOSPORIDIUM ANTIGEN DETECTION device?

  The device received FDA 510(k) clearance under submission number K955345, indicating it was found substantially equivalent to a legally marketed predicate device. This traditional 510(k) pathway is used for moderate-risk Class II medical devices like this assay.

• How is the LMD CRYPTOSPORIDIUM ANTIGEN DETECTION device classified by the FDA?

  The device is classified as a Class II medical device under FDA regulation 866.3220, with product code MHJ. This classification reflects its moderate risk level and subjects it to special controls, including performance standards and post-market surveillance, to ensure safety and effectiveness.