← Product Code [MHJ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MHJ) · K955345

# LMD CRYPTOSPORIDIUM ANTIGEN DETECTION (K955345)

_Lmd Laboratories · MHJ · Jun 7, 1996 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MHJ/K955345

## Device Facts

- **Applicant:** Lmd Laboratories
- **Product Code:** [MHJ](/submissions/MI/subpart-d%E2%80%94serological-reagents/MHJ.md)
- **Decision Date:** Jun 7, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3220
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Device Story

Upgraded Cryptosporidium Antigen Detection Assay; detects Cryptosporidium antigen in human stool specimens; used in clinical laboratory settings; provides qualitative results to assist in diagnosis of cryptosporidiosis; compared against conventional microscopic exam (CME) and original assay version; demonstrates improved sensitivity and specificity; no cross-reactivity with common intestinal parasites or pathogens.

## Clinical Evidence

Clinical study (n=130) using Mayo Clinic stool specimens. Compared upgraded assay to CME and original assay. Upgraded assay sensitivity 94% (95% CI: 85-99%), specificity 99% (95% CI: 93-100%). Original assay sensitivity 91% (95% CI: 80-97%), specificity 96%. Cross-reactivity testing performed against 15 organisms/cells (e.g., Giardia, Salmonella, rotavirus) with no cross-reactivity observed.

## Technological Characteristics

Antigen detection assay; immunological/biochemical detection principle; manual or semi-automated laboratory test format.

## Regulatory Identification

Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Entamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Predicate Devices

- LMD's original version Cryptosporidium Antigen Detection Assay

## Submission Summary (Full Text)

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K955345 JUN - 7 1996

# Summary of Safety and Effectiveness in Accordance with SMDA of 1990

Studies performed at LMD Laboratories compared the upgraded version of the Cryptosporidium Antigen Detection Assay against LMD's original version Cryptosporidium Antigen Detection Assay and Conventional Microscopic Exam (CME). The CME results, as well as virtually all of the samples, were obtained from Mayo Clinic. These samples are actual specimens submitted to Mayo Clinic Reference Laboratory for O&P examination.

The following results were obtained:

n=130

|  CME negative = 76 | Upgraded | Original  |
| --- | --- | --- |
|  CME positive = 54 | 75/76 were negative | 73/76 were negative  |
|   | 51/54 were positive | 49/54 were positive  |
|  Specificity =99% | 95% CI = 93 to 100% | Specificity =96%  |
|  Sensitivity = 94% | 95% CI = 85 to 99% | 95% CI = 89 to 99%  |
|   |  | Sensitivity = 91%  |
|   |  | 95% CI = 80 to 97%  |

The studies found no cross reactivity with stools containing the following organisms: Endolimax nana, Entamoeba histolytica, Entamoeba coli, Blastocystis hominus, Dientamoeba fragilis, Entamoeba hartmanni, Chilomastix mesnili, rotavirus, Giardia, Campylobacter jejuni, pinworm, Salmonella sp. and white blood cells.

![img-0.jpeg](img-0.jpeg)

David N. Lambillotte
President

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MHJ/K955345](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MHJ/K955345)

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