(199 days)
None
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No
The summary describes a laboratory assay for detecting Cryptosporidium antigen and compares its performance to a conventional microscopic exam. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on sensitivity and specificity of the assay itself.
No
This device is described as a Cryptosporidium Antigen Detection Assay, which is used for diagnostic purposes (detection of an antigen) rather than providing therapy.
Yes
The device is described as a "Cryptosporidium Antigen Detection Assay," and performance studies compare it against a "Conventional Microscopic Exam (CME)" for detecting Cryptosporidium. The inclusion of sensitivity and specificity metrics further implies its role in diagnosing a condition.
No
The summary describes a "Cryptosporidium Antigen Detection Assay" and performance studies comparing it to a "Conventional Microscopic Exam (CME)". This strongly suggests a laboratory-based assay involving physical samples and potentially reagents, not a software-only device. The performance studies focus on the assay's ability to detect an antigen in stool samples, which is characteristic of an in vitro diagnostic (IVD) device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It's an "Assay": The description explicitly refers to the device as a "Cryptosporidium Antigen Detection Assay." Assays are tests performed outside of the body to detect specific substances, which is a core characteristic of IVDs.
- It analyzes biological samples: The test is performed on "stools" and "specimens submitted... for O&P examination," which are biological samples.
- It detects a specific analyte: The assay detects "Cryptosporidium Antigen," a specific substance found in biological samples.
- It's used for diagnostic purposes: The purpose of detecting Cryptosporidium antigen is to aid in the diagnosis of Cryptosporidium infection.
- Performance is compared to a "Conventional Microscopic Exam (CME)": CME is a standard diagnostic method, and comparing the assay's performance to it further indicates its diagnostic intent.
- Sensitivity and Specificity are reported: These are key performance metrics for diagnostic tests.
While the "Intended Use / Indications for Use" section is missing, the information provided in the "Device Description," "Summary of Performance Studies," and "Key Metrics" sections strongly indicates that this device is an in vitro diagnostic intended to detect Cryptosporidium antigen in biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 CME positive = 54 Upgraded 75/76 were negative 51/54 were positive Original 73/76 were negative 49/54 were positive
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Upgraded: Specificity =99% 95% Cl = 93 to 100% Sensitivity = 94% 95% CI = 85 to 99%. Original: Specificity =96% 95% CI = 89 to 99% Sensitivity = 91% 95% CI = 80 to 97%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba 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.(b)
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.
0
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 CME positive = 54
Upgraded 75/76 were negative 51/54 were positive
Specificity =99% 95% Cl = 93 to 100% Sensitivity = 94% 95% CI = 85 to 99%
Original 73/76 were negative 49/54 were positive
Specificity =96% 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.
Signature
David N. Lambillotte President