TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA

• K Number: K982245
• Device Name: TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
• Manufacturer: BIOSITE INCORPORATED
• Date Cleared: 1998-10-06 ( 102 days)
• Product Code: MHI , GMO , MHJ
• Regulation Number: 866.3220
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Triage® Parasite Panel is an enzyme immunoassay used for the detection of antigens for Entamoeba histolyticaldispar, 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.

Device Description

The Triage® Parasite Panel is an enzyme immunoassay used to detect the presence of parasite specific antigens in human fecal specimens. It is a membrane based immunoassay that depends on the detection of the antigen using antibodies with specificities to at least two distinct antigenic sites on the molecule.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Triage® Parasite Panel, based on the provided text:

Acceptance Criteria and Reported Device Performance

For Giardia lamblia:

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Sensitivity	Comparable to O&P	95.1%
Specificity	Comparable to O&P	88.4%
Positive Predictive Value	Not specified	79.4%
Negative Predictive Value	Not specified	97.4%
Agreement (95% CI)	Not specified	87.8% - 93.3%

For Entamoeba histolytica/dispar:

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Sensitivity	Comparable to O&P	90.5%
Specificity	Comparable to O&P	85.0%
Positive Predictive Value	Not specified	38.8%
Negative Predictive Value	Not specified	98.8%
Agreement (95% CI)	Not specified	82.3% - 88.8%

For Cryptosporidium parvum:

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Sensitivity	Comparable to O&P	91.4%
Specificity	Comparable to O&P	98.2%
Positive Predictive Value	Not specified	88.3%
Negative Predictive Value	Not specified	98.7%
Agreement (95% CI)	Not specified	95.8% - 98.8%

General Acceptance Criteria (Implied):
The primary implied acceptance criteria are that the Triage® Parasite Panel produce "essentially the same results" as:

1. Recognized standard methods for parasite identification in stool specimens (i.e., traditional O&P examination).
2. Other commercially available immunoassays.

The document specifically states that "statistical analysis of the data showed that the sensitivity of the three tests contained in the Triage® Parasite Panel was not statistically different from those of commercially available immunoassays" reported to have similar sensitivities when compared to microscopic techniques. Similarly, "there was not a statistical difference in the specificity of the Triage® G. lamblia or the C. parvum tests" compared to commercial tests with reported 98% specificity. The specificity of the Triage® E. histolytica test was even "significantly greater" than a commercially available immunoassay.

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Giardia lamblia: 444 fecal specimens
   • Entamoeba histolytica/dispar: 443 fecal specimens
   • Cryptosporidium parvum: 444 fecal specimens
   • Data Provenance: Not explicitly stated regarding country of origin. The study was conducted using both "positive and negative stool specimens," implying they were clinical samples, though whether retrospective or prospective is not specified.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not explicitly stated. The ground truth was established by "standard ova and parasite examination using Modified Acid Fast Staining and Trichrome Staining procedures." This implies trained laboratory personnel, but the specific number or qualifications are not provided.

3. Adjudication Method for the Test Set:

   • Not explicitly stated. The document describes comparison to "standard ova and parasite examination." For discrepancies, specimens producing apparent false positive results with the Triage® Parasite Panel were "evaluated using other commercially available enzyme immunoassays." This suggests a form of secondary evaluation or adjudication for discrepant results.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. This study compares the device's performance to traditional laboratory methods and other immunoassays, not human reader performance with or without AI assistance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, this was a standalone study. The Triage® Parasite Panel is an enzyme immunoassay, which is a laboratory test and not an AI algorithm. Its performance was evaluated independently against the ground truth.

6. The Type of Ground Truth Used:

   • Expert Consensus / Reference Method: The ground truth was established by "standard ova and parasite examination using Modified Acid Fast Staining and Trichrome Staining procedures." This is considered a reference laboratory method for detecting parasites. However, the document acknowledges that "Conventional microscopic examination of fecal specimens has been demonstrated to be less sensitive than other scientifically valid techniques," and refers to it as not "ideal for the detection of the organisms."

7. Sample Size for the Training Set:

   • Not applicable. This is an immunoassay, not a machine learning model, so there is no "training set" in the context of AI.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this type of device.

Regulation Number and Section

§ 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.