BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

• K Number: K991074
• Device Name: BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
• Manufacturer: INTRACEL CORP.
• Date Cleared: 1999-12-21 ( 265 days)
• Product Code: MJH
• Regulation Number: 866.3300

Intended Use

Bartels Legionella Urinary Antigen ELISA Test is intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease by qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine.

Device Description

Bartels Legionella Urinary Antigen ELISA Test is an enzyme-linked immunoassay intended for the qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine. The kit consists of microelisa stripwells with lid, positive and negative control reagents, conjugate, wash concentrate, colorimetric substrate (2 components) and stop solution. Sufficient materials are provided to perform 96 analyses. The microelisa wells have been pre-coated with purified rabbit antibodies to Legionella pneumophila Serotype 1 (capture antibody). An undiluted urine specimen (100 µL), or positive or negative controls (100 µL each) are each placed in a single microelisa well followed by the addition of 50 uL of Conjugate (horseradish peroxidase-conjugated rabbit antibodies to L. pneumophila). The loaded microelisa plate is then covered with the lid and incubated for 48 to 52 minutes at 34-37°C followed by 4 cycles of wash/aspiration using diluted Wash Solution (manual or automated wash procedure). Colorimetric substrate (tetramethyl benzidine/H2O2 100 µL/well) is then added and incubated for 10 to 12 minutes at 34-37℃ followed by the addition of Stop Solution (1M Phosphoric acid, 100 uL/well). The stopped plate is then read on a microelisa plate reader at 450 nm against an air blank. For a test to be considered valid, the Negative Control must have an optical density (OD) value of less than 0.100 and the Positive Control must be greater than the Positive Cutoff (pco). The pco is equal to 4X the O.D. value of the Negative Control value. Any specimen with an O.D. value ≥ the pco is considered positive. Any specimen with an O.D. value < the pco is considered negative. Alternatively, the results can be visually read. For this purpose, a visual interpretation card, and written instructions, are provided in the kit for interpretation of results. Any well that produces definite yellow color is considered to be positive.

Predicate Devices

Not Found (The text provides the name of the predicate device, but not its K/DEN number.)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard ELISA assay with optical density readings and a simple cutoff calculation for determining positive/negative results. There is no mention of AI/ML algorithms for data analysis or interpretation.

Therapeutic

No
This device is a diagnostic test kit intended to detect a specific antigen for the presumptive diagnosis of Legionnaires' Disease, not to treat or alleviate a medical condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the device is "intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease". This clearly indicates its use in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device is a laboratory test kit that utilizes chemical reagents and a physical assay process (ELISA) to detect an antigen in a urine sample. While it involves reading results, the core functionality is a chemical and biological reaction, not software processing of data.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states it's for the "qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information for a diagnosis.
• Device Description: The description details an "enzyme-linked immunoassay" that uses reagents to detect an analyte (Legionella antigen) in a biological sample (urine). This is a classic description of an in vitro diagnostic test.
• Performance Studies: The performance studies involve testing human urine specimens and comparing the results to a clinical diagnosis (culture-positive for Legionella or no diagnosis of Legionella). This is typical for validating an IVD.
• Predicate Device: The mention of a "Predicate Device" which is also an "EIA" (Enzyme Immunoassay) further confirms that this device falls under the category of IVDs.

The core function of the device is to analyze a human biological sample outside the body to aid in the diagnosis of a disease, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Bartels Legionella Urinary Antigen ELISA Test is intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease by qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine.

Product codes (comma separated list FDA assigned to the subject device)

MJH

Device Description

Bartels Legionella Urinary Antigen ELISA Test is an enzyme-linked immunoassay intended for the qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine. The kit consists of microelisa stripwells with lid, positive and negative control reagents, conjugate, wash concentrate, colorimetric substrate (2 components) and stop solution. Sufficient materials are provided to perform 96 analyses.

The microelisa wells have been pre-coated with purified rabbit antibodies to Legionella pneumophila Serotype 1 (capture antibody). An undiluted urine specimen (100 µL), or positive or negative controls (100 µL each) are each placed in a single microelisa well followed by the addition of 50 uL of Conjugate (horseradish peroxidase-conjugated rabbit antibodies to L. pneumophila). The loaded microelisa plate is then covered with the lid and incubated for 48 to 52 minutes at 34-37°C followed by 4 cycles of wash/aspiration using diluted Wash Solution (manual or automated wash procedure). Colorimetric substrate (tetramethyl benzidine/H2O2 100 µL/well) is then added and incubated for 10 to 12 minutes at 34-37℃ followed by the addition of Stop Solution (1M Phosphoric acid, 100 uL/well). The stopped plate is then read on a microelisa plate reader at 450 nm against an air blank. For a test to be considered valid, the Negative Control must have an optical density (OD) value of less than 0.100 and the Positive Control must be greater than the Positive Cutoff (pco). The pco is equal to 4X the O.D. value of the Negative Control value. Any specimen with an O.D. value ≥ the pco is considered positive. Any specimen with an O.D. value

Regulation Number and Section

§ 866.3300

Haemophilus spp. serological reagents.(a)
Identification. Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused byHaemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).(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.

Summary

0

DEC 2 1 1999

K991074

000018

510(k) SUMMARY

A. Name of Device and Classification

Bartels Legionella Urinary Antigen ELISA Test Trade Name:

Bartels Legionella Urinary Antigen ELISA Test is an enzyme-Classification: linked immunoassay that detects Legionella pneumophila Serogroup 1 antigen in human urine. This test has been classified as a Class II (performance standards) device, product code MJH (21 CFR 866.3300).

B. Legally Marketed Device

Bartels Legionella Urinary Antigen ELISA Test claims substantial equivalence to the Binax Legionella Urinary Antigen EIA.

C. Device Description

Bartels Legionella Urinary Antigen ELISA Test is an enzyme-linked immunoassay intended for the qualitative detection of Legionella pneumophila Serogroup 1 antigen in human urine. The kit consists of microelisa stripwells with lid, positive and negative control reagents, conjugate, wash concentrate, colorimetric substrate (2 components) and stop solution. Sufficient materials are provided to perform 96 analyses.

The microelisa wells have been pre-coated with purified rabbit antibodies to Legionella pneumophila Serotype 1 (capture antibody). An undiluted urine specimen (100 µL), or positive or negative controls (100 µL each) are each placed in a single microelisa well followed by the addition of 50 uL of Conjugate (horseradish peroxidase-conjugated rabbit antibodies to L. pneumophila). The loaded microelisa plate is then covered with the lid and incubated for 48 to 52 minutes at 34-37°C followed by 4 cycles of wash/aspiration using diluted Wash Solution (manual or automated wash procedure). Colorimetric substrate (tetramethyl benzidine/H2O2 100 µL/well) is then added and incubated for 10 to 12 minutes at 34-37℃ followed by the addition of Stop Solution (1M Phosphoric acid, 100 uL/well). The stopped plate is then read on a microelisa plate reader at 450 nm against an air blank. For a test to be considered valid, the Negative Control must have an optical density (OD) value of less than 0.100 and the Positive Control must be greater than the Positive Cutoff (pco). The pco is equal to 4X the O.D. value of the Negative Control value. Any specimen with an O.D. value ≥ the pco is considered positive. Any specimen with an O.D. value