K Number

Device Name

LEGIONELLA IGG/IGM ELISA TEST SYSTEM

Manufacturer

ARMKEL, LLC.

Date Cleared

1997-03-03

(192 days)

Product Code

LHL

Regulation Number

866.3300

Intended Use

for the qualitative detection of total antibodies (IgG and IgM) 10 Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.

Device Description

The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) 10 Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. The Legionella pneumophila IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgG/IgM antibodies to Legionella. Purified Legionella pneumopilla antigen (serogroups 1, 2, 3, 4, 5, 6) is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG/IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

BioWhitttaker's Legionella STAT test.

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard ELISA assay, which is a biochemical test. There is no mention of AI/ML in the device description, intended use, or performance studies.

Therapeutic

This device is designed for the qualitative detection of antibodies to Legionella pneumophila, which is a diagnostic function to determine the presence of disease, not to treat or prevent it.

Diagnostic

Yes
The intended use and device description clearly state that this device is for the "qualitative detection of total antibodies (IgG and IgM) 10 Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease," which is a diagnostic purpose. The performance studies also report metrics typically used for diagnostic devices like sensitivity and specificity.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical ELISA kit with reagents, microtiter wells, and a process involving chemical reactions and photometric measurement, indicating it is a hardware-based diagnostic test, not software only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states it's for the "qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease." This indicates it's used to test human specimens (serum) to provide information for diagnosis.
Device Description: The description details an "Enzyme-Linked Immunosorbent Assay (ELISA)" which is a common laboratory technique used for in vitro diagnostic testing. It describes the process of using patient serum and reagents to detect antibodies.
Performance Studies: The inclusion of performance studies (sensitivity, specificity, precision) is typical for IVD devices to demonstrate their analytical and clinical performance.
Predicate Device: The mention of a "Predicate Device" (BioWhitttaker's Legionella STAT test) is a regulatory requirement for submitting new IVD devices, further confirming its classification.

All these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Legionella pneumophila IgG/IgM ELISA test is an enzyme linked immunosorbent assay to detect IgG/IgM antibodies to Legionella. Purified Legionella pneumopilla antigen (serogroups 1, 2, 3, 4, 5, 6) is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG/IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

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

Not Found

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Relative sensitivity and specificity:
- Study 1: Evaluated relative to Legionella Stat at a commercial R&D lab in Maryland.
  - Sample size: 33 single IFA positive sera from an outbreak and routinely submitted samples.
  - Relative Sensitivity = 27/30 = 90.00% (95% Confidence interval = 79.0% - 100%).
  - Relative Specificity = NA (95% Confidence interval = NA).
- Study 2: Evaluated at a clinical laboratory in Pennsylvania.
  - Sample size: 72 prospective serum for Legionella testing.
  - Relative Specificity = 67/68 = 98.53% (95% Confidence interval = 95.6% - 100%).
  - Relative Agreement = 69/70 = 98.57% (95% Confidence interval = 95.7% - 100%).
Precision:
- Seven different sera assayed at two different sites.
- An additional three sera were tested at site 1.
- Each serum was tested ten times on three different days at each of the two study sites.
- Intra and inter-assay precision presented in Tables 5 and 6, inter-site coefficient of variation (CV) in Table 7.
IFA Paired Serum Analysis (CDC Panel):
- Serum panel tested at the CDC by IFA, confirmed serologically positive for an increase in titer from 1:256.
- Sample size: 31 serum pairs showing a greater than 4 fold increase in IFA titer.
- Sensitivity = 29/31 = 93.5% in detecting seroconversions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Relative Sensitivity = 90.00% (95% Confidence interval = 79.0% - 100%)
Relative Specificity = 98.53% (95% Confidence interval = 95.6% - 100%)
Relative Agreement = 98.57% (95% Confidence interval = 95.7% - 100%)
Sensitivity in detecting seroconversions = 93.5%

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.

BioWhitttaker's Legionella STAT test.

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.

Not Found

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).

Not Found

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

2,25181 - 4.52

K963318

Coc 543

Summary of Safety and Effectiveness Information Legionella pneumophila IgG/IgM ELISA Test Kit

MAR - 3 1997

I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: Feb 13, 1997

II. Description of Device

】!【. Predicate Device

The Legionella pneumophila IgG/IgM ELISA test is substantially equivalent to BioWhitttaker's Legionella STAT test. Equivalence is demonstrated by the following comparative results:

Performance Characteristics

Relative sensitivity and specificity. The Legionella pneumophila LyG/ IgM EL.ISA was evaluated relative to Legionella Stat at two different sites. The first site was a commercial R&D lab located in Maryland. Thirty three single IFA positive sera from an outbreak and samples routinely submitted for Legionella testing were tested. The study are summarized in Table 3.

Table 3 Comparison of Legionella pneumophila IgG/IgM ELISA and Legionella IFA

Wampole Legionella pneumophila IgG/IgM ELISA

			eq		Total
	+ ≥256	27	ﻢ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ		33
IFA	- >256	0	0	0	()
	Total	27	ﻢ ﺍﻟﻤﺮﺍﺟﻊ	3	33

Relative Sensitivity = 27/30 = 90.00%	95% Confidence interval = 79.0% - 100%
Relative Specificity = NA	95% Confidence interval = NA

Equivocals were not included in the above calculations. The 95% confidence intervals were calculated using the normal method.

Please be advised that 'relative' refers to the comparison of this assay's results to that of similar assay. There was not an attempt to correlate the assay's results with disease presence or absence No judgment can be made on the comparison assay's accuracy to predict disease.

Wampole Legionellu pneumophila IgG/IgM ELISA

43 543

The second site was a clinical laboratory located in Pennsylvania. Seventy two prospective serum for Legionella testing were tested. The results of the study are summarized in Table 4.

Table 4 Comparison of Legionella pneumophila IgG/IgM ELISA and Legionella IFA

		+	eq	-	Total
IFA	+ ≥256	2	0	0	2
	- 1:256. The sera were submitted to CDC for titer conformation. The results are presented as a means to convey further information on the performance of this assay with a masked serum panel. This does not imply an endorsement of the assay by the CDC.

The panel consists of 31 serum pairs showing a greater than 4 fold increase in IFA titer. Each serum pair was evaluated on the Legionella preumophila IgG/IgM ELISA assay to determine an seroconversion in antibody. Twenty nine pairs had a seroconversion thus giving a sensitivity of 29/31 = 93.5% in detecting seroconversions.