(269 days)
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No
The device description details a standard chemiluminescent enzyme immunoassay process. There is no mention of AI/ML terms, image processing, or any description of training/test sets typically associated with AI/ML models. The performance studies compare the device to predicate devices using standard clinical metrics, not AI/ML-specific metrics.
No.
The device is designed for in vitro diagnostic use to detect antibodies, aiding in the determination of serological status; it does not treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended strictly for in vitro diagnostic use as an aid in the determination of serological status to Toxoplasma gondii." This clearly indicates its role in diagnosing or aiding in the diagnosis of a medical condition.
No
The device description clearly outlines a physical, solid-phase immunoassay involving chemical reactions, incubation, washing, and measurement of light emission using a luminometer. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended strictly for in vitro diagnostic use".
- Device Description: The description details a laboratory test performed on a human sample (serum) to detect a specific analyte (IgG antibodies to Toxoplasma gondii). This is a hallmark of an in vitro diagnostic test.
- Performance Studies: The document describes clinical performance studies comparing the device to other established diagnostic assays (VIDAS® and IMx® Toxoplasma IgG assays), which is a requirement for demonstrating the validity of an IVD.
- Predicate Devices: The mention of predicate devices (VIDAS® Toxo IgG and IMx® Toxo IgG) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
N/A
Intended Use / Indications for Use
IMMULITE Toxoplasma Quantitative IgG is designed for the quantitative detection of IgG antibodies to Toxoplasma gondii in human serum and is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to Toxoplasma gondii.
Product codes
866.3780
Device Description
IMMULITE Toxoplasma Quantitative IgG is a clinical device for use with the IMMULITE Automated Immunoassav Analyzer. IMMULITE® Toxoplasma Quantitative IgG is a solid-phase, two-step, chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a partially purified Toxoplasma gondii antigen, strain RH. Prediluted patient sample (1-in-21 dilution) and a protein-based buffer are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, toxoplasma IgG in the sample binds to the toxoplasma antigen-coated bead. Unbound serum is then removed by a centrifugal wash. An alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for an additional 10 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus the photon output, as measured by the luminometer - is directly related to the quantity of toxoplasma IgG in the sample. A quantitative result in IU/mL is then obtained by comparing the patient result to a stored Master Curve, and which is adjusted to the response of each analyzer.
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)
The clinical performance of the IMMULITE Toxoplasma IgG procedure was compared to the VIDAS® and IMx® Toxoplasma IgG assays, using a total of 199 serum specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| IMMULITE vs.VIDAS® | IMMULITE vs.IMx® | |
|---|---|---|
| Agreement | 99.0% | 96.4% |
| Sensitivity | 96.3% | 90.2% |
| Specificity | 100.0% | 98.6% |
| n= | 199 | 194 |
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
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§ 866.3780
Toxoplasma gondii serological reagents.(a)
Identification. Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toToxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyToxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoanToxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.(b)
Classification. Class II (performance standards).
0
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 (213) 776-0180 Tel: Fax: (213) 776-0204
KG62936
510(k) Summary
APR 2 4 1997
Safety and Effectiveness
Image /page/0/Picture/5 description: The image shows a logo with three bold, stylized letters. The letters appear to be "PFC", with the "P" on the left, the "F" in the middle, and the "C" on the right. A small registered trademark symbol is located in the upper right corner of the logo. The logo is black and the background is white.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
Name: Address: Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Telephone Number: Facsimile Number:
Contact Person:
Date of Preparation: Device Name: Proprietary Name: Catalog Number: Common:
Image /page/0/Picture/31 description: The image shows a logo with the text "ARS" at the bottom. Above the text is a globe with the words "EXCELLENCE in DIAGNOSTICS" surrounding the top half of the globe. The globe is black and white and appears to be a stylized representation of the earth.
Classification:
Manufacturer:
(213) 776-0280
Edward M. Levine, Ph.D. Manager of Clinical Affairs
July 25, 1996
(213) 776-0180
IMMULITE® Toxoplasma Quantitative IgG LKTX01 (100 tests); LKTXQ5 (500 tests) Reagent system for the determination of Toxoplasma gondii IgG antibodies in human serum. Class II device (866.3780)
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Establishment Registration #:
Substantially Equivalent Predicate Device:
Description of Device:
Intended Use of the Device:
DPC's Registration # is 2017183
bioMerieux Vitek VIDAS® Toxo IgG Abbott Laboratories IMx® Toxo IgG
IMMULITE Toxoplasma Quantitative IgG is a clinical device for use with the IMMULITE Automated Immunoassav Analyzer.
IMMULITE Toxoplasma Quantitative IgG is designed for the quantitative detection of IgG antibodies to Toxoplasma gondii in human serum and is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to Toxoplasma gondii.
Summary and Explanation of the Device:
IMMULITE® Toxoplasma Quantitative IgG is a solid-phase, two-step, chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a partially purified Toxoplasma gondii antigen, strain RH
Prediluted patient sample (1-in-21 dilution) and a protein-based buffer are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent
1
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 IMMULITE® Toxoplasma Quantitative IgG 510(k) Summary of Safety and Effectiveness Page 2 of 2
Summary and Explanation of the Device (continued):
agitation. During this time, toxoplasma IgG in the sample binds to the toxoplasma antigen-coated bead. Unbound serum is then removed by a centrifugal wash.
An alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for an additional 10 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus the photon output, as measured by the luminometer - is directly related to the quantity of toxoplasma IgG in the sample. A quantitative result in IU/mL is then obtained by comparing the patient result to a stored Master Curve, and which is adjusted to the response of each analyzer.
Summary of Studies:
The clinical performance of the IMMULITE Toxoplasma IgG procedure was compared to the VIDAS® and IMx® Toxoplasma IgG assays, using a total of 199 serum specimens. A summary of the results is shown in the table below.
| | IMMULITE vs.
VIDAS® | IMMULITE vs.
IMx® |
|-------------|------------------------|----------------------|
| Agreement | 99.0% | 96.4% |
| Sensitivity | 96.3% | 90.2% |
| Specificity | 100.0% | 98.6% |
| n= | 199 | 194 |
Conclusion:
The conclusions drawn from the clinical and nonclinical studies demonstrate that the device is safe, effective, and performs as well as, or better, than the current legally marketed devices.
Edward M. Lewis, Ph.D.
Edward M. Levine, Ph.D. Manager of Clinical Affairs
H/45/E.G
Date