(494 days)
BioWhittaker HSV ELISA II IgG
No
The description details a standard chemiluminescent enzyme immunoassay and does not mention any AI or ML components. The performance studies focus on traditional metrics like sensitivity and specificity, not AI/ML model performance.
No
The device is described as an "in vitro diagnostic use as an aid in the determination of serological status to HSV I & II," not for treating or preventing a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended strictly for in vitro diagnostic use as an aid in the determination of serological status to HSV I & II." This indicates its purpose is to provide information for diagnosis.
No
The device description clearly states it is a "solid-phase, two-step, chemiluminescent enzyme immunoassay" utilizing a "polystyrene bead enclosed within an IMMULITE® Test Unit" coated with viral antigen. This describes a physical, 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: "It is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to HSV I & II." This is the primary indicator of an IVD.
- Device Description: The description details a "solid-phase, two-step, chemiluminescent enzyme immunoassay" that uses a "polystyrene bead enclosed within an IMMULITE® Test Unit" coated with viral antigen. This describes a laboratory test performed on biological samples (human serum).
- Performance Studies: The document describes clinical performance studies conducted using human serum samples to evaluate the device's accuracy in detecting antibodies. This is typical for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K822883) indicates that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for IVDs.
All of these elements strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
IMMULITE Herpes I & II IgG is designed for the qualitative detection of IgG antibodies to herpes simplex virus (HSV) type I & II in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to HSV I & II.
Product codes
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Device Description
IMMULITE Herpes I & II IgG is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer.
IMMULITE® Herpes I & II 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 HSV I and II viral antigen.
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
The clinical performance of the IMMULITE Herpes I & II IgG assay was studied at Diagnostic Products Corporation (DPC) using a CMV/HSV proficiency panel obtained from the United States Centers for Disease Control and Prevention (CDC).
The in-house (DPC) retrospective study was conducted by assaying the CDC serum panel with the IMMULITE Herpes I & II IgG assay and sending the results to the CDC for unmasking.
Studies on the clinical performance of the IMMULITE Herpes I & II IgG assay and the BioWhittaker HSV ELISA II IgG assay were also conducted nonconcurrently at two independent sites.
Summary of Performance Studies
The in-house (DPC) retrospective study was conducted by assaying the CDC serum panel with the IMMULITE Herpes I & II IgG assay and sending the results to the CDC for unmasking. The panel consisted of 72% positive and 28% negative samples. IMMULITE Herpes I & II IgG demonstrated 97% total agreement with the CDC results obtained by IMMULITE, there was 99% agreement with the positive specimens and 93% agreement with the negative results.
Studies on the clinical performance of the IMMULITE Herpes I & II IgG assay and the BioWhittaker HSV ELISA II IgG assay were also conducted nonconcurrently at two independent sites. A summary of the results is shown in the table below.
Site I: n = 200
Site 2: n = 202
Key Metrics
CDC Results:
Total agreement: 97%
Agreement with positive specimens: 99%
Agreement with negative results: 93%
IMMULITE vs BioWhittaker (Site I):
Agreement: 99.0%
Relative Sensitivity: 100.0%
Relative Specificity: 96.6%
IMMULITE vs BioWhittaker (Site 2):
Agreement: 96.0%
Relative Sensitivity: 96.2%
Relative Specificity: 94.9%
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
0
Diagnostic Products Corporation 5700 West 96th Street
Los Angeles, CA 90045 Tel: (213) 776-0180 Fax: (213) 776-0204
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JUN 21 1906
510 (k) Summary Safety and Effectiveness
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: | Diagnostic Products Corporation |
|---|---|
| Address: | 5700 West 96th Street |
| Los Angeles, California 90045 | |
| Telephone Number: | (213) 776-0180 |
| Facsimile Number: | (213) 776-0204 |
| Contact Person: | Edward M. Levine, Ph.D. |
| Date of Preparation: | March 28, 1996 |
| Device Name: | IMMULITE Herpes I & II IgG |
| Trade: | LKHSZ (50 tests); LKHS2 (200 tests) |
| Common: | Reagent system for the determination of Herpes I & II IgG antibodies in human serum. |
| Classification: | Class III device (866.3305) |
| Manufacturer: | EURO/DPC, a wholly-owned subsidiary of Diagnostic Products Corporation. (Manufacturing under a Quality System - ISO 9001/EN29001/BS 5750/part 1) |
| Establishment Registration #: | EURO/DPC: Not Applicable |
| DPC: 2017183 | |
| Substantially Equivalent Predicate Device: | BioWhittaker HSV ELISA II IgG (K822883) |
| Description of Device: | IMMULITE Herpes I & II IgG is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer |
| Intended Use of the Device: | IMMULITE Herpes I & II IgG is designed for the qualitative detection of IgG antibodies to herpes simplex virus (HSV) type I & II in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to HSV I & II. |
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ostic Products Corporation Wast afith Street Fax: (213) 776-0204
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Summary and Explanation of the Test:
Herpes simplex virus (HSV) is an ancient and ubiquitous virus, known to cause and recurrent infections in humans. The virus enters the mucous membranes (ocular, genital, or oral) and replicates locally and may enter the sensory root ganglion, resulting in latent, recurrent infections. Infection of neonates during passage through the birth canal may result in neurological damage and death.
In the 1960s it was recognized that HSV consisted of two distinct types, HSV-II. HSV-I is considered to be primarily associated with ocular and oral infection, while HSV-II is considered to be a genital infection. However, HSV types I and II share several common antigens, and the use of specific monoclonal antibodies or restriction endonuclease mapping is required to type individual strains.
Infections with HSV type I or type II can differ in their clinical manifestations and severity. The immune response of the host can play an important role in controlling the severity of primary or reactivated infections. Those at highest risk for severe infections are neonates, who are infected during delivery, and immunocompromised patients.
While isolation of the virus in tissue culture is recommended for the diagnosis of active infections, serological testing can provide valuable information in the management of at-risk populations, such as pregnant women.
Summary and Explanation of the Device:
IMMULITE® Herpes I & II 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 HSV I and II viral antigen.
- Prediluted patient sample (1-in-21 dilution: 1 part in a total of 21 parts) 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, Herpes I and II IgG in the sample binds to the HSV I and II 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 a further 10 minutes .
The chemiluminescent substrate, PPD (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 a sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is related to the presence of HSV I and II IgG in the sample. A qualitative result is then obtained by comparing the patient result to an established Cutoff.
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Diagnostic Products Corporation 0 West 96th Street s Angeles, CA 90045 (213) 776-0180 Fax: (213) 776-0204
Performance Equivalence - Technology Comparison:
Diagnostic Products Corporation (DPC) asserts that IMMULITE® Herpes I & II IgG is substantially equivalent to the HSV ELISA II IgG kit marketed by BioWhittaker Inc.(Walkersville, MD).
Each product is designed for the detection of IgG antibodies to HSV I & II virus in human serum. Each product is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to HSV I & II.
IMMULITE® Herpes I & II IgG is a chemiluminescent enzyme immunoassay and the HSV ELISA II IgG test is an enzyme-linked immunosorbent assay (ELISA). The technology in DPC's IMMULITE® Herpes I & II IgG is identical to technology used in previously cleared and commercially marketed IMMULITE® products.
In the BioWhittaker HSV ELISA II IgG assay, partially purified herpes antigen is attached to the surface of microplate wells. Diluted patient serum is added to the wells, and the herpes specific antibody, if present, binds to the antigen. All unbound antibody is washed away and enzyme-conjugated anti-human IgG is added. The enzyme conjugate binds to the antibody-antigen Excess enzyme conjugate is washed away and substrate is added. Bound enzyme complex. conjugate begins a hydrolytic reaction. After a specified time, the enzyme reaction is stopped. The intensity of the color generated is proportional to the amount of herpes IgG specific antibody in the sample. The results are read by a spectrophotometer, producing an indirect measurement of the herpes IgG specific antibody in the serum.
Performance Equivalence - Method Comparison:
The clinical performance of the IMMULITE Herpes I & II IgG assay was studied at Diagnostic Products Corporation (DPC) using a CMV/HSV proficiency panel obtained from the United States Centers for Disease Control and Prevention (CDC).
The in-house (DPC) retrospective study was conducted by assaying the CDC serum panel with the IMMULITE Herpes I & II IgG assay and sending the results to the CDC for unmasking. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
The panel consisted of 72% positive and 28% negative samples. IMMULITE Herpes I & II IgG demonstrated 97% total agreement with the CDC results obtained by IMMULITE, there was 99% agreement with the positive specimens and 93% agreement with the negative results.
Studies on the clinical performance of the IMMULITE Herpes I & II IgG assay and the BioWhittaker HSV ELISA II IgG assay were also conducted nonconcurrently at two independent sites. A summary of the results is shown in the table below.
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Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045
Tel: (213) 776-0180 Fax: (213) 776-0204
Image /page/3/Picture/1 description: The image shows the logo for DPC. The logo is in black and white and features the letters "DPC" in a bold, sans-serif font. The letters are connected to each other, and there is a registered trademark symbol to the right of the letter "C". The logo is simple and modern.
: $ 201
Performance Equivalence - Method Comparison (continued):
| | IMMULITE vs.
BioWhittaker (Site I) | IMMULITE vs.
BioWhittaker (Site 2) |
|----------------------|---------------------------------------|---------------------------------------|
| Agreement | 99.0% | 96.0% |
| Relative Sensitivity | 100.0% | 96.2% |
| Relative Specificity | 96.6% | 94.9% |
| n = | 200 | 202 |
Conclusion:
i
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 Levine
Edward M. Levine, Ph.D. Manager of Clinical Affairs
4/3/96
Date