(140 days)
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No
The device description details a standard ELISA assay and mentions manual use or use with a specific instrument (Duet™), but there is no mention of AI, ML, or any computational analysis beyond standard plate reader interpretation. The performance data is based on traditional statistical metrics for diagnostic tests.
No.
The device is an in vitro diagnostic test used to detect antibodies for diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of herpes simplex virus associated disease." Additionally, the "Device Description" states it is "an in vitro diagnostic medical device." These phrases directly indicate its diagnostic purpose.
No
The device description clearly outlines a physical kit containing reagents, plates, and other components for an ELISA assay. While it mentions potential use with an instrument (DUET™), the core device is a collection of physical materials, not software.
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 "to be used... in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted... and as an aid in the diagnosis of herpes simplex virus associated disease." This clearly describes a test performed on a sample taken from the human body to provide information for diagnosis.
- Device Description: The "Device Description" section further clarifies that it is an "in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus (HSV) in human serum by the enzyme-linked immunosorbent assay (ELISA) method." The term "in vitro diagnostic medical device" is a direct identifier of an IVD.
- Method: The description of the ELISA method, which involves testing a sample (serum) outside of the body, is characteristic of an in vitro test.
Therefore, based on the provided information, the HSV 1+2 IgG ELISA TEST is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HSV 1+2 IgG ELISA TEST is to be used manually or in conjunction with the Duet™ instrument in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus associated disease.
Product codes (comma separated list FDA assigned to the subject device)
LGC
Device Description
The HSV 1+2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus (HSV) in human serum by the enzyme-linked immunosorbent assay (ELISA) method.
The HSV 1+2 IgG ELISA Test is comprised of the following items:
- Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8l. well strips with breakaway wells, each well coated with partially purified HSV antigen.
- IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored 2. dilution buffer with sodium azide.
- Conjugate: One bottle containing 15 ml of a pink colored solution of 3. alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
- Substrate Buffer: One bottle containing 30 ml of a blue colored buffer 4. solution with sodium azide.
- p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl న. phosphate (p-NPP).
- Stopping Reagent: One bottle containing 30 ml of a colorless solution of ర్. 1.5 N sodium hydroxide (NaOH).
- Positive Control and Negative Control: One vial of each containing 200 µl 7. of serum (human) with sodium azide.
- Reference Serum: One vial containing 400 µl of serum (human) with 8. sodium azide.
- 20X Wash Solution: One bottle containing 60 ml of a green colored 9. solution with detergent and sodium azide.
- ELISA Plate Sealer: One acetate sheet with contact adhesive. 10.
- Resealable Storage Bag: One plastic sealable bag. 11.
- ELISA Worksheet: One worksheet for recording data. 12.
When the HSV 1+2 IgG ELISA Test is employed, diluted patient serum is incubated with partially purified HSV antigen bound to the ELISA plate wells. If antibodies to herpes simplex virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to herpes simplex virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.
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)
Blood samples from 154 donors were evaluated for the presence of IgG antibody to herpes simplex virus type 1 and type 2 at Gull Laboratories, Inc. with the HSV 1+2 IgG ELISA Test and the HERPELISA II Test Kit. The relative agreement between the two test systems was 96.7% (148/153) with a 95% confidence interval of 92.5% to 98.9%. The relative sensitivity and relative specificity of the HSV 1+2 IgG ELISA Test were 99.1% (112/113) with a 95% confidence interval of 95.2% to 100.0% and 90.0% (36/40) with a 95% confidence interval of 75.3% to 97.2% respectively when compared to the HERPELISA II Test Kit. Equivocal results were not included in the calculations. The calculations for the 95% confidence interval made by the Exact Method.
This serum panel was tested at a hospital in the Northeastern region of the U.S. (Site 1), a clinical laboratory in the Northwestern region of the U.S. (Site 2), and Gull Laboratories, Inc. (Site 3) for IgG antibody to HSV-1 and/or HSV-2 using the HSV 1+2 IgG ELISA Test. All three sites produced the same qualitative results for all but one sample which gave negative results at the hospital in the Northeastern region of the U.S. and the clinical laboratory in the Northwestern region of the U.S. but equivocal results at Gull Laboratories, Inc. The test results were sent to the CDC for analysis and decoding of the specimens.
Based on the CDC's analysis, when the serum panel samples were tested at the hospital laboratory in the Northeastern region of the U.S. and the clinical laboratory in the Northwestern region of the U.S. the HSV 1+2 IgG ELISA Test demonstrated 96.0% (96/100) total agreement with the CDC results at each site. Of the results obtained by the HSV 1+2 IgG ELISA Test, there was 100% agreement for the positive specimens and 85.7% (24/28) agreement for negative specimens.
When the serum samples were tested at Gull Laboratories, Inc. the HSV 1+2 IgG ELISA Test demonstrated 95% (95/100) total agreement with the CDC results. Of the results obtained by the HSV 1+2 IgG ELISA Test, there was 100% (72/72) agreement for the positive specimens and 82.1% (23/28) agreement for negative specimens. One equivocal test result was included in these calculations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative agreement (148/153) 96.7% with a 95% confidence interval of 92.5% to 98.9%.
Relative sensitivity (112/113) 99.1% with a 95% confidence interval of 95.2% to 100.0%.
Relative specificity (36/40) 90.0% with a 95% confidence interval of 75.3% to 97.2%.
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.
HERPELISA II Test Kit
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
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2/26/99
510(k) SUMMARY FOR HSV 1+2 IgG ELISA TEST
SUBMITTER:
Gull Laboratories, Inc. 1011 Murray Holladay Road Salt Lake City, UT 84117 (801) 263-3524
CONTACT PERSON:
Fred W. Rachford
DATE:
December 17, 1998
DEVICE NAME:
| Trade/Proprietary Name: | HSV 1+2 IgG ELISA Test |
|---|---|
| Common/Usual Name: | Anti-HSV IgG Antibody Test |
| Classification Name: | Herpes Simplex Virus Serological Reagent |
HSV 1+2 IgG ELISA Test / Gull Laboratories, Inc. PREDICATE DEVICE:
DEVICE DESCRIPTION:
The HSV 1+2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus (HSV) in human serum by the enzyme-linked immunosorbent assay (ELISA) method.
1
The HSV 1+2 IgG ELISA Test is comprised of the following items:
- Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8l. well strips with breakaway wells, each well coated with partially purified HSV antigen.
- IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored 2. dilution buffer with sodium azide.
- Conjugate: One bottle containing 15 ml of a pink colored solution of 3. alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
- Substrate Buffer: One bottle containing 30 ml of a blue colored buffer 4. solution with sodium azide.
- p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl న. phosphate (p-NPP).
- Stopping Reagent: One bottle containing 30 ml of a colorless solution of ర్. 1.5 N sodium hydroxide (NaOH).
- Positive Control and Negative Control: One vial of each containing 200 µl 7. of serum (human) with sodium azide.
- Reference Serum: One vial containing 400 µl of serum (human) with 8. sodium azide.
- 20X Wash Solution: One bottle containing 60 ml of a green colored 9. solution with detergent and sodium azide.
- ELISA Plate Sealer: One acetate sheet with contact adhesive. 10.
- Resealable Storage Bag: One plastic sealable bag. 11.
- ELISA Worksheet: One worksheet for recording data. 12.
When the HSV 1+2 IgG ELISA Test is employed, diluted patient serum is incubated with partially purified HSV antigen bound to the ELISA plate wells. If antibodies to herpes simplex virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to herpes simplex virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.
2
INTENDED USE:
The HSV-1 Specific IgG ELISA Test is intended for use manually or in conjunction with the DUET™ Instrument in the qualitative detection of IgG antibody to herpes simplex virus type 1 and type 2 in human serum by the enzyme-linked immunosorbent assay (ELISA) method. When performed according to instructions, the HSV 1+2 IgG ELISA Test is of value in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus type 1 and type 2 associated disease.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:
The HSV 1+2 IgG ELISA Test and the HERPELISA II Test kIT both are technologically based on the enzyme-linked immunosorbent assay (ELISA) method.
SUBSTANTIAL EQUIVALENCE PERFORMANCE DATA:
Blood samples from 154 donors were evaluated for the presence of IgG antibody to herpes simplex virus type 1 and type 2 at Gull Laboratories, Inc. with the HSV 1+2 IgG ELISA Test and the HERPELISA II Test Kit. The relative agreement between the two test systems was 96.7% (148/153) with a 95% confidence interval of 92.5% to 98.9%. The relative sensitivity and relative specificity of the HSV 1+2 IgG ELISA Test were 99.1% (112/113) with a 95% confidence interval of 95.2% to 100.0% and 90.0% (36/40) with a 95% confidence interval of 75.3% to 97.2% respectively when compared to the HERPELISA II Test Kit. Equivocal results were not included in the calculations. The calculations for the 95% confidence interval made by the Exact Method.
The following relates to the evaluation of the HSV 1+2 IgG ELISA Test with a serum panel obtained from the Centers for Disease Control (CDC). This serum panel was comprised of one hundred frozen clinical specimens (50 paired sera) which were characterized at the CDC using both an enzyme immunoassay (EIA) and an in-house Western Blot method for HSV type specific antibody detection (9). The serum panel consisted of 72% positive and 28% negative samples. The results of this evaluation are presented below as a means to convey further information regarding the performance of this assay with a masked, characterized serum panel. There should be no other inferences drawn from the panel results presented herein. This does not imply an endorsement of the assay by the CDC.
3
This serum panel was tested at a hospital in the Northeastern region of the U.S. (Site 1), a clinical laboratory in the Northwestern region of the U.S. (Site 2), and (Dito 1), a cincies, Inc. (Site 3) for IgG antibody to HSV-1 and/or HSV-2 using the HSV 1+2 IgG ELISA Test. All three sites produced the same qualitative results for all but one sample which gave negative results at the hospital losure for an-out of the Northeastern region of the U.S. and the clinical laboratory in the Northwestern region of the U.S. but equivocal results at Gull Laboratories, Inc. The test results were sent to the CDC for analysis and decoding of the specimens.
Based on the CDC's analysis, when the serum panel samples were tested at the hospital laboratory in the Northeastern region of the U.S. and the clinical laboratory in the Northwestern region of the U.S. the HSV 1+2 IgG ELISA Test demonstrated 96.0% (96/100) total agreement with the CDC results at each site. Of the results obtained by the HSV 1+2 IgG ELISA Test, there was 100% Or the results country of the positive specimens and 85.7% (24/28) agreement for negative specimens.
When the serum samples were tested at Gull Laboratories, Inc. the HSV 1+2 IgG ELISA Test demonstrated 95% (95/100) total agreement with the CDC results. Of the results obtained by the HSV 1+2 IgG ELISA Test, there was 100% (72/72) agreement for the positive specimens and 82.1% (23/28) agreement for negative specimens. One equivocal test result was included in these calculations.
CONCLUSIONS:
The HSV 1+2 IgG ELISA Test is believed to be substantially equivalent to the HERPELISA II Test Kit. This assessment is based on (1) the two tests are technologically equivalent, both being based on the enzyme-linked immunosorbent assay method, (2) the data from clinical studies conducted at Gull Laboratories, Inc. and two outside clinical institutions demonstrated acceptable agreement and the relative sensitivity and relative specificity when compared with the expected specimen reactivity for patient specimens characterized for IgG antibodies to herpes simplex virus type1 and type 2.
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/4/Picture/3 description: The image shows a stylized black and white drawing of three curved lines that resemble the wing of a bird. The lines are thick and bold, and they are arranged in a slightly overlapping fashion. The overall impression is one of flight or movement.
FEB 2 6 1999
Fred W. Rachford, Ph.D. Senior Vice President Gull Laboratories, Inc. 1011 Murray Holladay Road Salt Lake City, Utah 84117-4999
K983541 Re: Trade Name: HSV 1+2 IgG ELISA Test Regulatory Class: III Product Code: LGC Dated: December 17, 1998 Received: December 22, 1998
Dear Dr. Rachford:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device Onder the Childer Baboutlery infration. To determine if it it des, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. -
This letter will allow you to begin marketing your device as described in your 510(k) rms teter will aron your finding of substantial equivalence of your device to a promation nounced ... - I e device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of and additionally 609.1040. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
EXHIBIT G - REVISED 12/17/98
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ New Submission / Not Assigned
HSV 1+2 IgG ELISA TEST Device Name: __________________
Product Number: H3S100
Indications For Use:
The HSV 1+2 IgG ELISA TEST is to be used manually or in conjunction with the Duet™ instrument in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus associated disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Deebais
(Division Sign/off)
Division of Clinical Laboratory Devices
510(k) Number K98354/
OR
Prescription Use X
(Per 21 CFR 801.109)
Over-The Counter Use
(Optional Format 1-2-96)