K Number

Device Name

PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST

Manufacturer

MERIDIAN DIAGNOSTICS, INC.

Date Cleared

1999-06-25

(203 days)

Product Code

MXJ

Regulation Number

866.3305

Intended Use

The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 1 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-2 IgG ELISA Test in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection. For example, this test can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-1 infection. The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for testing patients with HSV-1 associated meningitis and encephalitis, prenatal and neonatal screening, the testing of immunosuppressed patients, or the detection of early stages of HSV seroconversion.

Device Description

The Premier™ Type Specific HSV-1 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to herpes simplex virus type 1 in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The Premier™ Type Specific HSV-1 IgG ELISA Test is comprised of the following items: - Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-1 glycoprotein G (gG-1). - IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide. - Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide. - Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide. - p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP). - Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH). - Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide. - Reference Serum: One vial containing 400 ul of serum (human) with sodium azide. - 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide. - ELISA Plate Sealer: One acetate sheet with contact adhesive. - Resealable Storage Bag: One plastic sealable bag. - ELISA Worksheet: One worksheet for recording data. When the Premier™ Type Specific HSV-1 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 1 glycoprotein (gG1) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 1 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 the herpes simplex virus type 1 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

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Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard ELISA assay kit and its components, with no mention of software, algorithms, or computational analysis beyond reading a color endpoint with a standard ELISA plate reader. The performance studies focus on traditional metrics like sensitivity and specificity compared to a predicate device and Western Blot, without any indication of AI/ML model training or evaluation.

Therapeutic

No.
This device is an in vitro diagnostic test for detecting antibodies to HSV-1, which is used for diagnostic purposes, not for treating or preventing disease.

Diagnostic

Yes

Explanation: The device description explicitly states, "The Premier™ Type Specific HSV-1 IgG ELISA Test is an in vitro diagnostic medical device." Additionally, the "Intended Use / Indications for Use" section details its purpose in detecting IgG antibodies to herpes simplex virus type 1 in human serum, which is a diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly lists multiple physical components (ELISA plate, reagents, controls, etc.) that are essential for the device's function. It is an in vitro diagnostic kit, not a software-only device.

IVD (In Vitro Diagnostic)

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

The "Device Description" explicitly states: "The Premier™ Type Specific HSV-1 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to herpes simplex virus type 1 in human serum by the enzyme-linked immunosorbent assay (ELISA) method."

Furthermore, the "Intended Use / Indications for Use" describes testing human serum specimens, which is a biological sample taken from the body, and the test is performed outside of the body ("in vitro"). The purpose is to diagnose or aid in the diagnosis of a condition (presence of IgG antibody to herpes simplex virus type 1).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Premier™ Type Specific HSV-1 IgG ELISA Test is intended for the qualitative detection of IgG antibody to the herpes simplex virus type 1 in human serum by the enzyme-linked immunosorbent assay (ELISA) method. When performed according to instructions, the Premier™ Type Specific HSV-1 IgG ELISA Test is of value when used in conjunction with the Premier™ Type Specific HSV-2 IgG ELISA Test in screening sexually active adults and in the determination of infection with HSV-1. It also is of use in conducting epidemiological studies pertaining to HSV-1 infection.

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

MXJ

Device Description

The Premier™ Type Specific HSV-1 IgG ELISA Test is comprised of the following items:

Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-1 glycoprotein G (gG-1).
IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide.
Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide.
p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP).
Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH).
Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide.
Reference Serum: One vial containing 400 ul of serum (human) with sodium azide.
20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide.
ELISA Plate Sealer: One acetate sheet with contact adhesive.
Resealable Storage Bag: One plastic sealable bag.
ELISA Worksheet: One worksheet for recording data.

When the Premier™ Type Specific HSV-1 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 1 glycoprotein (gG1) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 1 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 the herpes simplex virus type 1 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

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

The Premier™ Type Specific HSV-1 IgG ELISA Test is not recommended for use in a pediatric population.

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)

Study Type: Substantial Equivalence Performance Data (Clinical Laboratory in Pacific Northwest Region of US)
Sample Size: 193 frozen samples of sequential sera (180 included in relative agreement calculations)
Key Results:

Relative agreement between Premier™ Type Specific HSV-1 IgG ELISA Test and Western Blot Method: 95.0% (171/180) with a 95% confidence interval of 90.7% to 97.7%.
Relative sensitivity of Premier™ Type Specific HSV-1 IgG ELISA Test compared to Western Blot: 93.8% (91/97) with a 95% confidence interval of 87.0% to 97.7%.
Relative specificity of Premier™ Type Specific HSV-1 IgG ELISA Test compared to Western Blot: 96.4% (80/83) with a 95% confidence interval of 89.8% to 99.2%.

Study Type: CDC Serum Panel Testing
Sample Size: 100 clinical specimens (50 paired sera)
Data Source: Centers for Disease Control (CDC)
Key Results:

93.0% total agreement with the CDC results (characterized previously by CDC EIA and Western Blot testing).
93.1% agreement with anti-HSV-1 positive specimens.
92.9% agreement with anti-HSV-1 negative specimens.

Study Type: Archived Serum Samples (Patients with culture documented HSV-1 infection)
Sample Size: 49 archived serum samples
Key Results:

75.8% (37/49) of the serum samples from culture positive patients tested positive in the Premier™ Type Specific HSV-1 IgG ELISA Test (based on repeat testing of equivocal samples).
The assay's positive and negative predictive values could not be calculated or inferred due to pre-selected retrospective specimens.

Study Type: Prospective Collection from STD Clinics (Pacific Northwest Region of US)
Sample Size: 756 serum samples from unduplicated individuals
Key Results:

Relative agreement between Premier™ Type Specific HSV-1 IgG ELISA Test and Western Blot Method: 93.4% (706/756).
Relative sensitivity of Premier™ Type Specific HSV-1 IgG ELISA Test compared to Western Blot: 91.0% (384/422) with a 95% confidence interval of 87.7%-93.5%.
Relative specificity of Premier™ Type Specific HSV-1 IgG ELISA Test compared to Western Blot: 96.4% (322/334) with a 95% confidence interval of 93.6%-98.0%.

Study Type: Low Prevalence Populations (Specificity Study)
Sample Size:

199 pediatric patients (one to twelve years of age, Northeast Region of US)
209 individuals (University Student Health Clinic, Pacific Northwest Region of US)
100 Blood Bank donors (Northeast Region of US)
Key Results for Pediatric Patients:
Relative agreement: 86.2% (169/196) with a 95% confidence interval of 80.6%-90.7%.
Relative sensitivity: 100.0% (38/38) with a 95% confidence interval of 90.7%-100.0%.
Relative specificity: 82.9% (131/158) with a 95% confidence interval of 76.1%-88.4%.
Key Results for University Student Health Clinic Specimens:
Relative agreement: 93.7% (193/206) with a 95% confidence interval of 89.5%-96.9%.
Relative sensitivity: 79.7% (47/59) with a 95% confidence interval of 67.2%-89.0%.
Relative specificity: 99.3% (146/147) with a 95% confidence interval of 96.3%-100.0%.
Key Results for Blood Bank Specimens:
Relative agreement: 95.0% (95/100) with a 95% confidence interval of 88.7%-98.3%.
Relative sensitivity: 93.4% (71/76) with a 95% confidence interval of 85.3%-97.8%.
Relative specificity: 100.0% (24/24) with a 95% confidence interval of 85.8%-100.0%.

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

From Clinical Laboratory Study:

Relative sensitivity: 93.8% (91/97) with a 95% confidence interval of 87.0% to 97.7%.
Relative specificity: 96.4% (80/83) with a 95% confidence interval of 89.8% to 99.2%.

From STD Clinics Study:

Relative sensitivity: 91.0% (384/422) with a 95% confidence interval of 87.7%-93.5%.
Relative specificity: 96.4% (322/334) with a 95% confidence interval of 93.6%-98.0%.
Predictive value positive: 97.0% (384/396) with a 95% confidence interval of 94.6%-98.4%.
Predictive value negative: 89.4% (322/360) and a 95% confidence interval of 85.7%-92.3%.

From Pediatric Patients Study (low prevalence):

Relative sensitivity: 100.0% (38/38) with a 95% confidence interval of 90.7%-100.0%.
Relative specificity: 82.9% (131/158) with a 95% confidence interval of 76.1%-88.4%.
Predictive value positive: 58.5% (38/65) with a 95% confidence interval of 45.6%-70.6%.
Predictive value negative: 100.0% (131/131) and a 95% confidence interval of 97.2%-100.0%.

From University Student Health Clinic Specimens Study (low prevalence):

Relative sensitivity: 79.7% (47/59) with a 95% confidence interval of 67.2%-89.0%.
Relative specificity: 99.3% (146/147) with a 95% confidence interval of 96.3%-100.0%.
Predictive value positive: 97.9% (47/48) with a 95% confidence interval of 88.9%-99.9%.
Predictive value negative: 92.4% (146/158) and a 95% confidence interval of 87.1%-96.0%.

From Blood Bank Specimens Study (low prevalence):

Relative sensitivity: 93.4% (71/76) with a 95% confidence interval of 85.3%-97.8%.
Relative specificity: 100.0% (24/24) with a 95% confidence interval of 85.8%-100.0%.
Predictive value positive: 100.0% (71/71) with a 95% confidence interval of 94.9%-100.0%.
Predictive value negative: 82.2% (24/29) with a 95% confidence interval of 64.2%-94.1%.

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.

HSV-1 IgG ELISA 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

§ 866.3305 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).

Summary

JUN 25 1999

484343

510(k) SUMMARY FOR PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST

Gull Laboratories, Inc. SUBMITTER: 1011 Murray Holladay Road Salt Lake City, UT 84117 (801) 263-3524

Fred W. Rachford CONTACT PERSON:

DATE: June 22, 1999

DEVICE NAME:

| Trade/Proprietary Name: | PremierTM Type Specific
HSV-1 IgG ELISA Test |
|-------------------------|----------------------------------------------------|
| Common/Usual Name: | Anti-HSV-1 IgG Antibody Test |
| Classification Name: | Herpes Simplex Virus Type 1 Serological
Reagent |

HSV-1 IgG ELISA Test / Gull Laboratories, Inc. PREDICATE DEVICE:

DEVICE DESCRIPTION:

The Premier™ Type Specific HSV-1 IgG ELISA Test is comprised of the following items:

Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-1.

well strips with breakaway wells, each well coated with affinity purified HSV-1 glycoprotein G (gG-1).

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 6. 1.5 N sodium hydroxide (NaOH).
Positive Control and Negative Control: One vial of each containing 200 ul 7. of serum (human) with sodium azide.
Reference Serum: One vial containing 400 ul of serum (human) with 8. sodium azide.
1. 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide.
1. ELISA Plate Sealer: One acetate sheet with contact adhesive.
1. Resealable Storage Bag: One plastic sealable bag.
1. ELISA Worksheet: One worksheet for recording data.

INTENDED USE:

The Premier™ Type Specific HSV-1 IgG ELISA Test is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for testing patients with HSV associated meningitis and encephalitis, prenatal and neonatal screening, the testing of immunosuppressed patients, or the detection of early stages of HSV seroconversion.

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:

The Premier™ Type Specific HSV-1 IgG ELISA Test and the HSV-1 IgG ELISA Test both are technologically based on the enzyme-linked immunosorbent assay (ELISA) method.

SUBSTANTIAL EQUIVALENCE PERFORMANCE DATA:

Frozen samples of sequential sera from 193 patients were submitted to a clinical laboratory in the Pacific Northwest Region of the US for HSV antibody detection and typing. These specimens were tested for IgG antibodies to HSV-1 using the Premier™ Type Specific HSV-1 IgG ELISA Test and a Western Blot Method for detection of HSV type specific antibody. The relative agreement between the two test systems was 95.0% (171/180) with a 95% confidence interval of 90.7% to 97.7%. The relative sensitivity and relative specificity of the Premier™ Type Specific HSV-1 IgG ELISA Test were 93.8% (91/97) with a 95% confidence interval of 87.0% to 97.7% and 96.4% (80/83) with a 95% confidence interval of 89.8% to 99.2% respectively when compared with the Western Blot results. There were nine specimens which demonstrated either equivocal ELISA results or atypical Western Blot results and four specimens that could not be typed by Western Blot which were not included in the above calculations. The calculations for the 95% confidence interval were made by the Exact Method.

The following information is from a serum panel obtained from the Centers for Disease Control (CDC) and tested by Gull Laboratories, Inc. 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.

A serum panel comprised of one hundred clinical specimens (50 paired sera) was tested using the Premier™ Type Specific HSV-1 IgG ELISA Test. These specimens were characterized previously by CDC EIA and Western Blot testing. The panel of 100 samples contains more than 40% positive anti-HSV-1 samples. The Premier™ Type Specific HSV-1 IgG ELISA Test demonstrated 93.0% total agreement with the CDC results. Of the results obtained with the Premier™ Type Specific HSV-1 IgG ELISA Test there was 93.1% agreement with the anti-HSV-1 positive specimens and 92.9% agreement with the anti-HSV-1 negative specimens.

Forty nine archived serum samples from patients with culture documented HSV-1 infection were tested with the Premier™ Type Specific HSV-1 IgG ELISA Test. Based on repeat testing of equivocal samples 75.8% (37/49) of the serum samples from culture positive patients tested positive in the Premier™ Type Specific HSV-1 IgG ELISA Test. Since the above study was performed on pre-selected retrospective specimens, the assay's positive and negative predictive values could not be calculated or inferred.

Seven hundred fifty six serum samples prospectively collected from unduplicated individuals attending two STD Clinics in the Pacific Northwest Region of the US were tested with the Premier™ Type Specific HSV-1 IgG ELISA Test and a Western Blot Method for type specific IgG antibody to HSV-1. Western Blot results were based on initial testing with the exception of specimens with initial atypical results which were reanalyzed. These repeat Western Blot results were used for patients returning for repeat analysis. Patients not returning for repeat testing were presumed to be negative. Specimens initially reported as equivocal with the Premier™ Type Specific HSV-1 IgG ELISA Test were retested with the second test result used. The relative agreement between the two methods was 93.4% (706/756). The relative sensitivity and relative specificity of the Premier™ Type Specific HSV-1 IgG ELISA Test were 91.0% (384/422) with a 95% confidence interval of 87.7%-93.5% and 96.4% (322/334) with a 95% confidence interval of 93.6%-98.0% respectively when compared with the Western Blot results. The predictive value positive and predictive value negative were 97.0% (384/396) with a 95% confidence interval of 94.6%-98.4% and 89.4% (322/360) and a 95% confidence interval of 85.7%-92.3% respectively.

The Premier™ Type Specific HSV-1 IgG ELISA Test also was used to test serum samples from individuals in low prevalence populations to determine the specificity of the assay. Serum samples from (a) one hundred ninety nine pediatric patients, one to twelve years of age, in the Northeast Region of the US, (b) two hundred nine individuals attending a University Student Health Clinic in the Pacific Northwest Region of the US, and (c) one hundred Blood Bank donors in the Northeast Region of the US were tested with the Premier™ Type Specific HSV-1 IgG ELISA Test and a Western Blot Method for type specific IgG antibody to HSV-1. Western Blot results were based on initial testing with the exception of specimens with initial atypical results which were reanalyzed. These repeat Western Blot results were used for analysis. Specimens initially reported as

equivocal with the Premier™ Type Specific HSV-1 IgG ELISA Test were retested with the second test result used.

For the pediatric patient specimens the relative agreement between the two methods was 86.2% (169/196) with a 95% confidence interval of 80.6%-90.7%. The relative sensitivity and relative specificity of the Premier™ Type Specific HSV-1 IgG ELISA Test were 100.0% (38/38) with a 95% confidence interval of 90.7%-100.0% and 82.9% (131/158) with a 95% confidence interval of 76.1%-88.4% respectively when compared to the Western Blot results. The predictive value positive and predictive value negative were 58.5% (38/65) with a 95% confidence interval of 45.6%-70.6% and 100.0% (131/131) and a 95% confidence interval of 97.2%-100.0% respectively. There were three specimens which demonstrated equivocal ELISA results which were not included in the calculations.

For the University Student Health Clinic specimens the relative agreement between the two methods was 93.7% (193/206) with a 95% confidence interval of 89.5%-96.9%. The relative sensitivity and relative specificity of the Premier™ Type Specific HSV-1 IgG ELISA Test were 79.7% (47/59) with a 95% confidence interval of 67.2%-89.0% and 99.3% (146/147) with a 95% confidence interval of 96.3%-100.0% respectively when compared to the Western Blot results. The predictive value positive and predictive value negative were 97.9% (47/48) with a 95% confidence interval of 88.9%-99.9% and 92.4% (146/158) and a 95% confidence interval of 87.1%-96.0% respectively. There were three specimens which demonstrated equivocal ELISA results which were not included in the calculations.

For the Blood Bank specimens the relative agreement between the two methods was 95.0% (95/100) with a 95% confidence interval of 88.7%-98.3%. The relative sensitivity and relative specificity of the Premier™ Type Specific HSV-1 IgG ELISA Test were 93.4% (71/76) with a 95% confidence interval of 85.3%-97.8% and 100.0% (24/24) with a 95% confidence interval of 85.8%-100.0% respectively when compared with the Western Blot results. The predictive value positive and predictive value negative were 100.0% (71/71) with a 95% confidence interval of 94.9%-100.0% and 82.2% (24/29) with a 95% confidence interval of 64.2%-94.1% respectively.

CONCLUSIONS:

The Premier™ Type Specific HSV-1 IgG ELISA Test is believed to be substantially equivalent to the HSV-1 IgG ELISA Test. This assessment is based on (1) the two tests are technologically equivalent, both being based on the enzyme-linked immunosorbent assay methods, (2) the intended use of each test is comparable with both being used for the qualitative determination of antibody to HSV-1 with the HSV-1 Specific IgG ELISA Test having improved specificity, and (3) 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 test results were compared with the expected specimen reactivity showed the HSV-1 Type Specific IgG ELISA Test to demonstrate superior specificity for IgG antibody to HSV-1.

Image /page/6/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Alan Nickol, Ph.D. Director of Clinical and Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244

Re: K984343

Trade Name: Premier™ Type Specific HSV-1 IgG ELISA Test Regulatory Class: III Product Code: MXJ Dated: April 7, 1999 Received: April 8, 1999

Dear Dr. Nickol:

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 OS 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.

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 Compliance at (301) 594-4588. 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 Sutman

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

EXHIBIT F - REVISED 06/22/99

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K984343

PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST Device Name:

Product Number:

Indications For Use:

The PREMIER™ TYPE SPECIFIC HSV-1 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for testing patients with HSV-1 associated meningitis and encephalitis, prenatal and neonatal screening, the testing of immunosuppressed patients, or the detection of early stages of HSV seroconversion.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Woody Dubais
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number	K984343