(96 days)
HSV-1 ELISA Test System, HSV-1 Western Blot, HSV-1 Culture
Not Found
No
The device description outlines a standard ELISA assay with spectrophotometric reading and comparison to reference cut-off values. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on traditional analytical and clinical performance metrics.
No.
A therapeutic device is one that treats a disease or condition. This device is for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 to aid in diagnosis and counseling, not for treatment.
Yes
The device is described as an "HSV-1 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera." It aids in the "presumptive diagnosis of HSV infection" and "presumptive assessment of the risk for acquiring and/or transmitting HSV". These functions clearly fit the definition of a diagnostic device.
No
The device description clearly outlines a laboratory-based ELISA assay which involves physical components like microwells, reagents, and a spectrophotometer for optical density readings. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera." This involves testing human specimens (sera) in vitro (outside the body) to provide information about a person's health status (presence of HSV-1 antibodies).
- Device Description: The description details a laboratory procedure (ELISA) performed on serum samples. This is a classic in vitro diagnostic method.
- Performance Studies: The performance studies involve testing the device's ability to accurately detect antibodies in human serum samples and comparing the results to other diagnostic methods (Western blot, culture). This is characteristic of the validation required for IVD devices.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MRL Diagnostics' HSV-1 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the MRL HSV-2 ELISA IgG, the test is indicated for 1) testing sexually active adults, with or without a clinical history of herpes, for aiding in the presumptive diagnosis of HSV infection to identify persons who are at risk for transmitting or acquiring HSV so they may be counseled, and 2) testing expectant mothers for aiding in the presumptive assessment of the risk for acquiring and/or transmitting HSV to their child, so they may be counseled.
Product codes
MXJ
Device Description
In the MRL Diagnostics HSV-1 ELISA IgG assay, the polystyrene microwells are coated Device with recombinant gG-1 antigen. Diluted serum samples and controls are incubated in the wells to allow specific antibody present in the samples to react with the antigen. Nonspecific reactants are removed by washing, and peroxidase-conjugated anti-human IgG is added and reacts with specific IgG. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD) which is directly proportional to the amount of antigen specific IgG present in the sample. Sample optical density readings are compared with reference cut-off OD readings to determine results.
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
Adults over the age of 14, Expectant mothers.
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
An outside investigator assessed the device with masked, archived and unselected sera Expected from 1) sexually active adults over the age of 14 (n = 246), and 2) from expectant mothers (n = 241). Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States.
An outside investigator assessed the device's sensitivity and specificity with masked, archived and unselected sera from expectant mothers (n = 241). Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States.
An outside investigator assessed the device's sensitivity and specificity with masked, archived and unselected sera from sexually active adults over the age of 14 (n = 246). Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States.
An outside investigator assessed the device's sensitivity using sera from culture positive patients (n = 38). Disease state was defined using culture positivity and a type specific Culture Western blot from a major university located in the Northwestern United States.
An internal investigator evaluated the CDC's HSV/CMV serum panel (n = 99).
An outside investigator assessed the device's specificity using sera from a low prevalence population of college students. Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States.
An outside investigator assessed the device's type specificity using HSV-1 Western blot negative and HSV-2 Western blot positive sera from the above described populations (n = 90): expectant mothers, sexually active adults, low prevalence persons, and HSV-1 culture positives. Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States.
MRL assessed the device's cross-reactivity using sera (n=26) from 1) HSV sero-negative by another manufacturer's FDA cleared HSV ELISAs, and 2) IFA IgG positive for taxonomically similar viruses including CMV, EBV VCA, HHV6 and VZV. Discrepants between the FDA cleared HSV ELISAs and the MRL device were analyzed using a type specific Western blot from a major university located in the Northwestern United States.
MRL assessed the device's intra-assay and inter-assay reproducibility using a slightly modified version of "Evaluation of Precision Performance of Clinical Chemistry Devices", NCCLS Document EP5-T2 (March 1992). Briefly, seven samples were run in duplicate, twice a day, for twenty days, for a total of forty runs, for a total of forty data points for each sample.
An internal investigator assessed the device's inter-lot reproducibility. Five samples were run on three separate days with three separate lots. For one lot, the samples were run in triplicate, and run in duplicate with the other two lots.
An internal investigator and two off site laboratories assessed the device's inter-laboratory reproducibility. Each of the three laboratories ran seven samples in triplicate on three different days.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Expected vs Observed Prevalence with Sexually Active Adults & Expectant Mothers: An outside investigator assessed the device with masked, archived and unselected sera from 1) sexually active adults over the age of 14 (n = 246), and 2) from expectant mothers (n = 241). Serological "truth" was defined using a type specific Western blot.
Predictive Values vs Prevalence with Sexually Active Adults & Expectant Mothers: The MRL HSV-1 ELISA IgG had 91.2% sensitivity & 92.3% specificity with sexually active adults, and 96.0% sensitivity & 95.2% specificity with expectant mothers.
Sensitivity, Specificity & Predictive Values with Expectant Mothers: An outside investigator assessed the device's sensitivity and specificity with masked, archived and unselected sera from expectant mothers (n = 241). Results: Sensitivity 96.0% (170/177), Specificity 95.2% (59/62), Pos Predictive Value 98.3% (170/173), Neg Predictive Value 88.9% (59/69).
Sensitivity, Specificity & Predictive Values with Sexually Active Adults: An outside investigator assessed the device's sensitivity and specificity with masked, archived and unselected sera from sexually active adults over the age of 14 (n = 246). Results: Sensitivity 91.2% (125/137), Specificity 92.3% (96/104), Pos Predictive Value 94.0% (125/133), Neg Predictive Value 88.9% (96/108).
Sensitivity with Culture Positives: An outside investigator assessed the device's sensitivity using sera from culture positive patients (n = 38). Results: MRL EL vs. Culture 78.9% (30/38), MRL EL vs. WB 81.1% (30/37).
Evaluation of CDC's HSV/CMV Panel: An internal investigator evaluated the CDC's HSV/CMV serum panel (n = 99). Results for CDC HSV-1 positive: MRL ELISA positive 93.1% (54/58), MRL ELISA negative 100% (13/13). Results for CDC HSV-1 negative: MRL ELISA negative 100% (28/28).
Specificity with a Low Prevalence Population: An outside investigator assessed the device's specificity using sera from a low prevalence population of college students. Results: WB-1 neg MRL ELISA neg 98.2% (55/56), WB-1 + MRL ELISA + 75.0% (18/24).
Type Specificity with HSV-2 Western Blot Positives: An outside investigator assessed the device's type specificity using HSV-1 Western blot negative and HSV-2 Western blot positive sera (n = 90). Results: WB-1 neg WB-2 + MRL EL neg 91.1% (82/90), WB-1 neg WB-2 + MRL EL + 8.9% (8/90).
Cross-reactivity with Taxonomically Related Viruses: MRL assessed the device's cross-reactivity using sera (n=26) from HSV sero-negative by other FDA cleared HSV ELISAs and IFA IgG positive for CMV, EBV VCA, HHV6, and VZV. Results: CMV 100% (12/12), EBV VCA 100% (24/24), HHV6 100% (24/24), VZV 100% (23/23). Total 100% (83/83).
Intra-assay & Inter-assay Reproducibility: Intra-assay and inter-assay reproducibility studies were performed using seven samples run in duplicate, twice a day, for twenty days (total 40 runs). Sample 11 and 16 are masked duplicates, Sample 12 and 17 are masked duplicates.
Sample 11: Index Mean 0.10, Intra-assay % CV 40.0%, Inter-assay % CV 50.4%.
Sample 16: Index Mean 0.10, Intra-assay % CV 0.0%, Inter-assay % CV 11.6%.
Sample 12: Index Mean 1.58, Intra-assay % CV 3.8%, Inter-assay % CV 7.0%.
Sample 17: Index Mean 1.55, Intra-assay % CV 40.0%, Inter-assay % CV 5.4%.
Sample 13: Index Mean 2.67, Intra-assay % CV 3.6%, Inter-assay % CV 4.9%.
Sample 14: Index Mean 3.08, Intra-assay % CV 3.9%, Inter-assay % CV 6.5%.
Sample 15: Index Mean 11.96, Intra-assay % CV 2.2%, Inter-assay % CV 5.6%.
Inter-lot Reproducibility: Five samples were run on three separate days with three separate lots.
Sample 11: Index Mean 0.09, % CV 26.8%.
Sample 16: Index Mean 0.09, % CV 20.2%.
Sample 12: Index Mean 1.47, % CV 8.2%.
Sample 17: Index Mean 1.41, % CV 2.9%.
Sample 13: Index Mean 2.48, % CV 11.1%.
Sample 14: Index Mean 2.64, % CV 9.4%.
Sample 15: Index Mean 10.85, % CV 25.1%.
Inter-laboratory Reproducibility: Three laboratories ran seven samples in triplicate on three different days.
Sample 11: Mean Index 0.15, %CV of Lab Means 6.6%, Mean of Lab %CVs 70.9%.
Sample 16: Mean Index 0.15, %CV of Lab Means 23.6%, Mean of Lab %CVs 63.1%.
Sample 12: Mean Index 1.44, %CV of Lab Means 13.5%, Mean of Lab %CVs 7.0%.
Sample 17: Mean Index 1.48, %CV of Lab Means 13.0%, Mean of Lab %CVs 4.3%.
Sample 13: Mean Index 2.37, %CV of Lab Means 10.8%, Mean of Lab %CVs 5.7%.
Sample 14: Mean Index 2.72, %CV of Lab Means 10.7%, Mean of Lab %CVs 7.5%.
Sample 15: Mean Index 14.24, %CV of Lab Means 24.3%, Mean of Lab %CVs 64.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), % CV (Coefficient of Variation).
Predicate Device(s)
HSV-1 ELISA Test System, Zeus Scientific, Inc., HSV-1 Western Blot, University of Washington, HSV-1 Culture, University of Washington
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
9 2000 FEB
MRL DIAGNOSTICS
993754
510(k) Summary of Safety and Effectiveness (Page 1 of 6)
| Applicant: | MRL Diagnostics
a Focus/MRL Inc. Company
10703 Progress Way
Cypress, California 90630 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration No: | 2023365 |
| Contact Person: | Michael J. Wagner, Esq. |
| Phone: | (714) 220-1900 |
| Telefax: | (714) 220-1182 |
| E-mail: | mwagner@mrlinfo.com |
| Summary Date: | October 31, 1999 |
| Device Name: | HSV-1 ELISA IgG |
| Classification: | Herpes Simplex Virus Serological Reagents
21 CFR §866.3305
Class III |
| Predicate
Device: | 1) HSV-1 ELISA Test System, Zeus Scientific, Inc.
2) HSV-1 Western Blot, University of Washington
3) HSV-1 Culture, University of Washington |
1
510(k) Summary of Safety and Effectiveness (Page 2 of 6)
- In the MRL Diagnostics HSV-1 ELISA IgG assay, the polystyrene microwells are coated Device with recombinant gG-1 antigen. Diluted serum samples and controls are incubated in the Description: wells to allow specific antibody present in the samples to react with the antigen. Nonspecific reactants are removed by washing, and peroxidase-conjugated anti-human IgG is added and reacts with specific IgG. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD) which is directly proportional to the amount of antigenspecific IgG present in the sample. Sample optical density readings are compared with reference cut-off OD readings to determine results.
- MRL Diagnostics' HSV-1 ELISA IgG test is intended for qualitatively detecting the Intended Use: presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the MRL HSV-2 ELISA IgG, the test is indicated for 1) testing sexually active adults, with or without a clinical history of herpes, for aiding in the presumptive diagnosis of HSV infection to identify persons who are at risk for transmitting or acquiring HSV so they may be counseled, and 2) testing expectant mothers for aiding in the presumptive assessment of the risk for acquiring and/or transmitting HSV to their child, so they may be counseled.
2
510(k) Summary of Safety and Effectiveness (Page 3 of 6)
An outside investigator assessed the device with masked, archived and unselected sera Expected from 1) sexually active adults over the age of 14 (n = 246), and 2) from expectant mothers Values: (n = 241). Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States. Excluding four atypical Western blots and three ELISA equivocals, the observed vs expected prevalences and the positive predictive values (PPV) and negative predictive values (NPV) for the two populations are as follows:
| Population | HSV-1
Sero-status | Expected Prevalence | | Observed Prevalence | |
|-------------------------------|----------------------|---------------------|------------|---------------------|--------------|
| | | % | 95% CI | WB | MRL
ELISA |
| Sexually
Active
Adults* | neg | 59.0% | 56.3-61.8% | 55.7% | 54.1% |
| | + | 41.0% | 38.2-43.7% | 42.3% | 43.9% |
| Expectant
Mothers** | neg | 65.2% | 64.2-66.2% | 71.0% | 71.8% |
| | + | 34.8% | 33.8-35.8% | 28.6% | 24.5% |
Expected vs Observed Prevalence with Sexually Active Adults & Expectant Mothers
- Approximate prevalences for sexually active adult population estimated from unpublished values received from investigator at a major university in the Northwestern United States.
** Approximate prevalences for expected mother population estimated from published values.
Predictive Values vs Prevalence with Sexually Active Adults & Expectant Mothers
| Pos
Prev | Neg
Prev | Sexually Active Adults* | | | | Expectant Mothers** | | | |
|-------------|-------------|-------------------------|--------------|-------|--------------|---------------------|--------------|-------|--------------|
| | | PPV | PPV
95%CI | NPV | NPV
95%CI | PPV | PPV
95%CI | NPV | NPV
95%CI |
| 90% | 10% | 99.1% | 98.1-99.6% | 57.1% | 39.4-75.9% | 99.4% | 98.4-99.9% | 68.8% | 41.6-91.7% |
| 80% | 20% | 97.9% | 95.9-99.1% | 75.0% | 59.4-87.7% | 98.8% | 96.5-99.7% | 83.2% | 61.6-96.1% |
| 70% | 30% | 96.5% | 93.2-98.5% | 83.7% | 71.5-92.4% | 97.9% | 94.1-99.6% | 89.5% | 73.3-97.7% |
| 60% | 40% | 94.7% | 89.7-97.7% | 88.9% | 79.6-95.0% | 96.8% | 91.1-99.3% | 93.0% | 81.0-98.5% |
| 50% | 50% | 92.2% | 85.4-96.6% | 92.3% | 85.4-96.6% | 95.2% | 87.2-99.0% | 95.2% | 86.5-99.0% |
| 40% | 60% | 88.8% | 79.6-94.9% | 94.7% | 89.8-97.7% | 93.0% | 82.0-98.5% | 96.7% | 90.6-99.3% |
| 30% | 70% | 83.5% | 71.4-92.3% | 96.5% | 93.2-98.5% | 89.6% | 74.5-97.7% | 97.9% | 93.7-99.6% |
| 20% | 80% | 74.8% | 59.3-87.5% | 98.0% | 95.9-99.1% | 83.3% | 63.0-96.1% | 98.8% | 96.2-99.7% |
| 10% | 90% | 56.8% | 39.3-75.7% | 99.1% | 98.1-99.6% | 69.0% | 43.1-91.6% | 99.4% | 98.3-99.9% |
- MRL HSV-1 ELISA IgG having 91.2% sensitivity & 92.3% specificity with sexually active adults. ** MRL HSV-1 ELISA IgG having 96.0% sensitivity & 95.2% specificity with expectant mothers.
3
510(k) Summary of Safety and Effectiveness (Page 4 of 6)
An outside investigator assessed the device's sensitivity and specificity with masked, Sensitivity and archived and unselected sera from expectant mothers (n = 241). Serological "truth" was Specificity with defined using a type specific Western blot from a major university located in the Expectant Northwestern United States. Excluding one atypical Western blots and one ELISA Mothers equivocal, the results are:
| Attribute | % | Ratio (n/N) | 95% CI |
|---|---|---|---|
| Sensitivity | 96.0% | 170/177 | 92.0-98.4% |
| Specificity | 95.2% | 59/62 | 86.5-99.0% |
| Pos Predictive Value | 98.3% | 170/173 | 95.0-99.6% |
| Neg Predictive Value | 88.9% | 59/69 | 75.0-92.8% |
Sensitivity, Specificity & Predictive Values with Expectant Mothers
Sensitivity. Specificity & Predictive Values with Sexually Active Adults
CDC's
Panel
An outside investigator assessed the device's sensitivity and specificity with masked, archived and unselected sera from sexually active adults over the age of 14 (n = 246). Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States. Excluding three atypical Western blots and two ELISA equivocal, the results are:
Sensitivity, Specificity & Predictive Values with Sexually Active Adults
| Attribute | % | Ratio (n/N) | 95% CI | |
|---|---|---|---|---|
| Sensitivity | 91.2% | 125/137 | 85.2-95.4% | |
| Specificity | 92.3% | 96/104 | 85.4-96.6% | |
| Pos Predictive Value | 94.0% | 125/133 | 88.5-97.4% | |
| Neg Predictive Value | 88.9% | 96/108 | 81.4-94.1% |
Sensitivity with An outside investigator assessed the device's sensitivity using sera from culture positive patients (n = 38). Disease state was defined using culture positivity and a type specific Culture Western blot from a major university located in the Northwestern United States. The Positives results are:
| Comparison | % | Ratio (n/N) | 95% CI |
|---|---|---|---|
| MRL EL vs. Culture | 78.9% | 30/38 | 62.7-90.4% |
| MRL EL vs. WB | 81.1% | 30/37 | 64.8-92.0% |
An internal investigator evaluated the CDC's HSV/CMV serum panel (n = 99). The CDC Evaluation of panel results are presented as a means to convey further information on the performance HSV/CMV of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC. The results of the CDC panel evaluation were:
| Interpretation | | | % | Ratio
(n/N) | 95% CI |
|----------------|--------------|--------------|-------|----------------|------------|
| CDC
HSV-1 | CDC
HSV-1 | MRL
ELISA | | | |
| + | + or neg | + | 93.1% | 54/58 | 83.3-98.1% |
| + | neg | neg | 100% | 13/13 | 75.3-100% |
| neg | neg | neg | 100% | 28/28 | 87.7-100% |
Evaluation of CDC's HSV/CMV Panel
714 220-1900 FAX • 714 220-1182
4
MRL DIAGNOSTICS
510/k) Summary of Safety and Effectiveness (Page 5 of 6)
An outside investigator assessed the device's specificity using sera from a low prevalence Specificity with population of college students. Serological "truth" was defined using a type specific a Low Western blot from a major university located in the Northwestern United States. Prevalence Population Excluding one ELISA equivocal, the results are:
| Interpretation | | % | Ratio
(n/N) | 95% CI |
|----------------|-----------|-------|----------------|------------|
| WB-1 | MRL ELISA | | | |
| neg | neg | 98.2% | 55/56 | 90.5-100% |
| + | + | 75.0% | 18/24 | 53.3-90.2% |
Specificity with a Low Prevalence Population
Type Specificity with HSV-2 Western Blot Positives
An outside investigator assessed the device's type specificity using HSV-1 Western blot negative and HSV-2 Western blot positive sera from the above described populations (n = 90): expectant mothers, sexually active adults, low prevalence persons, and HSV-1 culture positives. Serological "truth" was defined using a type specific Western blot from a major university located in the Northwestern United States. The results are:
| Type Specificity with HSV-2 Western Blot Positives | ||
|---|---|---|
| Group | % | Ratio (n/N) | 95% CI | ||
|---|---|---|---|---|---|
| WB-1 | WB-2 | MRL EL | |||
| neg | + | neg | 91.1% | 82/90 | 83.2-96.1% |
| neg | + | + | 8.9% | 8/90 | 3.9-16.8% |
Cross-reactivity with Taxonomically Related Viruses
MRL assessed the device's cross-reactivity using sera (n=26) from 1) HSV sero-negative by another manufacturer's FDA cleared HSV ELISAs, and 2) IFA IgG positive for taxonomically similar viruses including CMV, EBV VCA, HHV6 and VZV. Discrepants between the FDA cleared HSV ELISAs and the MRL device were analyzed using a type specific Western blot from a major university located in the Northwestern United States. Excluding one ELISA equivocal that was not analyzed with the Western blot because of insufficient volume, the results are:
| IFA IgG Pos | % MRL EL Neg | Ratio (n/N) | 95% CI |
|---|---|---|---|
| CMV | 100% | 12/12 | 73.5-100% |
| EBV VCA | 100% | 24/24 | 85.5-100% |
| HHV6 | 100% | 24/24 | 85.5-100% |
| VZV | 100% | 23/23 | 85.2-100% |
| Total | 100% | 83/83 | 95.7-100% |
5
510(k) Summary of Safety and Effectiveness (Page 6 of 6)
MRL assessed the device's intra-assay and inter-assay reproducibility using a slightly Intra-assay and modified version of "Evaluation of Precision Performance of Clinical Chemistry Devices", Inter-assay NCCLS Document EP5-T2 (March 1992). Briefly, seven samples were run in duplicate, Reproducibility twice a day, for twenty days, for a total of forty runs, for a total of forty data points for Study each sample. Two sets of samples were masked duplicates.
| Sample | Index Mean | Intra-assay
% CV | Inter-assay
% CV |
|--------|------------|---------------------|---------------------|
| 11* | 0.10 | 40.0% | 50.4% |
| 16* | 0.10 | 0.0% | 11.6% |
| 12** | 1.58 | 3.8% | 7.0% |
| 17** | 1.55 | 40.0% | 5.4% |
| 13 | 2.67 | 3.6% | 4.9% |
| 14 | 3.08 | 3.9% | 6.5% |
| 15 | 11.96 | 2.2% | 5.6% |
Intra-assay & Inter-assay Reproducibility
- #11 & #16 are masked duplicates. ** #12 & #17 are masked duplicates.
Inter-lot Reproducibility An internal investigator assessed the device's inter-lot reproducibility. Five samples were run on three separate days with three separate lots. For one lot, the samples were run in triplicate, and run in duplicate with the other two lots. Each of the three lots had at least a different lot of Antigen Wells. The results are:
| Sample | Index Mean | % CV |
|---|---|---|
| 11* | 0.09 | 26.8% |
| 16* | 0.09 | 20.2% |
| 12** | 1.47 | 8.2% |
| 17** | 1.41 | 2.9% |
| 13 | 2.48 | 11.1% |
| 14 | 2.64 | 9.4% |
| 15 | 10.85 | 25.1% |
Inter-lot Reproducibility
- #11 & #16 are masked duplicates. ** #12 & #17 are masked duplicates.
An internal investigator and two off site laboratories assessed the device's inter-laboratory Inter-laboratory Reproducibility reproducibility. Each of the three laboratories ran seven samples in triplicate on three different days.
| Inter-lab Reproducibility | |||
|---|---|---|---|
| Sample | Mean Index | %CV of | |
| Lab Means | Mean of | ||
| Lab %CVs | |||
| 11* | 0.15 | 6.6% | 70.9% |
| 16* | 0.15 | 23.6% | 63.1% |
| 12** | 1.44 | 13.5% | 7.0% |
| 17** | 1.48 | 13.0% | 4.3% |
| 13 | 2.37 | 10.8% | 5.7% |
| 14 | 2.72 | 10.7% | 7.5% |
| 15 | 14.24 | 24.3% | 64.6% |
- #11 & #16 are masked duplicates. ** #12 & #17 are masked duplicates.
800 445-0185
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
FEB 9 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael J. Wagner, Esq. Senior Regulatory Affairs Specialist MRL Diagnostics 10703 Progress Way Cypress, California 90630
K993754 Re: Trade Name: HSV-1 ELISA IgG Test Regulatory Class: III Product Code: MXJ Dated: January 31, 2000 Received: February 2, 2000
Dear Mr. Wagner:
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 Ouality System Regulation (OS) 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.
7
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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" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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
8
8993754 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
HSV-1 ELISA IgG
Indications for Use:
MRL Diagnostics' HSV-1 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the MRL HSV-2 ELISA IgG, the test is indicated for 1) testing sexually active adults, with or without a clinical history of herpes, for aiding in the presumptive diagnosis of HSV infection to identify persons who are at risk for transmitting or acquiring HSV so they may be counseled, and 2) testing expectant mothers for aiding in the presumptive assessment of the risk for acquiring and/or transmitting HSV to their child, so they may be counseled.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)