(146 days)
The LIAISON® HSV-2 Type Specific IgG assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the qualitative determination of type specific IgG antibodies to Herpes simplex virus Type 2 (HSV-2) in human serum. The assay is indicated for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection.
The LIAISON® HSV-2 Type Specific IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. The assay is neither FDA cleared nor approved for testing blood or plasma donors.
The LIAISON® Control HSV-2 (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HSV-2 Type Specific IgG assay.
The method for qualitative determination of specific IgG to HSV-2 is an indirect chemiluminescence immunoassay (CLIA). HSV-2 gG2 recombinant antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody is linked to an isoluminol derivative (isoluminolantibody conjugate), During the first incubation, HSV-2 antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HSV-2 IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of HSV-2 IgG concentration present in calibrators, samples or controls.
The information provided details the performance study for the LIAISON® HSV-2 Type Specific IgG assay, but it does not explicitly state pre-defined acceptance criteria for sensitivity and specificity that the device must meet. Instead, it presents the performance data and then concludes that the device performed equivalently to an FDA-cleared comparison method.
However, based on the provided data, we can infer the reported performance metrics.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
As mentioned, no explicit "acceptance criteria" are given in terms of numerical thresholds for sensitivity and specificity. The study aims to demonstrate "equivalent performance" to the predicate device. Therefore, the table below will list the reported performance values.
| Performance Metric | Acceptance Criteria (Inferred from "equivalent performance") | Reported Device Performance (LIAISON® HSV-2 Type Specific IgG) |
|---|---|---|
| Sexually Active Adults (n=401) | ||
| Sensitivity | Equivalent to predicate device | 98.1% (95% CI: 95.6 - 99.9%) |
| Specificity | Equivalent to predicate device | 98.0% (95% CI: 96.0 - 99.1%) |
| Expectant Mothers (n=430) | ||
| Sensitivity | Equivalent to predicate device | 94.8% (95% CI: 89.4 - 97.9%) |
| Specificity | Equivalent to predicate device | 97.3% (95% CI: 95.3 - 98.6%) |
| Low Prevalence Population (n=120) | ||
| Sensitivity | Equivalent to predicate device | 100% (95% CI: 86.1 - 100.0%) |
| Specificity | Equivalent to predicate device | 100% (95% CI: 97.0 - 100.0%) |
| CDC Panel (n=100) | ||
| Total Agreement with Positive | Equivalent to predicate device | 100% (52/52) |
| Total Agreement with Negative | Equivalent to predicate device | 100% (48/48) |
2. Sample size used for the test set and the data provenance:
- Total Test Set Sample Size: 951 samples for comparison against the FDA-cleared Immunoblot.
- 401 samples from Sexually Active Adults
- 430 samples from Expectant Mothers
- 120 samples from a "Low Prevalence" population
- Additionally, a 100-sample CDC panel (52% positive, 48% negative) was used for further performance assessment.
- Data Provenance:
- Country of Origin: Northeastern United States for the 951 samples. The CDC panel provenance is not specified beyond being from the Centers for Disease Control and Prevention.
- Retrospective or Prospective: Not explicitly stated, but the description "samples collected" and "samples obtained" suggests a retrospective collection of existing samples, rather than prospective enrollment for the purpose of this study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth was primarily established using an FDA-cleared Immunoblot (Predicate Device: Focus Diagnostics HerpeSelect® 1 and 2 Immunoblot IgG, K000238). For equivocal samples on the predicate device, Western Blot testing was performed by a Reference Laboratory in the Pacific Northwest.
- Number of Experts: Not applicable in the context of human expert review for independent ground truth. The initial ground truth was established by another diagnostic device (the predicate Immunoblot).
- Qualifications of Experts: Not applicable, as the primary ground truth was instrument-based. The "Reference Laboratory" for Western Blotting implies trained laboratory personnel, but specific qualifications are not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable in the traditional sense of multiple human readers adjudicating results. The ground truth was established by a predicate device, and for equivocal results from the predicate, a Western Blot was used for resolution. This acts as a form of reference method adjudication for indeterminate cases from the predicate.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, this was not a multi-reader multi-case comparative effectiveness study. This study compares the performance of a new in vitro diagnostic device (LIAISON® HSV-2 Type Specific IgG assay) against a legally marketed predicate device (FDA cleared Immunoblot). It does not involve human readers' interpretation of results that are enhanced or assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the study evaluated the LIAISON® HSV-2 Type Specific IgG assay as a standalone diagnostic device. It is an automated chemiluminescent immunoassay (CLIA) and its performance is measured independently against the predicate device and Western Blot as reference methods. It does not involve a human in the loop for interpreting the assay's primary output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: A combination of a legally marketed predicate device (FDA-cleared Immunoblot) and a reference laboratory method (Western Blot) for resolving equivocal results from the predicate device. This is a common approach for establishing ground truth in diagnostic device comparisons. The CDC panel serves as an external, well-characterized control for further validation.
8. The sample size for the training set:
- Training Set Sample Size: Not explicitly stated or provided in the document. The document describes a "comparative clinical trial" and "reproducibility study" for performance validation, not the development or training of the assay itself. The LIAISON® HSV-2 Type Specific IgG assay is an immunoassay, the "training" aspect is related to the assay's development and optimization, for which specific sample sizes are not typically released in 510(k) summaries for such devices.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not specified. As an immunoassay, its "training" involves optimizing reagents, concentrations, and reaction conditions during its development phase. The ground truth for this optimization would typically involve well-characterized positive and negative serum samples, likely confirmed by established reference methods (e.g., Western Blot, clinical diagnosis, culture), but these details are not part of the provided 510(k) summary focused on validation.
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L081687
NOV 1 0 2008
5.0 510(k) SUMMARY
Carol A. DePouw SUBMITTED BY: Regulatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5850 Fax (651) 351-5669 Email: carol.depouw@diasorin.com NAME OF DEVICE: LIAISON® HSV-2 Type Specific IgG Trade Name: LIAISON® Control HSV-2 IgG Common Names/Descriptions: Immunoassay for the detection of specific IgG antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum samples. Herpes Simplex Virus Serological Reagents Classification Names: MYF, JJX Product Code: Focus Diagnostics HerpeSelect® 1 and 2 PREDICATE DEVICE: Immunoblot IqG (K000238)
DEVICE DESCRIPTION:
INTENDED USE:
The LIAISON® HSV-2 Type Specific IgG assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the qualitative determination of type specific IgG antibodies to Herpes simplex virus Type 2 (HSV-2) in human serum. The assay is indicated for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection.
The LIAISON® HSV-2 Type Specific IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. The assay is neither FDA cleared nor approved for testing blood or plasma donors.
The LIAISON® Control HSV-2 (neqative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HSV-2 Type Specific IgG assay.
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KIT DESCRIPTION:
The method for qualitative determination of specific IgG to HSV-2 is an indirect chemiluminescence immunoassay (CLIA). HSV-2 gG2 recombinant antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody is linked to an isoluminol derivative (isoluminolantibody conjugate), During the first incubation, HSV-2 antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HSV-2 IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of HSV-2 IgG concentration present in calibrators, samples or controls.
PERFORMANCE DATA:
COMPARATIVE CLINICAL TRIALS
Studies were conducted which compared the LIAISON® HSV-2 Type Specific IgG assay to an FDA cleared Immunoblot. The studies were conducted on 951 samples collected in the Northeastern United States. The samples were classified as "At risk" samples (n=401) from Sexually Active Adults (at risk for a Sexually Transmitted Disease), Expectant Mothers (n=430) and a "Low Prevalence" population (n=120) from patients seen at the clinic for anything other than an STD. The studies were conducted at two (2) independent external laboratories.
The sample populations were divided between site 1 and site 2 for LIAISON® HSV-2 testing. Site 1 tested a total of 460 samples (201 Sexually Active Adults, 199 Expectant Mothers and 60 Low Prevalence). Site 2 tested a total of 491 samples (200 Sexually Active Adults, 231 Expectant Mothers and 60 Low Prevalence). Site 3 tested a total of 951 samples (401 Sexually Active Adults, 430 Expectant Mothers and 120 Low prevalence) with the FDA cleared Immunoblot. Equivocal samples were repeat tested as per the Instructions for use. Any repeat Equivocal samples on the predicate device were sent to a Reference Laboratory in the Pacific Northwest for Western Blot testing. The Western Blot results are included in the tables. All results are expressed as sensitivity and specificity with exact 95% Confidence Intervals.
Sexually Active Adults (401)
Four hundred one (401) samples were obtained from Sexually Active Adults who were seen at STD clinics in the Northeastern US were tested with the LIAISON® HSV-2 Type Specific IgG assay and the HSV-2 predicate method Immunoblot. Results are summarized below.
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| LIAISON®HSV-2 TypeSpecific IgG | Predicate Device | Total | ||
|---|---|---|---|---|
| Positive | Equivocal | Negative | ||
| Positive | 104 | 1 | 5 | 110 |
| Equivocal | 0 | 0 | 0 | 0 |
| Negative | 1 | 1 | 289 | 291 |
| Total | 105 | 2* | 294 | 401 |
| Percent | 95% Confidence Intervals | |
|---|---|---|
| Sensitivity | 98.1% (104/106) | 95.6 - 99.9% |
| Specificity | 98.0% (289/295) | 96.0 - 99.1% |
*Two samples were Indeterminate with Western Blot testing.
Expectant Mother Population (430)
Four hundred thirty (430) samples collected from Expectant Mothers in the Northeastern US were tested with the LIAISON® HSV-2 Type Specific IgG assay and the HSV-2 predicate method Immunoblot. Results are summarized below.
| LIAISON®HSV-2 TypeSpecific IgG | Predicate Device | Total | ||
|---|---|---|---|---|
| Positive | Equivocal | Negative | ||
| Positive | 91 | 0 | 8 | 99 |
| Equivocal | 1 | 0 | 1 | 2 |
| Negative | 4 | 0 | 325 | 329 |
| Total | 96 | 0 | 334 | 430 |
| Percent | 95% Confidence Intervals | |
|---|---|---|
| Sensitivity | 94.8% (91/96) | 89.4 - 97.9% |
| Specificity | 97.3% (325/334) | 95.3 - 98.6% |
Low Prevalence Population (120)
One hundred twenty (120) "Low Prevalence" samples obtained from patients who were seen at clinics (not for STD) in the Northeastern US were tested with the LIAISON® HSV-2 Type Specific IgG assay and the HSV-2 predicate method Immunoblot. Results are summarized below.
| LIAISON®HSV-2 TypeSpecific IgG | Predicate Device | Total | ||
|---|---|---|---|---|
| Positive | Equivocal | Negative | ||
| Positive | 20 | 0 | 0 | 20 |
| Equivocal | 0 | 0 | 0 | 0 |
| Negative | 0 | 0 | 100 | 100 |
| Total | 20 | 0 | 100 | 120 |
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| Percent | 95% Confidence Intervals | |
|---|---|---|
| Sensitivity | 100% (20/20) | 86.1 - 100.0% |
| Specificity | 100% (100/100) | 97.0 - 100.0% |
CDC Panel:
A serum panel was obtained from the Centers for Disease Control and Prevention and tested by the LIAISON® HSV-2 Type Specific IgG assay. The results are presented as a means of conveying further information on the performance of this assay with a characterized serum panel. This does not imply an endorsement of the assay by the CDC.
The panel consisted of 52% positive and 48% negative samples. The LIAISON® HSV-2 Type Specific IgG assay demonstrated 100% total agreement with the CDC positive results (52/52) and negative results (48/48).
Conclusion: The LIAISON® HSV-2 Type Specific IgG showed equivalent performance to the FDA cleared comparison method.
The results demonstrate that the LIAISON® HSV-2 Type Specific IgG assay can be used with the LIAISON® Analyzer for the qualitative determination of specific IgG antibodies to Herpes Simplex Virus Type 2 in human serum samples.
EXPECTED VALUES:
The prevalence may vary depending upon geographical location, age, gender, type of test employed, specimen collection and handling procedures as well as clinical history of the patient.
The observed and the hypothetical predictive values for the sexually active adults, expectant mothers and low prevalence populations are shown below. The positive predictive value (PPV) will decrease proportionally to the prevalence of HSV-2 infection as reflected in the table. The calculations are based on LIAISON® HSV-2 positive and negative agreements of 98.1% and 98.0%, respectively, in a sexually active adult population, 94.8% and 97.3%, respectively, in an expectant mothers population and both 100% in a low prevalence population.
| Population | Sero-Status | Observed Prevalence | |
|---|---|---|---|
| LIAISON | Predicate | ||
| Sexually Active Adults* | HSV-2 Negative | 72.7% (290/399) | 73.7%(294/399) |
| HSV-2 Positive | 27.3% (109/399) | 26.3%(105/399) | |
| Expectant Mothers** | HSV-2 Negative | 76.9% (329/428) | 77.8%(333/428) |
| HSV-2 Positive | 23.1% (99/428) | 22.2% (95/428) | |
| Low Prevalence | HSV-2 Negative | 83.3% (100/120) | 83.3% (100/120) |
| HSV-2 Positive | 16.7% (20/120) | 16.7% (20/120) |
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| Sexually Active Adults | Expectant Mothers | Low Risk Adults | ||||
|---|---|---|---|---|---|---|
| Prevalence | PPV | NPV | PPV | NPV | PPV | NPV |
| 80% | 99.5% | 92.8% | 99.3% | 82.4% | 100% | 100% |
| 70% | 99.1% | 95.7% | 98.8% | 88.9% | 100% | 100% |
| 60% | 98.7% | 97.2% | 98.1% | 92.6% | 100% | 100% |
| 50% | 98.0% | 98.1% | 97.2% | 94.9% | 100% | 100% |
| 40% | 97.0% | 98.7% | 95.9% | 96.6% | 100% | 100% |
| 30% | 95.5% | 99.2% | 93.8% | 97.8% | 100% | 100% |
| 20% | 92.5% | 99.5% | 89.8% | 98.7% | 100% | 100% |
| 10% | 84.5% | 99.8% | 79.6% | 99.4% | 100% | 100% |
*Excludes 2 Indeterminate results for Predicate device ** Excludes 2 Equivocal results for LIAISON device
HSV-2 Prevalence vs Hypothetical Predictive Values
REPRODUCIBILITY:
A reproducibility/precision study was conducted at two external laboratories and at DiaSorin Inc. This study included 3 LIAISON® HSV-2 Type Specific IgG Specific IgG Reagent Integral kit lots and 3 LIAISON® Analyzers. Each site used a different lot of the LIAISON® HSV-2 Type Specific IgG for the study.
A coded panel comprised of 8 frozen "engineered" serum samples was prepared by DiaSorin Inc. and provided to the sites. The coded panel samples were prepared by using neat positive serum or by blending positive and negative serum samples to achieve high negative, equivocal, low positive and high positive results. LIAISON® Control HSV-2 set were also included in the 5 day study. All panel members were divided into aliquots and stored frozen prior to testing. The CLSI document EP15-A2 was consulted in the preparation of the testina protocol.
The coded panel was tested at all three sites, using four replicates per run in two runs per day with different operators performing each run during five operating days. The mean, standard deviation, and coefficient of variation (%CV) of the results were computed for each of the tested specimens for each of the sites and across sites.
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| SampleID | N | MeanIndex | Withinrun%CV | Betweenrun%CV | Total(by site)%CV | Betweensite%CV | OverallSD | Overall%CV |
|---|---|---|---|---|---|---|---|---|
| NC | 120 | 0.04 | 51.4 | 54.7 | 66.4 | 78.3 | 0.03 | 83.2 |
| PC | 120 | 2.25 | 4.1 | 5.7 | 6.7 | 12.0 | 0.29 | 13.1 |
| HSV2A | 120 | 0.91 | 4.9 | 8.9 | 9.7 | 12.2 | 0.14 | 15.0 |
| HSV2B | 120 | 1.19 | 4.5 | 7.4 | 8.2 | 2.8 | 0.10 | 8.7 |
| HSV2C | 120 | 2.06 | 5.1 | 7.9 | 9.2 | 5.0 | 0.22 | 10.8 |
| HSV2D | 120 | 0.77 | 5.0 | 9.5 | 10.4 | 6.8 | 0.10 | 13.6 |
| HSV2E | 120 | 0.88 | 5.1 | 8.8 | 10.1 | 4.0 | 0.09 | 10.7 |
| HSV2F | 120 | 1.38 | 4.2 | 8.5 | 9.3 | 4.3 | 0.14 | 10.5 |
| HSV2G | 120 | 1.37 | 3.8 | 7.5 | 7.8 | 5.8 | 0.13 | 9.8 |
| HSV2H | 120 | 15.7 | 8.1 | 8.0 | 10.7 | 3.7 | 1.75 | 11.2 |
CONCLUSION:
The material submitted in this premarket notification is complete and supports a substantial equivalence decision. The labeling is sufficient and satisfies the requirements of 21CFR 809.10.
:
:
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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 symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol DePouw Regulatory Affairs Specialist Diasorin Inc. 1951 Northwestern Avenue P. O. Box 285 Stillwater, MN 55082-0285
Re: K081687 Trade/Device Name: LIAISON® HSV-2 Type Specific IgG Assay Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes Simplex Virus serological reagents Regulatory Class: Class II Product Code: MYF, JJX Dated: October 9, 2008 Received: October 10, 2008
DEC - 4 2008
Dear Ms. DePouw:
This letter corrects our substantially equivalent letter of Nov 10, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Uwe Sirf Ra
Sally A. Hojvat, M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
| 510(k) Number (if known): | K081687 |
|---|---|
| Device Name: | LIAISON® HSV-2 Type Specific IgG and LIAISON® Control HSV-2 IgG |
| Indications For Use: | The LIAISON® HSV-2 Type Specific IgG assay is achemiluminescent immunoassay (CLIA) to be used withthe LIAISON® Analyzer for the qualitative determinationof type specific IgG antibodies to Herpes Simplex VirusType 2 (HSV-2) in human serum. The assay is indicatedfor testing sexually active adults or expectant mothers toaid in the presumptive diagnosis of HSV-2 infection.The LIAISON® HSV-2 Type Specific IgG assay has notbeen established for use in the pediatrics population, forneonatal screening, or for testing immunocompromisedpatients. The assay is neither FDA cleared nor approvedfor testing blood or plasma donors.The LIAISON® Control HSV-2 (negative and positive) anintended for use as assayed quality control samples tomonitor the performance of the LIAISON® HSV-2 TypeSpecific IgG assay. |
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
ﺮ ﻣﺪﺭﻳﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
6081687 510(k) ______________________________________________________________________________________________________________________________________________________________________________
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Indication for Use
| 510(k) Number (if known): | K081687 |
|---|---|
| Device Name: | LIAISON® HSV-2 Type Specific IgG and LIAISON®Control HSV-2 IgG |
| Indications For Use: | The LIAISON® HSV-2 Type Specific IgG assay is achemiluminescent immunoassay (CLIA) to be used withthe LIAISON® Analyzer for the qualitative determinationof type specific IgG antibodies to Herpes Simplex VirusType 2 (HSV-2) in human serum. The assay is indicatedfor testing sexually active adults or expectant mothers toaid in the presumptive diagnosis of HSV-2 infection.The LIAISON® HSV-2 Type Specific IgG assay has notbeen established for use in the pediatrics population, forneonatal screening, or for testing immunocompromisedpatients. The assay is neither FDA cleared nor approvedfor testing blood or plasma donors.The LIAISON® Control HSV-2 (negative and positive) areintended for use as assayed quality control samples tomonitor the performance of the LIAISON® HSV-2 TypeSpecific IgG assay. |
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Uve Schul
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081687
§ 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).