(79 days)
Not Found
No
The description focuses on traditional immunoassay methodology and data processing (RFI calculation) without mentioning AI or ML algorithms for analysis or interpretation.
No
This device is a diagnostic tool used to detect antibodies for HSV-1 and HSV-2, aiding in the diagnosis of infection. It does not provide therapy or treatment.
Yes
Explanation: The device is intended "as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection" by detecting and differentiating IgG antibodies, which directly aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical kit containing dyed beads coated with antigens, reagents, and is intended for use with a specific hardware system (Bio-Rad BioPlex 2200 System). This indicates it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description details a "multiplex flow immunoassay" that uses patient samples and reagents to detect antibodies. This is a typical in vitro diagnostic methodology.
- Performance Studies: The document describes performance studies conducted using human serum samples to evaluate the device's accuracy (sensitivity, specificity, agreement) in detecting the target antibodies. This is a requirement for IVD devices.
- Predicate Devices: The mention of predicate devices (Focus HerpesSelect 1 ELISA IgG, Focus HerpesSelect 2 ELISA IgG, Focus HerpesSelect 1 and 2 Immunoblot IgG) which are also IVDs, further supports that this device falls into the same category.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioPlex™ 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
The BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
Product codes (comma separated list FDA assigned to the subject device)
MXJ, MYF
Device Description
The BioPlex 2200 HSV-1 & HSV-2 IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube.
Two different populations of dyed beads are each coated with antigens associated with herpes simplex virus, types 1 and 2. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead set reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel and the absence of significant non-specific binding in serum. Refer to the BioPlex 2200 System Operation Manual for more information.
The instrument is calibrated using a set of 4 distinct calibrator vials, supplied separately by Bio-Rad Laboratories.
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 performance of this assay has not been established for use in a pediatric population, neonates. The test is indicated for sexually active individuals and 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
Performance of the BioPlex 2200 HSV-1 & HSV-2 IgG kit in the intended use populations was tested against a commercially available immunoblot test in a prospective study conducted at a total of 3 U.S. clinical sites. For purposes of sensitivity calculations, the BioPlex 2200 equivocal results were assigned to the opposite clinical interpretation than that of the corresponding immunoblot result. Likewise, immunoblot equivocal results were assigned to the opposite clinical interpretation than that of the BioPlex 2200 result.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance in Sexually Active Individuals
The sensitivity and specificity of the HSV-1 & HSV-2 IgG kit was assessed using remnant serum samples from sexually active individuals where an HSV-1 test was ordered (N=289) and sexually active individuals where an HSV-2 test was ordered (N=286). Samples were tested at 3 U.S. clinical sites.
Performance in Expectant Mothers
The sensitivity and specificity of the HSV-1 & HSV-2 IgG kit was assessed using remnant serum samples from expectant mothers (N=399).
Agreement with CDC Panel
The performance of the BioPlex 2200 HSV-1 & HSV-2 IgG kil was assessed using a masked, well characterized HSV serum panel from the CDC. The panel consists of 24% HSV-1 and HSV-2 dual-positive samples, 50% HSV-1 positive and 50% HSV-1 negative samples and 48% HSV-2 positive and 52% HSV-2 negative samples. N=100.
Performance in a Low Prevalence Population
The sensitivity and specificity of the HSV-1 & HSV-2 IgG kit was assessed using remnant serum samples from a low-prevalence population, collected in a non-STD setting, in people age 16-19 (N=200). Samples were tested at 2 U.S. clinical testing sites.
Reproducibility Studies
A reproducibility panel was prepared at Bio-Rad Laboratories, consisting of 8 panel members and the HSV-1 & HSV-2 IgG positive control, made from diluted patient sera. Reproducibility testing was performed at 2 external evaluation sites and internally at Bio-Rad Laboratories using 3 lots of the HSV-1 & HSV-2 IgG Reagent Pack, 3 lots of the HSV-1 & HSV-2 IgG Calibrator set and 3 lots of the HSV-1 & HSV-2 IgG Control set (one lot at each site). Each of the reproducibility panel members were tested in duplicate on two runs per day, for 5 days, on 3 lots (2 replicates x 2 runs x 5 days x 3 lots = 60 replicates per panel member). The data were analyzed for intra-assay and inter-assay reproducibility.
Precision Studies
A Precision panel, consisting of 8 panel members, was prepared by Bio-Rad Laboratories. For each analyte, 2 of the 8 panel members had high positive levels of the antibodies, 2 had low positive levels of the antibodies, and 2 had antibody levels near the cutoff; additionally there were 2 high negative panel members. Precision testing was performed at Bio-Rad Laboratories on one lot of the HSV-1 & HSV-2 IgG Reagent Pack, one lot of the HSV-1 & HSV-2 IgG Calibrator Set and one lot of the HSV-1 & HSV-2 IgG Control Set. Each of the 8 panel members was tested in duplicate (x2) on 2 runs per day for 20 days (2 times x 2 runs x 20 days = 80 replicates per panel member). The data were analyzed for intra-assay and inter-assay precision.
Cross-Reactivity
A cross-reactivity study was performed to determine if samples from various disease states and other potentially cross-reacting agents interfere with test results when tested with the BioPlex 2200 HSV-1 & HSV-2 IgG kit. Samples known to be positive for one of the twenty potential cross-reactants listed in the table were evaluated. All samples were pre-tested by a commercially available HSV-1 and HSV-2 IgG immunoblot assay and only those that tested negative by the immunoblot assay were further tested by the BioPlex 2200 HSV-1 & HSV-2 IgG kit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Summary Performance of the BioPlex 2200 HSV-1 and HSV-2 IgG Assay
-
Sexually Active Individuals With an HSV-1 Test Ordered (N = 289):
- HSV-1 IgG % Sensitivity: 97.6% (202/207), 95% Confidence Interval: 94.5-99.0%
- HSV-1 IgG % Specificity: 90.1% (73/81), 95% Confidence Interval: 81.7-94.9%
-
Sexually Active Individuals With an HSV-2 Test Ordered (N = 286):
- HSV-2 IgG % Sensitivity: 90.6% (106/117), 95% Confidence Interval: 83.9-94.7%
- HSV-2 IgG % Specificity: 98.2% (166/169), 95% Confidence Interval: 94.9-99.4%
-
Expectant Mothers (N = 399):
- HSV-1 IgG % Sensitivity: 96.3% (287/298), 95% Confidence Interval: 93.5-97.9%
- HSV-1 IgG % Specificity: 99.0% (100/101), 95% Confidence Interval: 94.6-99.8%
- HSV-2 IgG % Sensitivity: 96.9% (157/162), 95% Confidence Interval: 93.0-98.7%
- HSV-2 IgG % Specificity: 100% (237/237), 95% Confidence Interval: 98.4-100%
-
CDC Panel (N = 100):
- HSV-1 IgG % Sensitivity: 100% (50/50), 95% Confidence Interval: 92.8-100%
- HSV-1 IgG % Specificity: 96.0% (48/50), 95% Confidence Interval: 86.5-98.9%
- HSV-2 IgG % Sensitivity: 100% (50/50), 95% Confidence Interval: 92.8-100%
- HSV-2 IgG % Specificity: 100% (50/50), 95% Confidence Interval: 92.8-100%
-
Low Prevalence [16-19 years] (N = 200):
- HSV-1 IgG % Sensitivity: 93.3% (97/104), 95% Confidence Interval: 86.7-96.7%
- HSV-1 IgG % Specificity: 97.9% (94/96), 95% Confidence Interval: 92.7-99.4%
- HSV-2 IgG % Sensitivity: 73.3% (11/15) - Note: Insufficient positive samples for statistically meaningful % sensitivity.
- HSV-2 IgG % Specificity: 97.8% (181/185), 95% Confidence Interval: 94.6-99.2%
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.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. The text is white and bolded, and it is set against a black background. The logo is encased in a rounded rectangle.
BIOPLEX 2200 HSV-1 AND HSV-2 IgG 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 . . . . . . . . . . . .
| -------------------------------------
No. of Can't Canadian
ALLANDA AND AN
CANALI
2
Change & A Box Corporation | -------------------------------------------------------------------------------
lato
CARD COLLECTION COLLECT |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
of them of called of claims and a part
1000100 | AAA
-------------------------------------- |
MANUFACTURER INFORMATION
| Manufacturer | |
|---|---|
| Manufacturer Address | Bio-Rad Laboratories, Inc. |
| Clinical Systems Division | |
| 4000 Alfred Nobel Drive | |
| Hercules, CA 94547 | |
| Telephone | (510) 724-7000 |
| Establishment Registration No. | 2915274 |
| Owner / Operator | Bio-Rad Laboratories, Inc. |
| 4000 Alfred Nobel Drive | |
| Hercules, CA 94547 | |
| Owner / Operator No. | 9929003 |
| Official Correspondent for the BioPlex 2200 HSV-1 and HSV-2 IgG | |
| Official Correspondent Address | Bio-Rad Laboratories |
| 6565 185th Ave NE | |
| Redmond, WA 98052 | |
| Telephone | 425-881-8300 |
| Establishment Registration No. | 3022521 |
| Owner / Operator | Bio-Rad Laboratories |
| 6565 185th Ave NE | |
| Redmond, WA 98052 | |
| Official Correspondent | Mr. Christopher Bentsen |
| Telephone | (425) 498-1709 |
| Fax | (425) 498-1651 |
CLASSIFICATION INFORMATION
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Classification Name | Enzyme Linked Immunosorbent Assay, Herpes Simplex
Virus, HSV-1 |
|----------------------|----------------------------------------------------------------------------------------|
| Common Name | Multi-Analyte Detection System HSV-1 and HSV-2 IgG |
| Product Trade Name | BioPlex 2200 HSV-1 and HSV-2 IgG on the BioPlex 2200
Multi-Analyte Detection System |
| Device Class | Class II |
| Classification Panel | Microbiology |
| Regulation Number | 866.3305 |
| Product Code | MXJ |
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)
1
Image /page/1/Picture/0 description: The image shows the logo for BIO-RAD. The text is in white and the background is black. The logo is in a rounded rectangle.
| Classification Name | Enzyme Linked Immunosorbent Assay, Herpes Simplex
Virus, HSV-2 |
|----------------------|----------------------------------------------------------------------------------------|
| Common Name: | Multi-Analyte Detection System HSV-1 and HSV-2 IgG |
| Product Trade Name | BioPlex 2200 HSV-1 and HSV-2 IgG on the BioPlex 2200
Multi-Analyte Detection System |
| Device Class | Class II |
| Classification Panel | Microbiology |
| Regulation Number | 866.3305 |
| Product Code | MYF |
LEGALLY MARKETED EQUIVALENT (SE) DEVICES
| Comparative FDA Cleared
PREDICATE DEVICE | 510(k) Number | Decision
Date |
|---------------------------------------------|---------------|------------------|
| Focus HerpesSelect 1 ELISA IgG | K021429 | 7/29/2002 |
| Focus HerpesSelect 2 ELISA IgG | K021486 | 8/1/2002 |
| Focus HerpesSelect 1 and 2 Immunoblot IgG | K000238 | 4/14/2000 |
DEVICE DESCRIPTION
The BioPlex 2200 HSV-1 & HSV-2 IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube.
Two different populations of dyed beads are each coated with antigens associated with herpes simplex virus, types 1 and 2. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead set reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI).
Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel and the absence of significant non-specific binding in serum. Refer to the BioPlex 2200 System Operation Manual for more information.
1 37011-11 14:00LL
The instrument is calibrated using a set of 4 distinct calibrator vials, supplied separately by Bio-Rad Laboratories.
onch conted with anliner thear i
BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)
Page 2 of 17
2
Image /page/2/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in white text on a black background. The text is bold and slightly rounded.
KIT COMPONENTS
BioPlex 2200 HSV-1 & HSV-2 IgG Reagent Pack ( 665-3350). The reagent pack contains supplies sufficient for 100 tests.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing dyed beads coated with HSV-1 and HSV-2 |
| IgG antigens, an Internal Standard bead (ISB), a Serum Verification bead | |
| (SVB), and a Reagent Blank bead (RBB) in buffer with Glycerol and protein | |
| stabilizers (bovine). ProClin™ 300 (0.3%), sodium benzoate (0.1%) and | |
| sodium azide (N. gonorrhea | 4 |
| HPV IgG | 10 |
| C. trachomatis | 5 |
| HIV | 10 |
| Rheumatoid Factor | 7 |
| Bacterial Vaginosis | |
| - Bacteroides sp. | N/A |
| - Trichonomis | 10 |
| - Mobiluncus sp. | 1 |
| - Gardenella vaginalis | 10 |
Table 28: Cross-Reactivity
- One (1) HCV sample was identified as low positive for HSV-2 by the BioPlex 2200 HSV-2 IgG assay with an Al value of 1.3.
At Two (2) Bacteroides sp. samples were identified HSV-2 equivocal and low positive with Al values of 1.0 and 1.1, respectively, by the BioPlex 2200 HSV-2 IgG assay.
N/A = Not available
BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)
Page 17 of 17
17
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/17/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 8 2009
David V. Bhend Regulatory Affairs Representative Bio-Rad Laboratories 6565 185th Ave. NE Redmond, WA 98052
K090409 Re:
R090407
Trade/Device Name: BioPlex™ 2200 HSV-1 and HSV-2 IgG Kit Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological reagents Regulatory Class: Class II Product Code: MXJ,MYF Dated: February 17, 2009 Received: February 18, 2009
Dear Mr. Bhend:
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 with the provisions of approval application (PMA). You may, therefore, market the approvision of a provisions of the Act. The Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, provisions of the roo ractice, 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 (1 wa t), it may 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 I oderal agencies: "1 on ind 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).
18
Page 2 -
Enclosure
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attym
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
19
Indication for Use
510(k) Number (if known): K090409
Device Name: BioPlex 2200 HSV-1 and HSV-2 IgG kit on the BioPlex 2200 Multi-Analyte Detection System
Indication For Use:
The BioPlex™ 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
The BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
Prescription Use
(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)
Ure Schuf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070404
Page 1 of 1