(129 days)
951549, 980912, 973123
Not Found
No
The device description and performance studies focus on traditional immunoassay techniques and statistical analysis of results, with no mention of AI or ML algorithms for data processing or interpretation.
No
The BioPlex™ 2200 EBV IgG kit is an in vitro diagnostic device used to detect antibodies for diagnostic purposes, not to treat or prevent disease.
Yes
The device is intended for the "qualitative detection of IgG antibodies to three (3) separate EBV antigens" and can be used "as an aid in the laboratory diagnosis of infectious mononucleosis (IM)." This clearly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines a physical kit containing beads coated with proteins, reagents, and a system (BioPlex 2200 System) that processes these physical components and samples. This involves hardware and chemical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens... in human serum." This clearly indicates that the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes (aiding in the laboratory diagnosis of infectious mononucleosis).
- Device Description: The description details how the device works by analyzing components in a human sample (serum) using a multiplex flow immunoassay to detect antibodies.
- Performance Studies: The document describes performance studies conducted using human serum samples to evaluate the device's accuracy and reliability in detecting EBV antibodies.
- Predicate Devices: The mention of predicate devices (other EBV IgG ELISA kits) further confirms that this device falls within the category of diagnostic tests.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
BioPlex 2200 EBV IaG Kit
The BioPlex™ 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.
BioPlex 2200 EBV IgG Calibrator Set
The BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.
BioPlex 2200 EBV IgG Control Set
The BioPlex 2200 EBV IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 EBV IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgG Control Set has not been established with any other EBV assays.
Product codes (comma separated list FDA assigned to the subject device)
LSE
Device Description
The EBV 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. Three (3) different populations of beads are coated with E. coli derived recombinant proteins, EBV NA-1 (28kD and 45kD), EBV VCA p18 (40kD), and EBV EA-D (28kD) associated with infectious mononucleosis.12-13 The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, antihody, 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 or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information. The instrument is calibrated using a set of seven (7) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. The result for each of these antibodies is expressed as an antibody index (AI).
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
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Expected Values
Expected values for the EBV IgG kit are presented by age and gender in Tables 13 - 18 for serum samples from unselected hospitalized pediatric and adult patients (N=303) and patients for which an EBV test was ordered (N=620). A total of 621 serum samples from patients for which an EBV test was ordered were tested. One (1) sample from the patients for which an EBV test was ordered population was excluded due to RBB analysis error messages during BioPlex 2200 EBV IgG testing. For all analytes, results of ≤0.8 Al are negative, 0.9 and 1.0 Al are equivocal, and ≥1.1 Al are reported as positive.
B. Reproducibility Studies
A reproducibility panel, consisting of nine (9) panel members was prepared by Bio-Rad Laboratories. Two (2) of the nine (9) panel members had high levels of EBV NA-1 and EBV VCA: two (2) of the nine (9) panel members had high levels of EBV EA-D; two (2) of the nine (9) panel members had antibody levels near the cutoff for EBV NA-1 and EBV VCA; two (2) of the nine (9) panel members had antibody levels near the cutoff for EBV EA-D. All were prepared from positive patient samples. One (1) of the nine (9) panel members was negative for all three (3) analytes contained in the BioPlex 2200 EBV IqG kit. In addition, three (3) lots of the EBV IgG Control Set [1 positive control (antibody positive) and a negative control (antibody negative)} were also tested.
Reproducibility testing was performed at each of three (3) US testing facilities on a total of three (3) lots of the EBV IgG kit, three (3) lots of the EBV IgG Calibrator Set and three (3) lots of the EBV IgG Control Set. Each testing facility evaluated reproducibility using one (1) kit lot of EBV lgG with matched calibrators and controls. The panels were provided to each of the testing sites. Each of the nine (9) panel members and positive and negative controls was tested in quadruple (x4) on each day for three (3) days at each of three (3) US testing facilities using one (1) lot of EBV IgG reagent pack, one (1) lot of EBV IgG Calibrator Set and one (1) lot of EBV IgG Control Set (4 times x 3 days x 3 sites = 36 replicates per panel member and controls). The data were analyzed for intra-assay and inter-assay reproducibility according to the principles described in the Clinical Laboratory Standards Institute guidance EP5-A2, revised November 2004 and ISO/TR 22971:2205. The standard deviation (SD) and percent coefficient of variation (%CV) were calculated. Positive results can be found in Tables 19 - 21.
C. Precision Studies
A precision panel, consisting of six (6) panel members was prepared by Bio-Rad Laboratories. Two (2) of the six (6) panel members had high levels of the antibodies contained in the BioPlex 2200 EBV IgG kit (EBV NA-1 IgG, EBV VCA IgG, and EBV EA-D IgG) and two (2) of the six (6) panel members had antibody levels near the cutoff, both prepared from positive patient samples, Two (2) of the six (6) panel members were negative (one high negative and one low negative) for both of the analytes.
Precision testing was performed at Bio-Rad Laboratories on one lot of the EBV IgG kit, one lot of the EBV IgG Calibrator Set and one lot of the EBV IgG Control Set. Each of the six (6) panel members was tested in duplicate (x2) on two (2) runs per day for ten (10) days using one (1) lot of EBV IgG kit, one (1) lot of EBV IgG Calibrator Set and one (1) lot of EBV IgG Control Set (2 times x 2 runs x 10 days = 40 replicates per panel member). The data were analyzed for intraassay and inter-assay precision according to the principles described in the Clinical Laboratory Standards Institute guidance EP5-A2, revised November 2004 and ISO/TR 22971:2205. The standard deviation (SD) and percent coefficient of variation (%CV) were calculated. Results can be found in Tables 22 - 24.
D. Comparative Testing
Performance of the BioPlex 2200 EBV IqG kit was tested against corresponding commercially available microplate EIAs. A total of 621 banked serum samples from patients for which an EBV test was ordered were tested at 3 U.S. clinical testing sites. The BioPlex 2200 EBV IgG kit was run in conjunction with the BioPlex 2200 EBV IgM kit to allow for a complete antibody response profile. The characterization by antibody response was not compared with clinical data regarding presence, absence or status of disease. Two (2) samples were excluded due to RBB analysis error messages during BioPlex 2200 EBV IgM testing. One (1) sample was excluded due to RBB analysis error messages during BioPlex 2200 EBV IgG testing. Using Table 25 as a guideline, results were analyzed by BioPlex 2200 EBV IgG analytes and corresponding EBV IgG reference assays according to serological characterization based on reference assay results. For the purpose of percent agreement calculations, BioPlex 2200 EBV IgG equivocal results were assigned to the opposite clinical interpretation than that of the corresponding reference assay result. Likewise, the reference IgG assay equivocal results were assigned to the opposite clinical interpretation than that of the corresponding BioPlex 2200 EBV IgG result. Results from all sites are shown and summarized in Tables 26 - 31.
Using Table 25 as a guideline, samples characterized into serological status associated with EBV disease, using the commercially available microplate EIA and agglutination tests, were compared with characterizations using BioPlex 2200 EBV IgG and IgM kits. The EBV IgG kit was run in conjunction with the EBV IgM kit to allow for a complete antibody response profile. The characterization by antibody response was not compared with clinical data regarding presence, absence or status of disease. Results from 618 serum samples tested at 3 U.S. clinical testing sites are shown in Table 32.
The results obtained from the summarized information provided in Table 32 were further classified into two groups; Acute Infection and Non-Acute Infection. Acute Infection includes Primary Acute and Late Acute. Non-Acute Infection includes samples characterized as Susceptible, Recovering and Previous Infection as defined in Table 25. Inconclusive includes any samples whose patterns of antibody reactivity are not consistent with any category listed in Table 25. Results are summarized in Table 33.
E. Cross-Reactivity
A cross-reactivity study was performed to determine if samples from various disease states and other potentially interfering factors interfere with test results when tested with the BioPlex 2200 EBV IgG kit. A panel of ten (10) specimens* positive for each cross reactant were evaluated for possible cross reactivity with the BioPlex 2200 EBV IgG kit for each of the three EBV IgG antibody assays. Due to the high prevalence of EBV IgG antibodies in the normal population, the test specimens were also evaluated on corresponding commercially available microplate EIAs. Most of the samples evaluated were high positive for each disease state. The majority of all samples that did elicit a positive result were also confirmed positive by the corresponding commercially available microplate EIA, indicating reactivity to EBV IgG antibodies rather than cross reactivity with a potentially interfering factor. Results can be found in Table 34.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
EBV NA-1 IgG:
- Positive Agreement: 95.6% (409/428), 95% CI: 93.2 - 97.1%
- Negative Agreement: 97.4% (185/190), 95% CI: 94.0 - 98.9%
EBV VCA IgG:
- Positive Agreement: 96.2% (426/443), 95% CI: 93.9 - 97.6%
- Negative Agreement: 99.4% (174/175), 95% CI: 96.8 - 99.9%
EBV EA-D IgG:
- Positive Agreement: 88.1% (104/118), 95% CI: 81.1 - 92.8%
- Negative Agreement: 84.1% (417/496), 95% CI: 80.6 - 87.0%
Overall Serological Agreement for EBV Serological Status: 83.3%, 95% Confidence Interval: 80.2 - 86.1% (based on comparison with Commercially Available Assays vs. BioPlex 2200 EBV IgG & IgM Profile)
Overall Serological Agreement for Acute and Non-acute EBV Serological Status: 85.1%, 95% Confidence Interval: 82.1 - 87.7%
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.
951549, 980912, 973123
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
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).
0
KOG22//
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in white text on a black background. The text is bold and sans-serif.
BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS 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.
DEC - 8 2005
| 510(k) Number | 510(k) Summary Report Date |
|---|---|
| K062211 | December 7, 2006 |
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 EBV 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 | Epstein Barr Virus, Other (LSE) | |
|---|---|---|
| Common Name: | Multi-Analyte Detection System EBV IgG | |
| Product Trade Name | BioPlex 2200 EBV IgG Panel on the BioPlex 2200 Multi- | |
| Analyte Detection System | ||
| BioPlex 2200 EBV IgG Control Set | ||
| BioPlex 2200 EBV IgG Calibrator Set | ||
| Device Class | Class I | |
| Classification Panel | Microbiology | |
| Regulation Number | 866.3235 |
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is white text on a black rounded rectangle. The text is in a bold, sans-serif font.
| | BioPlex2200 EBV
IgG Analyte | Comparative FDA Cleared
PREDICATE DEVICE | 510(k)
Number | Decision
Date |
|----|--------------------------------|---------------------------------------------|------------------|------------------|
| 1. | EBV NA-1 | Captia EBV (EBNA-1) IgG ELISA | 951549 | 4/29/96 |
| 2. | EBV VCA | Captia EBV VCA (P-18) IgG ELISA | 980912 | 3/26/98 |
| 3. | EBV EA-D | Captia EBV EAD IgG ELISA | 973123 | 7/22/98 |
LEGALLY MARKETED EQUIVALENT (SE) DEVICES
DEVICE DESCRIPTION
The EBV 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. Three (3) different populations of beads are coated with E. coli derived recombinant proteins, EBV NA-1 (28kD and 45kD), EBV VCA p18 (40kD), and EBV EA-D (28kD) associated with infectious mononucleosis.12-13 The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, antihody, 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 or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information. The instrument is calibrated using a set of seven (7) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. The result for each of these antibodies is expressed as an antibody index (AI).
KIT COMPONENTS
EBV IgG Reagent Pack (Catalog No. 665-1250). The reagent pack contains supplies sufficient for 100 tests.
| Vial | Description |
|---|---|
| Bead Set | One (1) 10 mL vial, containing 3 different populations of dyed beads coated |
| with affinity-purified E. coli derived recombinant proteins to EBV NA-1 | |
| (28kD and 45kD), EBV VCA p18 (40kD), EBV EAD (28kD); an Internal | |
| Standard (ISB), a Serum Verification (SVB), and a Reagent Blank (RBB); | |
| with Glycerol and protein stabilizers (bovine) in a MOPS (3-[N-Morpholino] | |
| propanesulfonic acid) buffer. ProClin® 300 (0.3%) and sodium azide | |
| (E. coli | 4 |
| Pregnant women | 10 |
*One Equivocal Sample; **Two Equivocal Samples
20
Image /page/20/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David Bhend Regulatory Affairs Associate Bio-Rad Laboratories, Inc. Diagnostics Group 6565 185th Ave, N.E. Redmond, WA 98052
DEC - 8 2006
Re: K062211
Trade/Device Name: BioPlex 2200 EBV IgG Panel on the BioPlex 2200 Multi-Analyte Detection System BioPlex 2200 EBV IgG Control Set BioPlex 2200 EBV IgG Calibrator Set Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LSE Dated: November 13, 2006 Received: November 14, 2006
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 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).
21
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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.
Sincerely yours,
face, am
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
22
INDICATIONS FOR USE STATEMENT
510(k) Number: K062211
BioPlex 2200 EBV IgG Kit on the BioPlex 2200 Multi-Analyte Device Name: Detection System BioPlex 2200 EBV IqG Control Set BioPlex 2200 EBV IgG Calibrator Set
Indications for Use:
BioPlex 2200 EBV laG Kit
The BioPlex™ 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM).
The EBV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkit's lymphoma, and other EBV-associated lymphomas.
BioPlex 2200 EBV IqG Calibrator Set
The BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.
BioPlex 2200 EBV IgG Control Set
The BioPlex 2200 EBV IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 EBV IqG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgG Control Set has not been established with any other EBV assays.
Prescription Use: × ______________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use: (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________