WEST NILE VIRUS ELISA IGG, MODEL EL0300G

K031953 · Focus Technologies, Inc. · NOP · Oct 22, 2003 · Microbiology

Device Facts

• Record ID: K031953
• Device Name: WEST NILE VIRUS ELISA IGG, MODEL EL0300G
• Applicant: Focus Technologies, Inc.
• Product Code: NOP · Microbiology
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3940
• Device Class: Class 2

Intended Use

The Focus Technologies West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.

Device Story

Indirect IgG ELISA; detects IgG antibodies to West Nile virus in human serum. Polystyrene microwells coated with recombinant West Nile virus antigen; patient serum incubated; specific IgG binds to antigen; peroxidase-conjugated anti-human IgG added; enzyme substrate/chromogen added for color development. Color change quantified via spectrophotometric optical density (OD) reading; compared to reference cut-off OD. Used in clinical laboratories; performed by trained laboratory personnel. Results aid presumptive diagnosis of West Nile virus infection in symptomatic patients; positive results require confirmation via neutralization test or CDC guidelines. Not for blood/plasma donor screening or self-testing.

Clinical Evidence

Clinical performance evaluated across four study sites. In 300 patients with encephalitis/meningitis, clinical sensitivity was 97.3% (36/37) against confirmed WNV PRNT-positive cases. Negative agreement with presumptive CDC WNV IgG ELISA negative samples was 99.0% (203/205). Cross-reactivity assessed against various pathogens (Dengue, SLE, Japanese encephalitis, etc.). Reproducibility studies (inter-lot, intra/inter-assay, inter-laboratory) performed with CVs ranging from 1.0% to 22.3%.

Technological Characteristics

Indirect IgG ELISA; polystyrene microwells coated with recombinant West Nile virus antigen. Detection via peroxidase-conjugated anti-human IgG and spectrophotometric OD measurement. Manual assay; no automated instrument performance established.

Indications for Use

Indicated for testing human serum in patients with symptoms of meningioencephalitis to aid in the presumptive laboratory diagnosis of West Nile virus infection. Not for self-testing or blood/plasma donor screening.

Regulatory Classification

Identification

West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See § 866.1(e) for the availability of this guidance document.

Predicate Devices

• PanBio West Nile Virus IgM Capture ELISA (K031703)

Submission Summary (Full Text)

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OCT 2 2 2003

Image /page/0/Picture/1 description: The image shows the logo for Focus Technologies. The logo consists of the word "FOCUS" in a bold, sans-serif font, with two crescent moon shapes forming the letter "O". Below the word "FOCUS" is the word "technologies" in a smaller, sans-serif font. The logo is black and white.

031953

| Applicant | Focus Technologies, Inc.<br>10703 Progress Way<br>Cypress, California 90630<br>USA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration No. | 2023365 |
| Contact Person | Michael J. Wagner, Esq.<br>tel [phone]<br>fax [phone]<br>[e-mail] |
| Summary Date | October 17, 2003 |
| Proprietary Name | West Nile Virus ELISA IgG |
| Generic Name | West Nile Virus ELISA IgG |
| Classification | West Nile Virus Serological Reagents<br>21 CFR §866.3940<br>Class II |
| Predicate Device | Focus Technologies Arbovirus IFA IgG (K913617)<br>Focus Technologies HSV-2 ELISA (K993724)<br>CDC West Nile Virus IgG ELISA<br>West Nile Virus Plaque Reduction Neutralization Test |

#### Device Description

Indirect Enzyme-linked immunosorbent assay for qualitatively detecting human serum IgG antibodies to West Nile virus.

#### Intended Use

The Focus Technologies West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.

#### Test Principle

In the Focus Technologies West Nile Virus ELISA IgG assay, the polystyrene microwells are coated with recombinant West Nile virus antigen. Diluted serum samples and controls are incubated in the wells to allow anti-WNV IgG antibody (if present in the sample) to react with the antigen. Nonspecific reactants are removed by washing and peroxidaseconjugated anti-human IgG is added that reacts with human IgG bound to the antigen. 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 readings are compared with reference cut-off OD readings to determine results.

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## K031953 510(k) Summary of Safety and Effectiveness West Nile Virus ELISA IgG Catalog No. EL0300G Prepared October 17, 2003

#### Expected Values

The prevalence of West Nile antibodies varies depending age, geographic location, testing method used, and other factors. A community based serosurvey for West Nile infection conducted in New York in 2000 found that 0.2% (5/2433) of persons tested overall had antibodies indicating recent West Nile infection, and that 1.1% (2/176) of persons reporting a recent headache and fever had antibodies indicating a recent West Nile infection. Two serosurveys conducted in New York City (NYC) in 1999 and 2000 showed that approximately 1 in 150 infections (<1%) resulted in meningitis or encephalitis. The NYC results are consistent with a 1996 Romanian serosurvey indicating that 1:140 to 1:320 infections resulted in meningitis or encephalitis.

### Prevalence in Samples Submitted for Non-Flavivirus Testing (n=476)

Focus assessed reactivity with 476 samples prospectively collected from North America during August 2003. The samples had been submitted to a clinical laboratory located in Southern California for non-flavivirus tests (e.g., tests for other infectious diseases). The samples consisted of 64.1% females, and 1.5% samples from persons of unspecified gender.

| Age | Neg | Eqv | Pos | % Positive | 95%CI |
|----------|-----|-----|-----|---------------|-----------|
| 0 to 9 | 20 | 0 | 4 | 16.7% (4/24) | 4.7-37.4% |
| 10 to 19 | 25 | 2 | 2 | 6.9% (2/29) | 0.9-22.8% |
| 20 to 29 | 63 | 4 | 3 | 4.3% (3/70) | 0.9-12.0% |
| 30 to 39 | 76 | 1 | 5 | 6.1% (5/82) | 2.0-13.7% |
| 40 to 49 | 69 | 1 | 8 | 10.3% (8/78) | 4.5-19.2% |
| 50 to 59 | 47 | 1 | 3 | 5.9% (3/51) | 1.2-16.2% |
| 60 to 69 | 32 | 1 | 6 | 15.4% (6/39) | 5.9-30.5% |
| 70 to 79 | 28 | 1 | 5 | 14.7% (5/34) | 5.0-31.1% |
| 80+ | 15 | 1 | 2 | 11.1% (2/18) | 1.4-34.7% |
| Unknown | 41 | 2 | 8 | 15.7% (8/51) | 7.0-28.6% |
| Overall | 416 | 14 | 46 | 9.7% (46/476) | 7.2-12.7 |

#### IgG Prevalence with Samples Submitted for Non-Flavivirus Testing(n = 476)

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# K031953

### Performance Characteristics

### Study Site 1: Focus Reactivity with Encephalitis/Meningitis Patients (n = 300)

A state department of health laboratory located in the northeastern U.S. assessed the device's reactivity from encephalitis/meningitis patients (n = 300). Patients were suspected of having either viral encephalitis or viral meningitis.

Viral encephalitis criteria included:

- 1) fever:
- 2) altered mental status and/or other evidence of cortical involvement; and
- 3) CSF pleocytosis with predominant lymphocytes and/or elevated protein and a negative gram stain and culture.

Viral meningitis criteria included:

- 1) fever:
- 2) headache, stiff neck and/or other meningeal signs; and
- 3) CSF pleocytosis with predominant lymphocytes and/or elevated protein and a negative gram stain and culture). The sera were sequentially submitted to the laboratory, archived, and masked. The reference methods were CDC WNV IgG Capture ELISA, and plaque reduction neutralization test (PRNT) for West Nile virus.

Of 300 encephalitis/meningitis patients, 37 patients were classified as confirmed positive West Nile encephalitis patients (meningioencephalitis symptoms, CDC WNV IgG ELISA positive, and WNV PRNT positive), 210 patients had presumptive assay (CDC WNV IgG ELISA) results, and 53 patients were unclassified because the CDC WNV IgG ELISA results were indeterminant or equivocal. The Focus IgG ELISA was positive with 97.3% (36/37) of the confirmed positive WNV encephalitis patients (including 1 Focus equivocal calculated as negative). Of the 210 patients with presumptive assay results, 4 were classified as presumed positive flavivirus encephalitis patients (CDC WNV IgG positive, PRNT negative), one was classified as a confirmed dengue positive (CDC WNV IgG ELISA positive, dengue PRNT positive), and 205 were classified as presumed negative patients (CDC WNV IgG ELISA negative). The Focus IgG ELISA was positive with 100% (4/4) of the presumed positive WNV encephalitis patients, and positive with the one dengue positive patient. The Focus IgG ELISA was negative with 99.0% (203/205) of the presumed negative patients (including 1 Focus equivocal calculated as positive). The 53 unclassified patients were excluded from the calculations

Study Site 1: Focus Reactivity with Encephalitis/Meningitis Patients (n = 300)*

| Specimens Characterized by Reference Assays | | Focus WNV IgG ELISA Results | | | | |
|---------------------------------------------------------------------------------------------------------------|-----|-----------------------------|-----|-------|-----------------|------------|
| | Neg | Eqv | Pos | Total | % | 95%CI |
| Clinical sensitivity (encephalitis or /meningitis symptoms, CDC WNV IgG ELISA positive and WNV PRNT positive) | 0 | 1 | 36 | 37 | 97.3% (36/37) | 85.8-99.9% |
| Positive agreement with presumptive CDC WNV IgG ELISA † | 0 | 0 | 5 | 5 | 100% (5/5) | 47.8-100% |
| Negative agreement with presumptive CDC WNV IgG ELISA negative | 203 | 1 | 1 | 205 | 99.0% (203/205) | 96.5-99.9% |

*Excluding 53 CDC IgG ELISA results (49 indeterminant and 4 equivocal samples).

f One of the presumptive samples was dengue PRNT positive and the other 4 presumptive positives were negative with WNV, dengue and SLE PRNT.

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K031953

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### Performance Characteristics (continued)

### Study Site 2: Focus Reactivity with WNV PRNT Positives (n = 75)

A clinical laboratory located in the mid-western U.S. assessed the device's reactivity with 75 retrospective sere that were screened positive (by Focus) with a West Nile virus native antigen ELISA, and confirmed West Nile positive by plaque reduction neutralization test (PRNT). The sera were sequentially submitted to the laboratory, archived, The Focus IgG ELISA was positive with 36.0% (27/75) of the 75 PRNT positives (calculating 4 equivocals as negative), equivocal with four samples, and negative with 44 samples.

| Study Site 2: Focus Reactivity with WNV PRNT Positives (n = 75) | | | | | | |
|-----------------------------------------------------------------|-----------------------------|-----|-----|-------|---------------|------------|
| Specimens Characterized by Reference Assays | Focus WNV IgG ELISA Results | | | | | |
| | Neg | Eqv | Pos | Total | % | 95%CI |
| Serological sensitivity (WNV PRNT positive) | 44 | 4 | 27 | 75 | 36.0% (27/75) | 25.2-92.3% |

### Study Site 3: Focus Reactivity with West Nile IFA Negatives (n=157)

A clinical laboratory located in the southwestern U.S. assessed reactive West Nile IFA negative samples. The Focus IgG ELISA was 96.8% (152/157) negative with WNV IgG IFA negative samples (including two equivocals calculated as positive), and positive with three samples.

#### Study Site 3: Focus Reactivity with West Nile IFA Negatives (n=157)

| Specimens Characterized by Reference Assays | Focus WNV IgG ELISA Results | | | | | |
|---------------------------------------------|-----------------------------|-----|-----|-------|-----------------|------------|
| | Neg | Eqv | Pos | Total | % | 95% CI |
| Negative agreement with presumptive WNV IFA | 152 | 2 | 3 | 157 | 95.6% (152/157) | 91.1-98.2% |

### Study Site 4: Focus Reactivity with Suspected Encephalitis/Meningitis Patients (n = 50)

Focus assessed the device's reactivity with 50 sera from patients suspected of encephalitis/meningitis. A U.S. federal government laboratory provided the retrospective and masked sera. One sample was confirmed positive by West Nile PRNT, and the other 49 were presumptively negative (CDC ELISA) for arboviruses present in North America (LAC, EEE, SLE and WNV). The Focus IgG ELISA was negative with 95.6% (47/49) of the WNV negative samples, and positive with the one positive confirmed by West Nile PRNT .

### Study Site 4: Focus Reactivity with Suspected Encephalitis/Meningitis Patients (n = 50)

| Specimens Characterized by Reference Assays | Focus WNV IgG ELISA Results | | | | | |
|---------------------------------------------------------------------------|-----------------------------|-----|-----|-------|---------------|------------|
| | Neg | Eqv | Pos | Total | % | 95% CI |
| Serological sensitivity (CDC IgG ELISA positive and<br>WNV PRNT positive) | 0 | 0 | 1 | 1 | 100% (1/1) | NA |
| Negative agreement with presumptive CDC IgG ELISA | 47 | 0 | 2 | 49 | 95.9% (47/49) | 86.0-99.5% |

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K031953

#### 510(k) Summary of Safety and Effectiveness West Nile Virus ELISA IgG Catalog No. EL0300G Prepared October 17, 2003

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Performance Characteristics (continued)

Study Site 4: Focus Reactivity with Non-Flavivirus Test Samples (n = 476)

Focus assessed the device's reactivity with 476 samples prospectively collected from North America during August 2003. The samples had been submitted to a clinical laboratory located in Southern California for non-flavivirus tests (e.g., test for other infectious diseases). Positive samples were tested with a CDC West Nile IgG ELISA. The Focus West Nile ELISA IgG was negative with 96.8% (426/440) of the CDC ELISA negative samples (including 14 Focus equivocals calculated as positive), and was positive with 100% (21/21) of the CDC ELISA positive samples. Fifteen CDC ELISA IgG indeterminant samples were excluded from performance calculations.

### Study Site 4: Focus Reactivity with Non-Flavivirus Test Samples (n = 476)*

| Specimens Characterized by Reference Assays | Focus WNV IgG ELISA Results | | | | | |
|---------------------------------------------------|-----------------------------|-----|-----|-------|-----------------|------------|
| | Neg | Eqv | Pos | Total | % | 95% CI |
| Positive agreement with presumptive CDC IgG ELISA | 0 | 0 | 21 | 21 | 100% (21/21) | 83.9-100% |
| Negative agreement with presumptive CDC IgG ELISA | 426 | 14 | 0 | 440 | 96.8% (426/440) | 94.7-98.3% |

* Excludes 15 CDC IgG ELISA indeterminant samples.

### Focus Cross-reactivity

Focus (Study Site 4) and a state department of health laboratory located in the northeastern U.S. (DOH) (Study Site 1) assessed the device's cross-reactivity with sera that were sero-positive to other potentially cross-reactive pathogens (n = 75). The DOH tested the SLE positives, and Focus tested the other sera. The sera were archived and masked. The results of the study are summarized in the table below.

| Focus Cross-reactivity | | | | | | | |
|-----------------------------------------------|------|-----|-----|-----|-------|---------------|------------|
| Population | Site | Neg | Eqv | Pos | Total | % Positive | 95% CI |
| Dengue virus (secondary infections) | 4 | 1 | 0 | 19 | 20 | 95.0% (19/20) | 75.1-99.9% |
| Japanese encephalitis virus | 4 | 14 | 3 | 3 | 20 | 30.0% (6/20) | 11.9-54.3% |
| St. Louis encephalitis virus | 1 | 8 | 1 | 11 | 21 | 57.1% (12/21) | 34.0-78.2% |
| Yellow fever virus | 4 | 11 | 4 | 5 | 20 | 45.0% (9/20) | 23.1-68.5% |
| Alphavirus (Sindbis & Eastern equine viruses) | 4 | 15 | 0 | 2 | 17 | 11.8% (2/17) | 0.1-36.4% |
| Bunyavirus (Jamestown Canyon & La Crosse) | 1 | 12 | 2 | 1 | 15 | 20.0% (3/15) | 4.3-48.1% |
| Herpes simplex virus type 1 | 4 | 55 | 0 | 5 | 60 | 8.3% (5/60) | 2.8-18.4% |
| Epstein-Barr virus | 4 | 11 | 0 | 1 | 12 | 8.3% (1/12) | 0.2-38.5% |
| Cytomegalovirus | 4 | 16 | 0 | 4 | 20 | 20.0% (4/20) | 5.7-43.7% |
| Echovirus/Poliovirus | 4 | 18 | 1 | 1 | 20 | 10.0% (2/20) | 1.2-31.7% |
| Borrelia burgdorferi (Lyme disease) | 4 | 17 | 1 | 2 | 20 | 15.0% (3/20) | 3.2-37.9% |

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### Performance Characteristics (continued)

### Focus Sample Freeze-Thaw Study

Focus (Study Site 4) assessed the impact on the WNV IgG assay's reactivity by selecting 8 sera (5 positive and 3 negative), subjecting them to up to 5 repeated freeze-thaw cycles, and testing them in parallel with alluots that had not been frozen. There were no changes in interpretation in any of the sera. Positive samples in the IgM ELISA trended slightly towards increasing indices, while negative samples in the IgG ELISA did not appear to change indices.

#### Focus Reproducibility

Reproducibility studies included Inter-lot Reproducibility, InterlIntra-assay Reproducibility, and Inter-laboratory Reproducibility. In each study, two sets of samples were masked duplicates. Focus (Study Site 4) assessed the device's Inter-lot Reproducibility by testing five samples on 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 a different lot of Antigen and Capture Wells. Focus (Study Site 4) assessed the device's Inter/Intra-assay Reproducibility by testing seven samples in triplicate, once a day, for three days, for a total of 63 data points. A state department of health laboratory located in the northeastern U.S. (Study Site 1), and a clinical laboratory located in the mid-western U.S. (Study Site 2), Focus (Study .Site 4), assessed the device's Inter-laboratory Reproducibility. Each of the three laboratories tested seven samples in triplicate on three different days.

| Sample | Inter- & Intra-assay | | | Inter-lot | | Inter-Lab | |
|--------|----------------------|-----------------|-----------------|------------|-----------|------------|-----------|
| | Index Mean | Intra-assay %CV | Inter-assay %CV | Index Mean | Index %CV | Index Mean | Index %CV |
| G6* | 0.23 | 12.2 | 18.2 | 0.30 | 13.1 | 0.32 | 11.0 |
| G2* | 0.29 | 21.2 | 17.3 | 0.34 | 7.5 | 0.35 | 22.3 |
| G5 | 0.65 | 7.9 | 21.3 | 0.73 | 7.2 | 0.69 | 19.0 |
| G7* | 1.14 | 3.5 | 18.2 | 1.30 | 5.7 | 1.21 | 14.1 |
| G1* | 1.22 | 3.2 | 17.1 | 1.36 | 7.0 | 1.25 | 16.4 |
| G4 | 2.44 | 1.0 | 16.2 | 2.79 | 4.1 | 2.47 | 12.8 |
| G3 | 2.98 | 3.9 | 17.3 | 3.37 | 4.1 | 3.10 | 12.6 |

Foous Donroducibility

* There were two sets of masked pairs (same sample, different labeled identity): C2 & G6 were the second masked pair.

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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, 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.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 2 2003

Michael J. Wagner, Esq. Senior Regulatory Affairs Specialist Focus Technologies, Inc. 10703 Progress Way Cypress, CA 90630

Re: k031953

> Trade/Device Name: West Nile Virus ELISA IgG Regulation Number: 21 CFR 866.3940 Regulation Name: West Nile Virus Serological Reagents Regulatory Class: Class II Product Code: NOP Dated: October 17, 2003 Received: October 20, 2003

Dear Mr. Wagner:

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 Mav 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. Iisting 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 (OS) regulation (21 CFR Part 820).

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#### Page 2 -

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number (if known): K031953

Device Name:

West Nile Virus ELISA IgG

The Focus Technologies West Nile Virus ELISA IgG is intended Indications for Use: for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Soyattyns 10/21/03
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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(Optional Format 3-10-98)

510(k)K031953

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