(281 days)
K 031899
Not Found
No
The device description and performance studies describe a traditional immunochromatographic assay, which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation. There are no mentions of AI, ML, or related technologies.
No.
This device is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and B viral nucleoprotein antigens, which aids in diagnosis rather than providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic immunochromatographic assay" and is "intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections."
No
The device description clearly outlines a physical test stick and associated reagents, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture.
Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.
Product codes (comma separated list FDA assigned to the subject device)
GNX
Device Description
The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal swab specimens
Indicated Patient Age Range
The study included pediatric subjects (2-19 years) and adults (> 20 years).
Intended User / Care Setting
The test is for use in clinical laboratories, health clinics, and physician office laboratories. The reproducibility study was conducted with nurses, nurse practitioners and physicians' office personnel.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Agreement with Viral Culture:
Study Type: Clinical comparison study against viral culture.
Sample Size: 383 subjects.
Key Results:
For Influenza A (n = 383):
Sensitivity: 73.8% (79/107) (95% CI 64.4% - 81.9%)
Specificity: 96.4% (266/276) (95% CI 93.4% - 98.2%)
Agreement: 90.1%
For Influenza B (n = 383):
Sensitivity: 60.0% (30/50) (95% CI 45.2-73.6%)
Specificity: 96.4% (321/333) (95% CI 93.8% - 98.1%)
Agreement: 91.6%
Assay Reproducibility:
Study Type: Reproducibility proficiency study.
Sample Size: Not explicitly stated as a single number, but involved multiple runs by three operators across three health centers and Genzyme Diagnostics. The table shows 156 total tests for overall accuracy.
Key Results:
Overall accuracy for Flu A: 97%
Overall accuracy for Flu B: 94%
Breakdown by sample type:
A - Strong Neg: 100.0% (12/12)
A - Low: 95.8% (23/24)
A - Med: 91.7% (11/12)
B - Strong Neg: 100.0% (12/12)
B - Low: 95.8% (23/24)
B - Med: 91.7% (11/12)
AB - Med: 100.0% (12/12)
Negative: 100.0% (48/48)
Total: 97.4% (152/156)
Analytical Specificity and Cross-reactivity:
Study Type: Evaluation with bacterial isolates and influenza virus strains.
Sample Size: 25 bacterial isolates, 46 human and animal influenza strains.
Key Results:
Bacterial Panel: Most bacterial isolates gave negative responses, except for "Very high levels of Staphylococcus aureus (>9x108 cfu/mL) produced a positive result." Cross-reactivity with other known respiratory viruses was not evaluated.
Influenza A/B Panel: All influenza virus isolates (46 human and animal strains) gave positive results with the test line at the expected location.
Analytical Sensitivity:
Study Type: Dilution study.
Key Results:
Approximate detection limits:
4.4 x 104 TCID50/test for influenza A (Kitakyushyu/159/93 (H3N2))
1.44 x 105 TCID50/test for influenza B (Lee/40)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For Influenza A:
Sensitivity: 73.8%
Specificity: 96.4%
For Influenza B:
Sensitivity: 60.0%
Specificity: 96.4%
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.
Quidel QuickVue™ Influenza A+B Test (K 031899)
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
§ 866.3328 Influenza virus antigen detection test system.
(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
0
OSOM Influenza A&B Test 510(k)
K 05/244
510(K) SUMMARY
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for the OSOM® Influenza A&B Test.
-
- Sponsor/Applicant Name and Address: Genzyme Corporation One Kendall Square Cambridge, MA 02139
-
- Sponsor Contact Information: Fred D. Lasky, Ph.D. Director, Regulatory Affairs Phone: 617.591.5512 FAX: 617.768.9592 Email: fred.lasky@genzyme.com
-
- Date of Preparation of 510(k) Summary: May 13, 2005
-
- Device Trade or Proprietary Name: OSOM Influenza A&B Test
- న్. Legally Marketed Devices to which Equivalence is Being Claimed: Quidel QuickVue™ Influenza A+B Test (K 031899)
1
6. Device Description:
Intended Use
The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C. viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture.
Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.
Principle of the Device
The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.
2
- Comparison of Technological Characteristics of Genzyme OSOM Influenza A&B Test 8. with Legally Marketed Device:
The similarities with, and differences between, the OSOM Influenza A&B Test and the Quidel QuickVue® Influenza A+B Test device are described in Table 1. Table 1: Summary of Device Similarities and Differences
| OSOM Influenza A&B Test | Quidel QuickVue® Influenza A+B Test | |
|---|---|---|
| Intended use | Intended for the qualitative | |
| detection of influenza A and | ||
| influenza B viral antigens | ||
| from nasal swab specimens. | ||
| It is intended to aid in the | ||
| rapid differential diagnosis of | ||
| influenza A and/or B viral | ||
| infections. The test is for use | ||
| in clinical laboratories, health | ||
| clinics, and physician office | ||
| laboratories. | Intended for the rapid, | |
| qualitative detection of | ||
| influenza type A and | ||
| influenza type B antigens | ||
| from nasal swab, nasal wash | ||
| and/or nasal aspirate | ||
| specimens. This test is | ||
| intended for use as an aid in | ||
| the rapid differential | ||
| diagnosis of acute influenza | ||
| type A and type B virus | ||
| infection. | ||
| Assay Format | Lateral flow immunoassay | Lateral flow immunoassay |
| Specimen | - nasal swabs | - nasal swabs |
- nasal wash
- nasal aspirate |
| Antibodies (labeled
and capture) | Mouse monoclonals | Mouse monoclonals |
| Conjugate | Colloidal gold | Latex |
| Objective Test Line | Pink to purple line | Red line |
| Internal Control | Yes -- red line | Yes – blue line |
| Time To Result | 10 minutes | 10 minutes |
3
Agreement with Viral Culture: 9.
The performance of the OSOM Influenza A&B Test was analyzed compared to viral culture for both influenza A and influenza B. Samples analyzed were from nasal swabs. The results of the comparison of the OSOM Influenza A&B Test are:
| Nasal Swab | ||
|---|---|---|
| Influenza A | ||
| (n = 383) | Influenza B | |
| (n = 383) | ||
| Sensitivity | 73.8% | 60.0% |
| Specificity | 96.4% | 96.4% |
| Agreement | 90.1% | 91.6% |
A total of 383 subjects were enrolled in the study. Of the 383 samples were from pediatric subjects (2-19 years) and 251 samples were from adults (> 20 years). The OSOM Influenza A&B Test was compared to cell culture to determine the comparative clinical sensitivity and clinical specificity for detection of influenza A and influenza B in nasal swab specimens.
| Flu A | |||
|---|---|---|---|
| OSOM | Culture | ||
| Influenza A&B | A+ | Negative | Total |
| A+ | 79 | 91 | 88 |
| A+B+ | 0 | 12 | 1 |
| Negative | 283 | 266 | 294 |
| Total | 107 | 276 | 383 |
Comparison of OSOM Influenza A&B Test to Cell culture: Nasal Swab
Clinical sensitivity: 73.8% (79/107)
(95% CI 64.4% - 81.9%)
Clinical specificity: 96.4%. (266/276)
(95% CI 93.4% - 98.2%)
4
Polymerase Chain Reaction (PCR) was performed on specimens that gave inconsistent results. This assay is not FDA approved or cleared. These results are provided for information only.
| PCR Results: | 1 5 Positive, 4 Negative | |
|---|---|---|
| 2 1 Negative | ||
| 3 24 Positive, 2 Negative, 1 B Positive, | ||
| 1 Quantity Not Sufficient (QNS) |
| Flu B | |||
|---|---|---|---|
| OSOM | |||
| Influenza | |||
| A&B | Culture | ||
| B+ | Negative | Total | |
| B+ | 30 | 114 | 41 |
| A+B+ | 0 | 15 | 1 |
| Negative | 206 | 321 | 341 |
| Total | 50 | 333 | 388 |
Clinical sensitivity: 60.0% (30/50)
(95% Cl 45.2-73.6%)
Clinical specificity: 96.4% (321/333)
(95% CI 93.8% - 98.1%)
Polymerase Chain Reaction (PCR) was performed on specimens that gave inconsistent results. This assay is not FDA approved or cleared. These results are provided for information only.
4 10 Positive, 1 Negative PCR Results: 5 1 Negative 6 19 Positive, 1 Negative
5
Assay Reproducibility
A reproducibility proficiency study was conducted to demonstrate that the OSOM Influenza A&B Test will perform acceptably in the hands of nurses, nurse practitioners and physicians' office personnel. A panel of swabs including negative (no virus), strong negative (below the limit of detection), low (near the limit of detection) and mid viral levels for influenza A and B were coded and masked to the operators. This study was conducted with three operators at three health centers in the eastern United States (2 physician's offices and 1 clinic site) and at Genzyme Diagnostics. The overall accuracy was 97% for flu A and 94% for flu B. Two invalid tests were considered as incorrect results in each analysis. We never saw the education level and experience of the testers, This is a CLIA waver labeling issue.
| | Correct
Response
for Flu A | | Lower 95%
Confidence
Interval | Upper 95%
Confidence
Interval |
|----------------|----------------------------------|--------|-------------------------------------|-------------------------------------|
| A - Strong Neg | 12/12 | 100.0% | 73.0% | 100.0% |
| A - Low | 23/24* | 95.8% | 78.9% | 99.9% |
| A - Med | 11/12* | 91.7% | 61.5% | 99.8% |
| B - Strong Neg | 12/12 | 100.0% | 73.0% | 100.0% |
| B - Low | 23/24 | 95.8% | 78.9% | 99.9% |
| B - Med | 11/12 | 91.7% | 61.5% | 99.8% |
| AB - Med | 12/12 | 100.0% | 73.0% | 100.0% |
| Negative | 48/48 | 100.0% | 92.5% | 100.0% |
| Total | 152/156* | 97.4% | 93.6% | 99.3% |
6
*invalids due to insufficient volume or no control line
Analytical Specificity and Cross-reactivity
The OSOM Influenza A&B Test was evaluated with 25 bacterial isolates. Bacterial isolates were tested at a concentration of approximately ... 108 cfu/mL.. Very high levels of Staphylococcus aureus (>9x108 cfu/mL) produced a positive result. All other bacteria listed gave negative responses. Cross-reactivity with other known respiratory viruses was not evaluated. Only influenza isolates were tested.
| Bacterial Panel: | |
|---|---|
| Acinetobacter calcoaceticus | tuberculosis |
| Bordetella pertussis | Neisseria meningitidis |
| Candida albicans | Proteus mirabilis |
| Corynebacterium diphteriae | Proteus vulgaris |
| Enterococcus faecalis | Pseudomonas aeruginosa |
| Enterococcus gallinarum | Serratia marcescens |
| Escherichia coli | Staphylococcus aureus |
| Haemophilus influenza | Staphylococcus epidermidis |
| Klebsiella pneumoniae | Streptococcus Group A |
| Legionella pneumophilia | Streptococcus Group B |
| Moraxella catarrhalis | Streptococcus mutans |
| Mycobacterium avium | Streptococcus pneumoniae |
| Mycobacterium | Torulopsis glabrata |
Influenza A/B Panel testing
A total of 46 human and animal influenza strains were tested with the OSOM Influenza A & B test. Viral titers (TCID50) for A/Kitakyushu/159/93 (H3N2) and B/Lee/40 were determined by inoculating MDCK cells, followed by standard procedures for cell culture viral assays. Aliquots of these controls with known TCID50 were then used to establish a standard curve in an ELISA assay. The concentrations of other influenza viruses were determined indirectly using the ELISA assay after the viruses had been inactivated. Influenza viruses were tested at an ELISA estimated TCID50 as listed in the table below.
All influenza virus isolates gave positive results with the test line at the expected location for the A, B and animal (positive for influenza A) isolates.
7
| Influenza A strains: | Sub-
type | Estimated
ELISA
TCID50/mL | Influenza B strains: | Sub-
type | Estimated
ELISA
TCID50/mL |
|------------------------|--------------|---------------------------------|----------------------------------|--------------|---------------------------------|
| Beijing/262/95 | H1N1 | 8.25E+07 | Ann Arbor/1/86 | | NA |
| Brazil/11/78 | H1N1 | NA | Beijing1/87 | | 1.04E+07 |
| Chile/1/83 | H1N1 | NA | Guangdong/120/200
0 | | 6.44E+07 |
| New Jersey/8/76 | H1N1 | 2.78E+08 | Hongkong/8/73 | | 1.74E+07 |
| Taiwan/1/86 | H1N1 | 3.47E+07 | Panama/45/90 | | 3.79E+07 |
| Guizhou/54/89 | H3N2 | 7.54E+07 | Singapore/222/79 | | 4.84E+07 |
| OMS/5389/88 | H3N2 | NA | Yamagata/16/88 | | 1.78E+07 |
| Beijing/32/92 | H3N2 | 3.97E+06 | Lee/40 | | 2.13E+08 |
| England/427/88 | H3N2 | 4.73E+07 | Mie/1/93 | | 4.84E+07 |
| Johannesburg/33/94 | H3N2 | 1.61E+07 | Guangdong/05/94 | | 1.27E+07 |
| Leningrad/360/86 | H3N2 | 2.50E+06 | Johannesburg/5/99 | | 5.87E+07 |
| Mississippi/1/85 | H3N2 | NA | Shandong/7/97 | | 4.41E+07 |
| Philippines/2/82 | H3N2 | 9.75E+07 | Shanghai/361/2002 | | NA |
| Shangdong/9/93 | H3N2 | 1.67E+08 | Animal
influenza strains: | Sub-
type | Estimated
ELISA
TCID50/mL |
| Shanghai/16/89 | H3N2 | 3.49E+08 | | | |
| Shanghai/24/90 | H3N2 | NA | | | |
| Sichuan/2/87 | H3N2 | NA | | | |
| Kitakyushyu/159/93 | H3N2 | 3.19E+08 | | | |
| Akita/1/94 | H3N2 | 2.90E+08 | | | |
| Beijing/262/95 | H1N1 | 1.71E+08 | | | |
| Yamagata/32/89 | H1N1 | 7.28E+07 | | | |
| New
Caledonia/20/99 | H1N1 | 6.86E+07 | | | |
| Panama/2007/99 | H3N2 | 1.40E+08 | A/Duck/Singapore-
Q/F119-3/97 | H5N3 | 1.65E+08 |
| Wyoming/03/03 | H3N2 | 7.40E+06 | A/Equine/Prague/56 | H7N7 | 5.37E+06 |
| Fujian/411/02 | H3N2 | 6.12E+07 | A/Duck/Wisconsin/1
120/82 | H5N3 | 2.30E+08 |
| | | | A/Hong
Kong/483/97 | H5N1 | 1.06E+08 |
| | | | A/Hong
Kong/213/2003 | H5N1 | 1.84E+08 |
| | | | A/Turkey/Ontario/71 | H7N3 | 8.12E+07 |
| | | | A/Mallard/Wisconsin/479/79 | H7N3 | 2.08E+08 |
| | | | A/Mallard/Saskatchewan/38/81 | H7N3 | 2.46E+08 |
Although this test has been shown to detect cultured avian influenza viruses, including avian influenza A subtype H5N1 virus, the performance characteristics of this test with specimens from humans infected with H5N1 or other avian influenza viruses are unknown
8
Interfering Substances
The following potential interferents were tested and were found to have no affect on the performance of the OSOM Influenza A&B Test.
| Potential Interferent | Concentration |
|---|---|
| Acetyl salicylic Acid | 20 mg/mL |
| Acetamidophenol | 10 mg/mL |
| Chlorpheniramine maleate | 5 mg/mL |
| Dextromethorphan HBr | 20 mg/mL |
| Diphenhydramine HCl | 5 mg/mL |
| Ephedrine HCl | 20 mg/mL |
| Guiacol Glyceryl Ether | 20 mg/mL |
| Oxymetazoline HCl | 10 mg/mL |
| Phenylephrine HCl | 100 mg/mL |
| Phenylpropanolamine | 20 mg/mL |
| Whole Blood | 2% |
| OTC Throat Drops | |
| Throat Drop (Halls) | 25% |
| Throat Drop (Zinc) | 25% |
| Throat Drop (Ricola) | 25% |
| OTC Nasal Sprays | |
| Nasal Spray (Zicam) | 10% |
| Nasal Spray (Afrin) | 10% |
| Nasal Spray (Vicks Sinex) | 10% |
Note: A very high hemoglobin concentration could interfere with the interpretation of the test result.
Analytical Sensitivity
Dilutions of influenza A Kitakyushyu/159/93 (H3N2) and for influenza B Lee/40 virus were run in triplicate on three lots of the OSOM Influenza A&B Test. The approximate detection limits of the OSOM Influenza A&B Test are 4.4 x 104 TCID50/test for influenza A and 1.44 x 105 TCID50/test for influenza B.
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three overlapping, curved lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the bird.
Public Health Service
ood and Drug Administrat 2098 Gaither Road Rockville MD 20850
FEB 2 1 2006
Fred D. Lasky, Ph.D Director of Regulatory Affairs Genzyme Corporation 500 Kendall Street Cambridge, MA 02142
Re: K051244
Trade/Device Name: OSOM® Influenza A&B Test Regulation Number: 21CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: February 13, 2006 Received: February 15, 2006
Dear Dr. Lasky:
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).
10
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sally, a story
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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genzyme
STATEMENT OF INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): KOSIZAY
OSOM® Influenza A&B Test Device Name: -------------
Indications For Use: k 051244
The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture.
Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.
AND/OR
Prescription Use >> (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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