(254 days)
K#060099
Not Found
No
The device description and performance studies describe a standard immunochromatographic assay with visual result interpretation, not involving AI/ML.
No
The device is an in vitro diagnostic test used for the presumptive identification of Staphylococcus aureus, not for treating or monitoring a disease.
No
The "Intended Use" section explicitly states: "The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections."
No
The device description clearly states it is a "rapid immunochromatographic membrane assay" and is "mounted inside a cardboard, book-shaped hinged test device," indicating it is a physical, hardware-based test kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus." This clearly indicates it is used to test samples outside of the body to provide diagnostic information.
- Device Description: The description details a "rapid immunochromatographic membrane assay" that detects a specific protein from "blood culture samples." This further confirms it is a test performed on biological samples in a laboratory setting.
- Performance Studies: The document includes sections on "Clinical Performance," "Analytical Reactivity," "Analytical Specificity," "Interfering Substances," "Analytical Sensitivity," and "Reproducibility Study." These are all standard types of studies conducted to demonstrate the performance and reliability of an in vitro diagnostic device.
- Key Metrics: The inclusion of "Positive Agreement" and "Negative Agreement" (which are essentially sensitivity and specificity in this context) are key metrics used to evaluate the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" (K#060099 S. aureus PNA FISHTM) is common in regulatory submissions for IVDs, where a new device is compared to an already cleared device.
All of these elements strongly indicate that the BinaxNOW® Staphylococcus aureus Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
Product codes
JWX
Device Description
The BinaxNOW" Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sensitive polyclonal antibodies to detect a Staphylococcus aureus specific protein directly from blood cultures which have been identified as being positive for Gram-positive cocci in clusters. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device.
Specimens are aliquots from blood cultures which have been identified as positive for Gram-positive cocci in clusters. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.
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
Not Found
Intended User / Care Setting
Prescription Use
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)
The clinical performance of the BinaxNOW® Staphylococcus aureus Test was established in a multicenter clinical study conducted in 2008-09 at three geographically-diverse hospital laboratories within the US.
A total of 325 blood culture samples with Gram-positive cocci in clusters were evaluated at the three sites in the BinaxNOW® Staphylococcus aureus Test and compared to standard methods used routinely by the testing laboratories. The BinaxNOW® Staphylococcus aureus Test identified 98.8% of the specimens positive for Staphylococcus aureus and 100.0% of the specimens negative for Staphylococcus aureus relative to the reference method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement: 98.8% (95% C.I. 93.6 - 99.8%)
Negative Agreement: 100.0% (95% C.I. 98.4% - 100.0%)
Predicate Device(s)
S. aureus PNA FISHTM (AdvanDx) K#060099
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
2090964
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.
The assigned 510(k) number is 090964.
SUBMITTER
Binax, Inc. 10 Southgate Road Scarborough, Maine 04074 (207) 730-5733 (Office) (207) 730-5717 (FAX) Establishment Registration Number: 1221359
CONTACT PERSON
Suzanne Vogel suzanne.vogel@invmed.com (email)
DATE PREPARED
December 12, 2009
TRADE NAME BinaxNOW® Staphylococcus aureus Test
COMMON NAME
BinaxNOW® Staphylococcus aureus Test, BinaxNOW® Staphylococcus aureus, BinaxNOW® S. aureus, Binax NOW® Staphylococcus aureus Test, Binax NOW® Staphylococcus aureus, Binax NOW® S. aureus, NOW® Staphylococcus aureus Test. NOW® Staphylococcus aureus, NOW® S. aureus
CLASSIFICATION NAME
Microorganism differentiation and identification device (JWX) (per 21 CFR 866.2660)
PREDICATE DEVICE
S. aureus PNA FISHTM (AdvanDx) K#060099
DEVICE DESCRIPTION
The BinaxNOW" Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sensitive polyclonal antibodies to detect a Staphylococcus aureus specific protein directly from blood cultures which have been identified as being positive for Gram-positive cocci in clusters. These antibodies and a control antibody are immobilized onto a test strip as two distinct lines and combined with other reagents/pads. This test strip is mounted inside a cardboard, book-shaped hinged test device.
Specimens are aliquots from blood cultures which have been identified as positive for Gram-positive cocci in clusters. After the sample is prepared, it is added to the sample pad at the top of the test strip and the device is closed. Results are read at 10 minutes.
BinaxNOW® Staphylococcus aureus Test Confidential 510(k) Notification K090964 Rev. 12/09/09
Page 1 of 6
DEC 1 6 2009
1
INTENDED USE
The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW® Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
TECHNOLOGICAL CHARACTERISTICS
The BinaxNOW® Staphylococcus aureus Test is a rapid immunochromatographic membrane assay that uses highly sensitive polyclonal antibodies to detect a Staphylococcus aureus specific protein directly from blood cultures bottles positive for Gram-positive cocci in clusters.
PERFORMANCE SUMMARY
Clinical Performance
The clinical performance of the BinaxNOW® Staphylococcus aureus Test was established in a multicenter clinical study conducted in 2008-09 at three geographically-diverse hospital laboratories within the US.
A total of 325 blood culture samples with Gram-positive cocci in clusters were evaluated at the three sites in the BinaxNOW® Staphylococcus aureus Test and compared to standard methods used routinely by the testing laboratories. The BinaxNOW® Staphylococcus aureus Test identified 98.8% of the specimens positive for Staphylococcus aureus and 100.0% of the specimens negative for Staphylococcus aureus relative to the reference method.
| Reference Method | ||
|---|---|---|
| BinaxNOW® | ||
| Staphylococcus aureus | ||
| Test | Positive | Negative |
| Positive | 84 | 0 |
| Negative | 1 | 240 |
| 95% C.I. | ||
| Positive Agreement: | 98.8% | (93.6 - 99.8%) |
| Negative Agreement: | 100.0% | (98.4% - 100.0%) |
BinaxNOW® Staphylococcus aureus Test Compared to Reference Method
Expected Values
BinaxNOW® Staphylococcus aureus Test 510(k) Notification K090964 Rev. 12/09/09
Confidential
Page 2 of 6
2
In the external clinical evaluation of BinaxNOW® Staphylococcus aureus Test, the overall expected rate of S. aureus in blood culture was 26.2% (85/325), and among the three site populations the expected positive rate ranged from 16.9% to 41.5%.
Analytical Reactivity
The 54 human pathogenic Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) and American Type Culture Collection (ATCC) Staphylococcus aureus strains listed below tested positive in the BinaxNOW® test.
| Staphylococcus aureus strains | |
|---|---|
| Bacterium | Bacterium |
| Staphylococcus aureus ATCC 13150 | Staphylococcus aureus NRS172 |
| Staphylococcus aureus ATCC 11632 | Staphylococcus aureus NRS241 |
| Staphylococcus aureus ATCC 14776 | Staphylococcus aureus NRS245 |
| Staphylococcus aureus ATCC 14458 | Staphylococcus aureus NRS248 |
| Staphylococcus aureus ATCC 6517 | Staphylococcus aureus NRS249 |
| Staphylococcus aureus ATCC 29737 | Staphylococcus aureus NRS164 |
| Staphylococcus aureus ATCC 29213 | Staphylococcus aureus NRS165 |
| Staphylococcus aureus ATCC 49476 | Staphylococcus aureus NRS166 |
| Staphylococcus aureus ATCC 33592 | Staphylococcus aureus NRS167 |
| Staphylococcus aureus ATCC BAA38 | Staphylococcus aureus NRS168 |
| Staphylococcus aureus ATCC 14775 | Staphylococcus aureus NRS169 |
| Staphylococcus aureus ATCC BAA43 | Staphylococcus aureus NRS170 |
| Staphylococcus aureus Lafferty | Staphylococcus aureus NRS171 |
| Staphylococcus aureus ATCC 6538P | Staphylococcus aureus NRS173 |
| Staphylococcus aureus ATCC BAA1026 | Staphylococcus aureus NRS174 |
| Staphylococcus aureus ATCC BAA977 | Staphylococcus aureus NRS175 |
| Staphylococcus aureus ATCC BAA39 | Staphylococcus aureus NRS176 |
| Staphylococcus aureus ATCC51153 | Staphylococcus aureus NRS177 |
| Staphylococcus aureus ATCC 700789 | Staphylococcus aureus NRS382 (USA100) |
| Staphylococcus aureus ATCC BAA41 | Staphylococcus aureus NRS383 (USA200) |
| Staphylococcus aureus ATCC 33591 | Staphylococcus aureus NRS384 (USA300) |
| Staphylococcus aureus ATCC BAA44 | Staphylococcus aureus NRS123 (USA400) |
| Staphylococcus aureus ATCC 700698 | Staphylococcus aureus NRS385 (USA500) |
| Staphylococcus aureus ATCC 43300 | Staphylococcus aureus NRS22 (USA600) |
| Staphylococcus aureus ATCC 700699 | Staphylococcus aureus NRS386 (USA700) |
| Staphylococcus aureus NRS193 | Staphylococcus aureus NRS387 (USA800) |
| Staphylococcus aureus NRS194 | Staphylococcus aureus NRS192 |
Stanhulococcus aureus strains
Analytical Specificity (Cross-Reactivity)
To determine the analytical specificity of the BinaxNOW® Staphylococcus aureus Test, coagulasenegative Staphylococcus strains, yeasts and non-staphylococcal strains were tested in the BinaxNOW® Test. All strains in the tables below tested negative.
| Bacterium |
|---|
| Staphylococcus auricularis ATCC 33753 |
BinaxNOW® Staphylococcus aureus Test Confidential 510(k) Notification K090964 Rev. 12/09/09
Page 3 of 6
. .
3
| Staphylococcus capitis ATCC 35661 |
|---|
| Staphylococcus caprae ATCC 51548 |
| Staphylococcus cohnii ATCC 29972 |
| Staphylococcus delphini ATCC 49171 |
| Staphylococcus epidermidis ATCC 700579 |
| Staphylococcus haemolyticus ATCC 29970 |
| Staphylococcus hominis ATCC 27844 |
| Staphylococcus hyicus ATCC 11249 |
| Staphylococcus intermedius ATCC 29663 |
| Staphylococcus kloosii ATCC 43959 |
| Staphylococcus lentus ATCC 700403 |
| Staphylococcus lugdunensis ATCC 43809 |
| Staphylococcus lutrae ATCC 700373 |
| Staphylococcus pasteuri ATCC 51128 |
| Staphylococcus pseudintermedius ATCC 49444 |
| Staphylococcus pulvereri ATCC 51698 |
| Staphylococcus saprophyticus ATCC 35552 |
| Staphylococcus schleiferi ATCC 43808 |
| Staphylococcus sciuri ATCC 49575 |
| Staphylococcus stimulans ATCC 27851 |
| Staphylococcus vitulinus ATCC 51162 |
| Staphylococcus warneri ATCC 49454 |
| Staphylococcus xylosus ATCC 49148 |
Non- Staphylococcal Strains
| Non-Staphylococcal Strains | |
|---|---|
| Bacterium | Bacterium |
| Acinetobacter calcoaceticus ATCC 51432 | Pasteurella multocida ATCC 51687 |
| Aerococcus urinae ATCC 700306 | Pediococcus acidilactici ATCC 12697 |
| Aerococcus viridans ATCC 10400 | Peptostreptococcus anaerobius ATCC 27337 |
| Aeromonas hydrophilia ATCC 35654 | Planococcus citreus ATCC 14404 |
| Bacillus cereus ATCC 11778 | Proteus mirabilis ATCC 7002 |
| Bacillus subtilis ATCC 6633 | Proteus vulgaris ATCC 33420 |
| Bacteroides fragilis ATCC 23745 | Providencia stuartii ATCC 49809 |
| Beta strep group F ATCC 12392 | Pseudomonas aeruginosa ATCC 15442 |
| Burkholdaria cepacia ATCC 25416-T | Pseudomonas fluorescens ATCC 49271 |
| Citrobacter freundii ATCC 8090 | Pseudomonas putida ATCC 49128 |
| Clostridium septicum ATCC 12646 | Rhodococcus equi ATCC 10146 |
| Clostridium sordelli ATCC 9714 | Salmonella adelaide ATCC 10718 |
| Corynebacterium amycolatum ATCC 49368 | Serratia marcescens ATCC 13880 |
| Corynebacterium diphtheriae ATCC 13812 | Stenotrophomonas maltophilia ATCC 13637-T |
| Corynebacterium glutamicum ATCC 13869 | Stomatococcus (Rothia mucilaginosa) ATCC 25296 |
| Corynebacterium jeikeium ATCC 43734 | Stomatococcus (Rothia mucilaginosa) ATCC 49040 |
| Corynebacterium pseudodiptheriticum ATCC 10700-T | |
| Stomatococcus (Rothia mucilaginosa) ATCC 49041 | |
| Corynebacterium urealyticum ATCC 43042 | Stomatococcus (Rothia mucilaginosa) ATCC 49042 |
| Corynebacterium xerosus ATCC 7711 | Streptococcus agalactiae (Beta Strep Group B) ATCC 13813 |
BinaxNOW® Staphylococcus aureus Test
510(k) Notification K090964
Rev. 12/09/09
.
Confidential
4
| Enterobacter aerogenes ATCC 35029 | Streptococcus anginosis (milleri) ATCC 33397 |
|---|---|
| Enterobacter cloacae ATCC 49141 | Streptococcus dysgalactiae (Group C) ATCC 12388 |
| Enterococcus avium ATCC 49462 | Streptococcus dysgalactiae (Group G) ATCC 12394 |
| Enterococcus casseliflavus ATCC 12817 | Streptococcus intermedius (milleri) ATCC 27355 |
| Enterococcus durans ATCC 49135 | Streptococcus mitis ATCC 49456 |
| Enterococcus faecalis ATCC 49474 | Streptococcus mutans ATCC 25175 |
| Enterococcus faecium ATCC 12952 | Streptococcus pasteurans (bovis) ATCC 49133 |
| Enterococcus gallinarum ATCC 49608 | Streptococcus pneumoniae ATCC 33400 |
| Enterococcus hirae ATCC 10541 | Streptococcus pneumoniae ATCC 39938 |
| Enterococcus mundtii ATCC 43187 | Streptococcus pneumoniae ATCC 49136 |
| Enterococcus raffinosus ATCC 49464 | Streptococcus pneumoniae ATCC 49619 |
| Escherichia coli ATCC 10798 | Streptococcus pneumoniae ATCC 51937 |
| Gemella spp. bergeri ATCC 700627 | Streptococcus pneumoniae ATCC 51938 |
| Haemophilus influenzae ATCC 49247 | Streptococcus pneumoniae ATCC 6301 |
| Klebsiella oxytoca ATCC 49131 | Streptococcus pneumoniae ATCC SSI-1 |
| Klebsiella pneumoniae ATCC 49472 | Streptococcus pneumoniae ATCC SSI-10A |
| Lactobacillus casei ATCC 393 | Streptococcus pneumoniae ATCC SSI-14 |
| Lactococcus spp.garvieae ATCC 49157 | Streptococcus pneumoniae ATCC SSI-7F |
| Leuconostoc mesenteriodes ATCC 10877 | Streptococcus pyogenes, group A ATCC 12384 |
| Listeria monocytogenes ATCC 19115 | Streptococcus salivarius ATCC 13419 |
| Macrococcus caseolyticus (formerly Staph cohnii subsp. cohnii) ATCC 35662 | Streptococcus salivarius ATCC 13419 |
| Micrococcus luteus ATCC 27141 | Yeasts |
| Moraxella catarrhalis ATCC 25238 | Candida albicans ATCC 60193 |
| Morganella morganii ATCC 25830-T | Candida glabrata ATCC 66032 |
| Neisseria meningitides (serogroup A) ATCC 13077 | Candida tropicalis ATCC 750 |
| Neisseria sicca ATCC 9913 |
Interfering Substances:
None of the 20 potentially interfering substances listed below produced false results in the BinaxNOW® Staphylococcus aureus test.
. . . . . .
.
| Anti-Inflammatory
| Drugs | Test Concentration | Endogenous Blood Components | Test Concentration |
|---|---|---|---|
| Acetaminophen | $1324 \mu mol/L$ | Hemoglobin | 2 g/L |
| Acetylsalicyclic acid | 3.62 mmol/L | Triglyceride sera | 37 mmol/L |
| Ibuprofen | $2425 \mu mol/L$ | Conjugated bilirubin | $342 \mu mol/L$ |
| Antibiotics | Test Concentration | Unconjugated bilirubin | $342 \mu mol/L$ |
| Amoxicillin | $206 \mu mol/L$ | $\gamma$ - globulin | 120g/L |
| Cephalexin | $337 \mu mol/L$ | Anti-coagulant | Test Concentration |
| Chloramphenicol | $155 \mu mol/L$ | Sodium Polyanetholesulfonate (SPS) | 1% |
| Ciprofloxacin | $30.2 \mu mol/L$ | ||
| Erythromycin | $81.6 \mu mol/L$ | ||
| Gentamicin | $21 \mu mol/L$ |
5
| Tetracycline | 34 $ $\mu$ $ mol/L |
|---|---|
| Sulfisoxazole | 1.12 mmol/L |
| Sulfamethoxazole | 1.58 mmol/L |
| Trimethoprim | 138 $ $\mu$ $ mol/L |
| Vancomycin | 69 $ $\mu$ $ mol/L |
Analytical Sensitivity:
The analytical limit of detection of the BinaxNOW® Staphylococcus aureus Test is 5.42 x 10° cells/mL.
| Bacterial
Concentration
cells/mL | Number
Detected | %
Detection |
|----------------------------------------|--------------------|----------------|
| $2.71 \times 10^9$ | 26/26 | 100 |
| $5.42 \times 10^8$ | 25/26 | 96 |
| $1.14 \times 10^8$ | 15/26 | 75 |
| $7.07 \times 10^7$ | 10/26 | 50 |
Reproducibility Study:
A study of the BinaxNOW® Staphylococcus aureus Test was conducted at 3 separate sites using panels of blind coded specimens containing negative and positive samples. Participants tested each sample twice on 5 different days. There was 98% (588/600) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (5 different days), between sites (3 sites), or between operators (6 operators).
Signed Angela Drysdale Clinical Affairs Binax, Inc.
Date
BinaxNOW® Staphylococcus aureus Test 510(k) Notification K090964 Rev. 12/09/09
Confidential
Page 6 of 6
6
Image /page/6/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top of the circle. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC 1 6 2009
Binax, Inc. c/o Ms. Suzanne Vogel Clinical Affairs Inverness Medical 10 Southgate Road Scarborough, ME 04074
Re: K090964
Trade Name: BinaxNow® Staphylococcus Aureus Test Regulation Number: 21 CFR §866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class I Product Codes: JWX Dated: October 23, 2009 Received: October 30, 2009
Dear Ms. Vogel:
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
7
Enclosure
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).
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,
Souza Atomo
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
8
ATTACHMENT 14: INDICATIONS FOR USE FORM
510(k) Number: 090964
Device Name: BinaxNOW® Staphylococcus aureus Test
Indications for Use:
The BinaxNOW® Staphylococcus aureus Test is a qualitative, in vitro immunochromatographic assay for the presumptive identification of Staphylococcus aureus. The test is performed directly on blood culture samples positive for Gram-positive cocci in clusters. The BinaxNOW Staphylococcus aureus Test is not intended to diagnose Staphylococcus aureus nor to guide or monitor treatment for Staphylococcus aureus infections. Subculturing positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie U. Rocke
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K090964
BinaxNOW® Staphylococcus aureus Test Confidential 510(k) Notification K090964 Rev. 12/09/09