Arrayit Corporation (ARYC)

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510(k) Clearance to Market:

The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.

Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.

http://www.qrasupport.com/FDA_MED_DEVICE.html



Arrayit Blood Card technology has been developed for research, veterinary and pathology purposes. Extreme care and exact attention should be practiced in the use of these products. Arrayit Blood Cards and Blood Card Kits are manufacturing using the highest industry standards and are subjected to extensive quality control and quality assurance prior to shipping. These products are guaranteed to perform as described when used according to instructions. Blood card technology is pending 510(k) submission and is not to be used for in vitro diagnostics prior to FDA approval. Arrayit assumes no liability for improper use of these products and our liability is limited to product replacement only. Any misuse of this product is the full responsibility of the customer, and Arrayit makes no warranty or guarantee under such circumstances. The customer agrees to wear nitrile gloves and safety glasses at all times when using the DNA and RNA Isolation Kits.

http://arrayit.com/Microarray_Diagnostics/Blood_Cards/blood_cards.html


Arrayit advanced blood cards allow collection, fractionation, sampling, shipping and storage with a single blood card. Separates whole blood into red blood cells, white blood cells and serum components in 5 minutes using unique linear separation chromotography for research, veterinary and in vitro diagnostic applications including genotyping, mRNA expression and protein profiling. Each kit contains a Blood Card and an anti-static shipping envelope. Cards are labeled with a traditional barcode containing a serial numeric, two-dimensional QR Code for mobile device access and a patient ID for unique sample identification. This product is offered for research use only pending 510(k) approval by the FDA. Pricing is per card.

http://arrayit.com/Microarray_Diagnostics/Blood_Cards/blood_cards.html




OvaDx® Blood Cards. Patient samples for OvaDx® diagnostic testing can be submitted using Arrayit Corporation blood cards. Place 5 large drops of fresh patient blood inside the red box of a new card. Arrayit’s unique competitive linear transfer chromotography technology partitions the whole blood components from left to right such that the serum containing the OvaDx® biomarkers separates cleanly from the red blood cells in 1 minute. Please allow the card to dry for 10 minutes prior to mailing. Dried cards should be placed in the airtight mailing envelopes supplied with the sampling kit and mailed to our Sunnyvale laboratories for testing.

http://arrayit.com/Microarray_Diagnostics/OvaDx_Ovarian_Cancer_Test/ovadx_ovarian_cancer_test.html



Quantitation & analysis software:

Arrayit offers the world’s only next generation microarray scanning technology, with proprietary rotary motion control, dynamic auto-focusing, 2-color fluorescence detection, 0.5 µm scan resolution, 3 minute scan times, 24-substrate slide autoloader option and complete MAPIX® software

Quantitation and analysis software is included with every scanner. Mapix® is a microarray image analysis software application that is both intuitive and easy to use, combining imaging and analysis tools for superior performance. Highly efficient algorithms provide rapid and effective feature gridding through automatic spot searching and optimal grid alignment.

http://arrayit.com/Products/Microarray_Scanners/Microarray_Scanner/Microarray-Scanners/microarray-scanners.html



Arrayit Corporation Ships Clinical Instrumentation and Software to the United States Food and Drug Administration

Sunnyvale, Sept. 24, 2018 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, reports the shipment of clinical instrumentation and quantification software to the United States Food and Drug Administration (FDA). Arrayit uses the same instrumentation and software to test for allergy and food intolerance as well as pipeline indications for ovarian cancer and Parkinson’s Disease (PD). Testing is performed in the company’s Clinical Laboratory Improvement Amendments (CLIA) laboratory licensed by the California Department of Public Health (CDPH) and the Center for Medicare and Medicaid Services (CMS).

https://www.yahoo.com/amphtml/finance/news/arrayit-corporation-ships-clinical-instrumentation-093000351.html


Arrayit’s company tweet regarding the FDA submission:

Arrayit provides 7/2/18 FDA update: (1) excellent meeting, (2) large attendance by FDA top brass, (3) insightful and instructive, (4) our entire clinical team wishes to thank the agency for their feedback and generosity, and (5) we believe that our test will receive FDA approval.