UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

 

Date of report (Date of earliest event reported)  July 11, 2016

 

Accelerate Diagnostics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

 

001-31822  84-1072256
(Commission File Number)  (IRS Employer Identification No.)

 

3950 South Country Club, Suite 470, Tucson, Arizona  85714
(Address of principal executive offices)  (Zip Code)

 

(520) 365-3100

(Registrant’s telephone number, including area code)

 

 

 

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

Item 8.01.Other Events.

 

On July 11, 2016, Accelerate Diagnostics, Inc. issued a press release announcing the submission of a De Novo request for Evaluation of Automatic Class III Designation to the U.S. Food and Drug Administration (FDA) for its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for positive blood culture samples.  A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01Financial Statements and Exhibits.

 

(d)           Exhibits.  The following material is filed as an exhibit to this Current Report on Form 8-K:

 

Exhibit  
Number Description                                                                 
   
99.1

Press Release, July 11, 2016 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Date: July 11, 2016 ACCELERATE DIAGNOSTICS, INC.  
  (Registrant)  
     
  /s/ Steve Reichling  
  Steve Reichling  
  Chief Financial Officer  

 

 

 

 

EXHIBIT INDEX

 

Exhibit  
Number Description                                                                 
   
99.1

Press Release, July 11, 2016