t2/26/2814 13:43 FAX 3A1 827 2857 CBER OBRR laao02/00L2 DI.PANTMENT Or IINALTH & trUMAFI SSRVTCES Public Heallh Setvice Food md Drug Admtnhf€ilon 1401 Roctryilb Plt(e Roekvillo, MD 2085A-1440 F.ebruary 24r2014 Mr. David Binks Arlington Scientific, Inc. 1840 North Technology Drive Springville, UT 84663 Re: TradelDsvice Narne: Regulation Name: Regulatory Clc$s; Produot Code: D*ted: Received: BKr3000l ASManager-AT Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use (21 CFR S62.?400) Class I JQT Fsbruary 24,2A14 February 24,zAI3 DearMr. Binks: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is zubstantially equivalent (forthg indications for use stated in the enclosuro) to legally marketed predicate aevicei markcted in interstate sommerce priorto May 28, l976,tha enactment dais of the Medical Device Amendments, orto dsvice$ that have bsen reclassified in accordance with the provisions of the Federal Food, Drug, Acf {the Alt) that do not require approval of a premarker approval application S-Cfry:*c (PMA)' You rnay, therefore, rnarkst the device, subjest to thi gnnoral conirots provislons of ttre Act Ths general controls provisions of the Act inplude requirJmonts for annual iigist*tion, Iisting of dwices, good manufasturing practice, labeling, and prohibitions against riisbrancing and adulteration. If your device is classified (see above) into either class II (Special Conrrols) or class III (pMA), may be subjeot to additional controls. Exi$ting major regulations affecting your device it can be found in the Code of Feder*l Regulations, Title 21, Parts gbO to 898. In addltion, FDA may publish further arnouncements concerning your device in the Federal Resister. Pl'ease be advised that FDA's issuance of a substantial equivalenoe determination does not mean that FDA has made'a detsrmination that your device complies with other requirements of the Act orary F{1al statutes and regulations administered by other Federal ugenci"r. you must comply with all of the Act's requirements, including, but not limited to: regisration and listing (21 CFR Part 807}; labeling (21 CFR Part 80I); medical device reporting (reporiing of medioal t2/28/20t4 13:43 FAX 301 827 2852 Page 2 -Mr. CNTR OBRR m 0003/00r2 Binfts device'rolated adverss evenf$) (21 cFR 803I good rnanufacturing practice requircments as set forth in the qualrty system$ (QS) regdarion(et cFR Parr Bz0); fid if applicable, the electronic product radiation control provisions ($ections 53t-S4zof rhs Ast); zi iFC i00;L;i,;;:--"-"'- If you dlsiry $ecifis ldvica for your device ojl our labeling regulation (z l CFR parr ggt ), please contact ths Division of Small Manufacturcrs, Internationatind*Coirsr*rr its tollfree number (s00) 63s-2041 or (301j796-7100 or at its Internet address arrio;;; Also, please note tho regulation entitled, "Misbranding by reference t" r;aifimtion, (Zl CFR part 807,97). For quesfioas rcgarding the roporting of adverse evsnts under tho rrabn regulation (21 CFR Part 803), please go to p*r**"t of $urveillance and BiometrieslDivision of for the CDRII's Office Fffi You may obtain other general infonnation on your responsibilities under the Act from the Divisicn of Smalt Manrrfacturers, Intemational and Consnmer Assistance at its toll-free number (800) 638-2041 or {3SL) 796-7100 or at its Internet address Sincerelyn ,){^;l-t A.4 Hira L. Nakhasi, phD Dirpctor Division of Emerging and Transfirsion Transmitted Diseases Office of Blood Researoh and Review Center for Biologics Evaluation and Research Enslosure A2/25/2814 13:43 FAX 301 827 2857 Page 3 CBER OBRR B oooa,zoor.z -Mr. Binks Indications for Uee Shtement 5r0{k) Number: BKt3000l Device Name: ASiManager-AT Indications for Use: The ASilv{anager-AT is intended to be used as an inregrmed digial particle analyzerto objectively interpret thc ASI RPR Card Test for Syphilis. nre asiUanago-nf is designedto prouiai stafldardizedtest interpretation and to provide for storage, r"t ieo*t, ana transmital ofth. ert results. It is intended to be acquired, possessed and used only by hsal*r .*tu p*er.i*Ar. 1'n ASi[4anager-AT is intended to be used for ix vitro diagrostics aoa Uooe aottor *r*iog. Prcscription Use _X_ {Part2l CFR 801 SubpartD) AllD/OR Over-The4ounter Usp {21 CFR 8Sl Subpart C) {PLEASE DO NOT WRITE BELOW THIS LINE.CO}ffiNUE ON ANOT}IER PAGE IF NEEDED} Concurrence of CBER, Office ofBlood Research and Division Sigtr-Otr Office ofglooa Research and Review Rwiew