| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Document Mail Center - W066-0609 Silver Spring, MD 20993-0002 |
Department of Health and Human ServicesWARNING LETTER
MAR 18 2010
VIA FEDERAL EXPRESS
Paragon Dx, LLC
c/o Mr. Michael P. Murphy
President/CEO
133 Southcenter St Ste 200
Morrisville, NC 27560
Dear Mr. Murphy:
During an inspection of your firm located in Morrisville, NC on August 10 through 19, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following devices:
| Catalog No. | Gene/Allele | Description |
|---|---|---|
| A-003-02PB | CYP2C9*2 (Wild Type/Mutant) | ASR Probe Mix (5' FAM/F' CAL Fluor Orange 560) |
| A-003-03PB | CYP2C9*3 (Wild Type/Mutant) | ASR Probe Mix (5' Quasar 670/F' CAL Fluor Red 610) |
| A-004-173PB | VKORC1 1173 (Wild Type/Mutant) | ASR Probe Mix (5' FAM/F' CAL Fluor Orange 560) |
| A-004-3730PB | VKORC1 3730 (Wild Type/Mutant) | ASR Probe Mix (5" Quasar 670/F' CAL Fluor Red 610) |
Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
The inspection revealed that the referenced devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or approved applications for investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your products may be legally marketed.
It appears that you are marketing the above products as analyte specific reagents (ASRs). Most ASRs are classified as class I devices that do not require FDA premarket review. 21 CFR 864.4020(b)(1). However, your devices do not meet the definition of an ASR. ASRs are "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens." 21 CFR 864.4020(a). Moreover, ASRs are restricted from making "any statement regarding analytical or clinical performance." 21 CFR 809.30(d)(4). Your devices include several probes that must be used together to detect different genotypes rather than "an individual chemical substance or ligand." For additional information on the products FDA considers to be ASRs and products FDA does not consider to be ASRs, see Guidance for Industry and FDA Staff- Commercially Distributed Analyte Specific Reagents (ASRs):
Frequently Asked Questions.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: James Woods, Dupty Director PSPQ, 10903 New Hampshire Avenue, WO66 RM5688, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact: Rebecca Keenan at 301-796-6215 or 301-847-8513.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely yours,
/S/
Alberto Gutierrez, Ph.D.
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health
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