- PerkinElmer Health Sciences, Inc.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
Promotional Unapproved Device for Domestic Warning Letter
VIA UNITED PARCEL SERVICE
OCT 23, 2014
Kay A. Taylor
VP of Global Regulatory, Quality and Clinical Affairs
940 Winter Street
Waltham, MA 02451
RE: Dried Blood Spot Card
Refer to CMS Case 407102 when replying to this letter.
Dear Ms. Taylor:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Dried Blood Spot Card in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of In Vitro
Diagnostics and Radiological Health (OIR) in the Center for Devices and Radiological Health reviewed your firm’s website, http://www.perkinelmer.comis
a device within the meaning of section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body. , which contains a link to PerkinElmer Labs/NTD’s website, http://www.ntdlabs.com
and your June 21, 2013 letter that you submitted as a follow up to a June 14, 2013 teleconference between FDA and your firm regarding the Dried Blood Spot Card. Based on this review, the Dried Blood Spot Card
You state in your June 21, 2013 letter that “[t]he First Trimester Screen | Fß LDT utilizes a dried blood spot sample collected using the Collection Device. The Collection Device is 510(k) cleared under k121864 and is manufactured and distributed by PerkinElmer Health Sciences, Inc. (the ‘Manufacturer’).” In other words, you indicate that the Dried Blood Spot Card is the Collection Device cleared under k121864. Although the PerkinElmer 226 Sample Collection Device (“Collection Device”) was cleared under k121864, its clearance was for the following intended use: “The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.” Notably, the device was cleared for use in “newborn screening,” not maternal screening. According to your June 21, 2013 letter, the Collection Device is intended for maternal screening. Specifically, the Collection Device is intended for use with the First Trimester Screen | Fß LDT, which is intended “to assess a mother’s risk for having a baby with Down syndrome, trisomy 18 and 13 in the first trimester of pregnancy.” Maternal screening constitutes a major change or modification in the intended use of the device under 21 CFR 807.81(a)(3)(ii).
In addition to your June 21, 2013 letter, statements on the websites identified above indicate that the Dried Blood Spot Card is intended to be used for maternal screening. Statements to that effect include, but are not limited to, the following:
- “PerkinElmer Labs/NTD's First Trimester Screen | Fß test reliably assesses a mother's risk for having a baby with Down syndrome, trisomy 18 and 13 in the first trimester of pregnancy. . . . A maternal dried blood spot sample is analyzed for two biochemical markers: free beta human chorionic gonadotropin (free beta hCG) and pregnancy associated plasma protein-A (PAPP-A). . . . The venous blood is immediately spotted onto a dried blood spot card provided by PerkinElmer Labs/NTD using a Diff-safe device or the blood is spotted directly from the finger.” (http://www.ntdlabs.com/maternal-marker-testing/first_trimester_screen.p…)
- Under “Patient FAQs” for First Trimester Screen | Fß: “Maternal blood specimens are spotted onto an absorbent filter paper using a simple finger stick method that can be performed in a physician’s office or in a testing lab, or at home by the patient using a home collection kit. No phlebotomist is required.” (http://www.ntdlabs.com/patients/patient_faq.php#)
- A training module on the Dried Blood Spot Card intended for patients refers to the Dried Blood Spot Card as the “First Trimester Screen | Fß with Instant Risk Assessment Down Syndrome Screening Collection Packet.” (http://www.ntdlabs.com/patients/dbsc_patients.php#)
- “PerkinElmer dried blood spot (DBS) kits* allow clinically effective and cost effective collection, transportation, testing and storage of patient samples, and have special value in expanding access to prenatal screening in regions where serum based prenatal screening is limited by geography. The method is widely used by NTD Laboratories, part of PerkinElmer, in providing first trimester screening services in the USA.” Although your website claims that the device is “[n]ot available in the USA,” PerkinElmer is offering the device for maternal screening in the U.S. through its subsidiary, PerkinElmer Labs/NTD. (http://www.perkinelmer.com/Catalog/Category/ID/Dried%20blood%20spot%20D…)
The Dried Blood Spot Card is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved application for investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). This device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
FDA requests that PerkinElmer, Inc. immediately cease activities that result in the misbranding or adulteration of the Dried Blood Spot Card, such as the commercial distribution of the device for the maternal screening uses discussed above.
Your firm should take prompt action to correct the violations described in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please submit a written response to this letter within 15 business days from the date you receive this letter containing specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which should address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Please direct your response to Ileana Elder at the Food and Drug Administration, 10903 New Hampshire Avenue, White Oak 66, Room 5632, Silver Spring, MD 20993, facsimile at (301) 847-8513. Refer to the identification number CMS 407102when replying. We remind you that only written communications are considered official. If you have any questions about contents of this letter, please contact Ileana Elder at (301) 796-6143.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure compliance with each applicable requirement of the Act and FDA implementing regulations.
Alberto Gutierrez, Ph.D.
Office of In Vitro Diagnostics and
Center for Devices and Radiological Health
PerkinElmer Lab/NTD is a subsidiary of PerkinElmer, Inc.
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