Letter to Nanogen Corporation
Via Federal Express
August 11, 2005
David Ludvigson
President and Chief Operating Officer
Nanogen Corporation
10398 Pacific Center Ct.
San Diego, California 92121
Dear Mr. Ludvigson:
The Office of In Vitro Diagnostic Devices (OIVD) has reviewed information
on the Nanogen Corporation Internet website, http://www.nanogen.com/products,
about the NanoChip® Molecular Biology Workstation, NanoChip®
Electronic Microarray and several devices marketed as analyte specific
reagents (ASRs).
Nanogen describes the NanoChip® Molecular Biology Workstation
as "an automated multipurpose instrument that facilitates detection
of known sequences, such as in the analysis of Single Nucleotide
Polymorphisms (SNPs) and Short Tandem Repeats (STRs) using the NanoChip
Electronic Microarray.” Nanogen states that the Workstation
is a fully integrated system consisting of “three major subsystems:
(1) the NanoChip® Loader for loading patient samples on one
to four NanoChip Cartridges, (2) the NanoChip® Reader, a highly
sensitive, laser-based fluorescence scanner for detection of assay
results and (3) computer hardware and software which automates imports,
analysis and export of sample information making data analysis simple.”
Nanogen describes its NanoChip Electronic Microarray, which is
intended to be used with the Workstation, as an "electronic
microarray contain[ing] 100 test sites laid out in a geometric grid.
Each test site can be controlled electronically from the system's
onboard computer." Nanogen states that "Current applications
performed on the NanoChip array include single nucleotide polymorphisms
(SNPs), short tandem repeats (STRs), insertion, deletion, and other
mutation analyses. Each of these is a genetic marker used in cutting-edge
clinical research and clinical diagnostics."
(emphasis added).
Nanogen's website indicates that it offers reagents "predefined"
for use with the NanoChip Molecular Biology Workstation, including
an ApoE device, ASPA device, HFE device, and FactorV/Prothrombin
device. Your website contains statements representing that these
products are ASRs.
The workstation, microarray, and ASRs appear from the information
on your website to be marketed to work together as an integrated
test system. It appears the NanoChip Electronic Microarray and the
"predefined" ASRs promoted on your web site must be read
by the NanoChip Molecular Biology Workstation. This test system
is a medical device under section 201(h) of the Federal Food, Drug,
and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it
is intended for use in the diagnosis of disease or other conditions.
A review of our records indicates that you have not obtained clearance
or approval for this test system as a whole or for the components
separately.
Contradictory statements in some Nanogen representations suggest
that these products are intended for research use, while others
indicate that they are intended for use in clinical diagnostic applications
(i.e., see above). On the website, Nanogen materials for both the
NanoChip and the Workstation indicate that each product is "For
laboratory use only." The "Legal Notices" section
of Nanogen's website states:
The NanoChip System is a general purpose instrument and an open
platform that allows the user to select his or her own application.
No particular research application has been approved by the U.S.
Food and Drug Administration for diagnostic purposes. The
NanoChip System is designed for laboratory use only which means
that it may be used for either research purposes or by high complexity
CLIA certified laboratories and not for any other purposes. While
user may use the NanoChip System to help further understand the
relevance of a particular gene or genes of interest, it may not
be used for specific disease diagnosis other than as described
above and no claim or representation for such clinical use whatsoever
is made by Nanogen for the system. User shall certify that it
will use system only for either research purposes only or that
it is a high complexity CLIA certified laboratory by signing any
certification letter reasonably requested by Nanogen.
(emphasis in original).
While Nanogen thus appears to be suggesting that its NanoChip System
comprises research-use only devices, it is not apparent that Nanogen
is complying with the requirement applicable to research-use only
in vitro diagnostic devices, as set forth in 21 CFR 809.10(c)(2)(i),
that require the labeling for such devices bear the statement, "For
Research Use Only. Not for use in diagnostic procedures." Moreover,
Nanogen's own materials indicate that the NanoChip system is intended
to be used for diagnostic purposes. As already noted, the materials
regarding the NanoChip Microarray indicate that the testing it performs
is used in "cutting-edge . . . clinical diagnostics."
The Workstation is described as permitting users "to define,
select and build their own test panels or select from predefined
ASRs." Clicking the highlighted term "predefined ASRs"
links readers to information on several specific products which
are represented as being analyte specific reagents within the meaning
of 21 CFR 864.4020, a classification for reagents used by laboratories
to develop in-house diagnostic testing. Finally, Nanogen's "legal
notice" indicates that the NanoChip system is intended for
diagnostic use by high-complexity CLIA certified laboratories.
Manufacturers of medical devices, even if they market their products
solely to CLIA certified laboratories, are required to have FDA
premarket approval or clearance for their devices unless the devices
are classified as class I and exempt from premarket notification.
Your test system does not appear to be a device that has been classified
class I and exempt from premarket notification. The test system
is therefore adulterated under section 501(f)(1)(B) of the Act for
failure to obtain premarket approval and misbranded under section
502(o) of the Act for failure to notify the agency of your intent
to introduce the device into commercial distribution as required
by section 510(k) of the Act. For products requiring premarket approval,
the notification required by section 510(k) is deemed to be satisfied
when a premarket approval application is pending before the Agency.
21 CFR § 807.81(b).
We request that you respond within thirty (30) days of receipt
of this letter. You may indicate in your response if you would like
to meet with us at your earliest convenience to discuss the NanoChip®
Molecular Biology Workstation, NanoChip® Electronic Microarray
and your devices marketed as ASRs.
Please direct your response to James Woods, Deputy Director of
Patient Safety and Product Quality, Office of In Vitro Diagnostic
Device Evaluation and Safety, 2098 Gaither Road, HFZ-440, Rockville,
Maryland 20850.
Sincerely,
Steven I. Gutman, M.D., M.B.A.
Director
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
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