IA #75-02, 7/14/05, IMPORT ALERT #75-02 "DETENTION WITHOUT PHYSICAL EXAMINATION AND
INCREASED SURVEILLANCE OF BLOOD GLUCOSE TEST STRIPS"
TYPE OF ALERT: Detention Without Physical Examination, Increased Surveillance
(Note: This import alert represents the Agency's current guidance
to FDA field personnel regarding the manufacturer(s) and/or
products(s) at issue. It does not create or confer any rights for
or on any person, and does not operate to bind FDA or the public).
PRODUCT: OneTouch Basic, OneTouch Profile, and OneTouch II blood glucose
test strips, manufactured by Lifescan, Inc., that are calibrated
to be "plasma equivalent.";
and
Accu-Chek blood glucose test strips, manufactured by Roche
Diagnostics Corporation, that are calibrated to be "whole blood
equivalent."
PRODUCT
CODE: 75CGA and 75LFR
PROBLEM: Adulterated and Misbranded
PAF: AAP Lack of an approved PMA; and
REG- Lack of a Premarket Notification, 510(k)
PAC FOR
COLLECTION: 82008
COUNTRY: All countries
MANUFACTURERS: ^
^
DISTRIBUTORS: Numerous
CHARGE: "These articles are subject to refusal of admission pursuant to
Section 801(a)(3) in that they are class III devices which do not
have an approved application for premarket approval in effect
pursuant to section 515(a) or an approved application for an
investigational device exemption under section 520(g).
[Adulterated, section 501(f)(1)(B)]"
and
"These articles are subject to refusal of admission pursuant to
section 801(a)(3) in that it appears that a notice or other
information respecting the devices was not provided to FDA, as
required by section 510(k), and the devices were not found to be
substantially equivalent to a predicate device. [Misbranded,
section 502(o)]"
OASIS CHARGE
CODE: LACK OF AN APPROVED APPLICATION FOR PREMARKET APPROVAL (PMA)
LACK OF A PREMARKET NOTIFICATION [510(k)]
RECOMMENDING
OFFICE: Center for Devices and Radiological Health (CDRH), Office of In
Vitro Diagnostic Device Evaluation and Safety (HFZ-440) and the
Office of Compliance (HFZ-320)
REASON FOR
ALERT: Lifescan manufactures, for export only, certain blood glucose test
strips that are calibrated to be "plasma equivalent." These
strips do not have FDA premarket clearance or approval. FDA
investigations revealed, however, that these test strips are being
imported into the United States by other companies.
Roche Diagnostics manufactures, for export only, certain blood
glucose test strips that are calibrated to be "whole blood
equivalent." These strips do not have FDA premarket clearance or
approval. FDA investigations revealed, however, that these test
strips are being imported into the United States by other
companies.
GUIDANCE: Districts may detain the following blood glucose test strips:
OneTouch Basic, OneTouch Profile, and OneTouch II strips,
manufactured by Lifescan that are calibrated to be plasma
equivalent. The outer carton packaging for these products ^
^. Plasma equivalent calibration may be confirmed in the
package inserts for the products. These products may also be
labeled as "not for sale in the United States" or with a similar
statement indicating that they are for export only and not to be
sold in the United States. In some cases, stickers may have been
placed over this designation.
Accu-Chek test strips, manufactured by Roche Diagnostics that are
calibrated to be whole blood equivalent. It is our understanding
that the outer carton packaging for these products ^
^. Whole blood equivalent
calibration may be confirmed in the package inserts for the
products. These products may also be labeled as "not for sale in
the United States" or with a similar statement indicating that
they are for export only and not to be sold in the United States.
In some cases, stickers may have been placed over this
designation.
Continued surveillance of blood glucose test strips from all
foreign shippers appears to be warranted.
Consult DIOP and the Center for Devices and Radiological Health
(HFZ-440), Tonya Wilbon at (240)276-0496 for questions concerning
whether detention is warranted.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact Division of Field Science at (301)276-0496.
PRIORITIZATION
GUIDANCE: N/A
FOI: Purging is required between ^ ^
KEYWORDS: Lifescan, Roche, blood glucose, test strips, plasma, whole blood
PREPARED BY: Tonya Wilbon, CDRH, OIVD (HFZ-440)
Anthony W. Lee, DIOP (HFC-170)
DATE LOADED
INTO FIARS: July 14, 2005
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