
[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Rules and Regulations]
[Pages 56009-56011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22254]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2014-N-1251]


Medical Devices; Immunology and Microbiology Devices; 
Classification of Tryptase Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying tryptase 
test system devices into class II (special controls). The Agency is 
classifying the device into class II (special controls) because special 
controls, in addition to general controls, will provide a reasonable 
assurance of safety and effectiveness of the device.

DATES: This order is effective October 20, 2014. The classification was 
applicable February 15, 2012.

FOR FURTHER INFORMATION CONTACT: Elizabeth Stafford, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301-
796-6184.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the second procedure, rather than first submitting a premarket 
notification under section 510(k) and then a request for classification 
under the first procedure, the person determines that there is no 
legally marketed device upon which to base a determination of 
substantial equivalence and requests a classification under section 
513(f)(2) of the FD&C Act. If the person submits a request to classify 
the device under this second procedure, FDA may decline to undertake 
the classification request if FDA identifies a legally marketed device 
that could provide a reasonable basis for review of substantial 
equivalence with the device or if FDA determines that the device 
submitted is not of ``low-moderate risk'' or that general controls 
would be inadequate to control the risks and special controls to 
mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.

[[Page 56010]]

    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on January 3, 2012, classifying the ImmunoCAP Tryptase into class 
III, because it was not substantially equivalent to a device that was 
introduced or delivered for introduction into interstate commerce for 
commercial distribution before May 28, 1976, or a device which was 
subsequently reclassified into class I or class II. On January 12, 
2013, Phadia U.S., Inc. submitted a request for de novo classification 
of the ImmunoCAP Tryptase under section 513(f)(2) of the FD&C Act. The 
manufacturer recommended that the device be classified into class II.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request for de novo classification in order to classify the device 
under the criteria for classification set forth in section 513(a)(1). 
FDA classifies devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the request, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    The device is assigned the generic name tryptase test system, and 
it is identified as a device that aids in the diagnosis of systemic 
mastocytosis. It is intended for in vitro diagnostic use as an aid in 
the clinical diagnosis of patients with a suspicion of systemic 
mastocytosis in conjunction with other clinical and laboratory 
findings.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks 
in Table 1:

       Table 1--Identified Risks to Health and Mitigation Measures
------------------------------------------------------------------------
      Identified risks to health              Mitigation measures
------------------------------------------------------------------------
False negative result................  Device description containing the
                                        information specified in the
                                        special control guideline.
                                       Analytical performance
                                        validation.
                                       Software.
                                       Clinical performance evaluation.
                                       Labeling.
False positive result................  Device description containing the
                                        information specified in the
                                        special control guideline.
                                       Analytical performance
                                        validation.
                                       Software.
                                       Clinical performance evaluation.
                                       Labeling.
Inappropriate use....................  Labeling.
------------------------------------------------------------------------

    FDA believes that the measures set forth in the special controls 
guideline entitled ``Class II Special Controls Guideline: Tryptase Test 
System as an Aid in the Diagnosis of Systemic Mastocytosis'' are 
necessary, in addition to general controls, to mitigate the risks to 
health described in table 1.
    Therefore, on February 15, 2012, FDA issued an order to the 
petitioner classifying tryptase test system devices into class II. FDA 
is codifying this device type by adding Sec.  866.5760.
    Following the effective date of this final classification order, 
any firm submitting a 510(k) premarket notification for this device 
type will need to comply with the special controls.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this type of device is not exempt from premarket 
notification requirements. Persons who intend to market this type of 
device must submit to FDA a premarket notification, prior to marketing 
the device, which contains information about the tryptase test system 
they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously approved collections of information found in other 
FDA regulations. These collections of information are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in part 807, subpart E, regarding premarket notification 
submissions have been approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 801 and 21 CFR 809.10 have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  866.5760 to subpart F to read as follows:


Sec.  866.5760  Tryptase test system.

    (a) Identification. A tryptase test system is a device that aids in 
the diagnosis of systemic mastocytosis. It is intended for in vitro 
diagnostic use as an aid in the clinical diagnosis of patients with a 
suspicion of systemic mastocytosis in conjunction with other clinical 
and laboratory findings.

[[Page 56011]]

    (b) Classification. Class II (special controls). The special 
control is FDA's guideline entitled ``Class II Special Controls 
Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic 
Mastocytosis.'' For availability of the document, see Sec.  866.1(e).

    Dated: September 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22254 Filed 9-17-14; 8:45 am]
BILLING CODE 4164-01-P


