DEVICE: Sensonics Microencapsulated Smell Tests (G051SITT0)

Device Identifier (DI) Information

Sensonics Microencapsulated Smell Tests
SITT
In Commercial Distribution

Sensonics, Inc.
G051SITT0
HIBCC

1
107213563 *Terms of Use
Until the development of the Smell Identification Test™, also known as the University of Pennsylvania Smell Identification Test (UPSIT), no convenient means for subjectively assessing smell function was generally available. By incorporating microencapsulation technology and sound psychometric principles into a simple test format, the Smell Identification Test™ filled this void. Although this test was initially designed to provide only a first-step olfactory “screening” function, it became quite clear early on that the test was much more broadly useful than first envisioned and had applicability in numerous clinical, laboratory, and industrial settings. Indeed, the Smell Identification Test™ was found to be more reliable and to correlate more closely in the clinical setting with patient complaints and other indices of dysfunction than more traditional threshold and suprathreshold psychophysical methods. The Smell Identification Test consists of four envelope-sized booklets, each containing ten “scratch & sniff ” odorants. The odorants are embedded in 10- to 50-um urea-formaldehyde polymer microencap- sules fixed in a proprietary binder and positioned on brown strips at the bottom of the test booklets. The stimuli are released by scratching strips with a pencil tip in a standardized manner. Above each odorant strip is a multiple-choice question with four alternative responses. For example, one of the items reads: “This odor smells most like: a) chocolate; b) banana; c) onion; or d) fruit punch.” The test is forced-choice; i.e., the subject is required to mark one of the four alternatives even if no smell is perceived.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
65154 Olfactory test stick
A non-powered, scented device intended to be used to assess a patient’s olfactory function (normosmia, hyposmia, or anosmia). It typically consists of a scented stick(s) intended to be sniffed by the patient, followed by patient description of smell perception. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
NRK Kit, Test, Olfactory
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

155aa29a-90b1-4f6d-ac8d-008491d11b63
February 06, 2025
1
January 29, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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