FDA UDI In Commercial Distribution 🇺🇸 United States

Sensonics Microencapsulated Smell Tests

DI: G051SITT0 · Model: SITT · Sensonics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sensonics Microencapsulated Smell Tests
Primary DI
G051SITT0
Version / Model
SITT
Company Name
Sensonics, Inc.
Labeler DUNS
107213563
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-29
Public Version
1
Public Version Date
2025-02-06
Public Version Status
New
Public Device Record Key
155aa29a-90b1-4f6d-ac8d-008491d11b63

Device Description

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.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NRK Kit, Test, Olfactory

GMDN Terms

Code Name
65154 Olfactory test stick

Identifiers

Type ID
Primary G051SITT0