Sensonics' Microencapsulated Smell Tests

Basic Information

• Brand Name: Sensonics' Microencapsulated Smell Tests
• Primary DI: G051BSIT9
• Version / Model: BSIT
• 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: cbff3b76-7515-46cf-aa94-c84c77885c67

Device Description

The B-SIT is a brief 12-item self-administered microencapsulated odorant test for evaluating olfactory function. It is contained in a single booklet, unlike the 4-booklet UPSIT, and is applicable in any industrial, clinical, or survey setting where a rapid, yet reliable, assessment of olfactory function is required. As with the case of the UPSIT, the odorants are embedded in 10-50 µm urea-formaldehyde polymer micro-capsules fixed in a proprietary binder and positioned on scent strips at the bottom of the pages of the test booklet. The stimuli are released by scratching the 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) motor oil; b) garlic; c) rose; or d) lemon. The subject is required to mark one of the four alternatives even if no smell sensation is perceived (i.e., the test is forced-choice).

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRK	Kit, Test, Olfactory	Ear, Nose, Throat	874.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G051BSIT9	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]