FDA.reportPublic FDA data

SpermAlign

Primary DI
15070002516207
Brand
SpermAlign
Company
CYTOSWIM LTD
Model
CYT 001
Device description
SpermAlign is a passive microfluidic device that separates sperm based on their motility. Separation is achieved through a defined microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilises a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and with media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in the respective procedure.
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQKLabware, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQKLabware, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232980000SpermAlign Sperm Separation DeviceCytoswim, Ltd.2024-03-14MQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25070002516204PackageGS1120In Commercial Distribution
15070002516207PrimaryGS10
05070002516200Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2507000251620425070002516204
1507000251620715070002516207
05070002516200050700025162005070002516200

GMDN Terms#

Term, Definition table
TermDefinition
Sperm filtration systemAn assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
224735036
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25070002516204SpermAlignCYT 0012025-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971855770377Minvitro Vitrification StrawGuangzhou Hehong Biotech Co., Ltd.MQK2026-03-10
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20888937025860PICSI®Coopersurgical, Inc.MQK2025-10-20
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00810195240019cryo-GO Vitrification Device - Yellow (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02
00810195240026cryo-GO Vitrification Device - Blue (Pack of 10)IRVINE SCIENTIFIC, LLCMQK2025-06-02