FDA.report

SpermAlign

Primary DI
25070002516204
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 Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in the respective procedure.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
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
224735036
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
25070002516204PackageGS1120In Commercial Distribution
15070002516207PrimaryGS10
05070002516200Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
25070002516204PackageGS112015070002516207In Commercial Distribution
15070002516207PrimaryGS10
05070002516200Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MQKLabware, Assisted Reproduction2Obstetrics/Gynecology884.6160NEligible

Premarket Submissions

SubmissionSupplement
K232980000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K232980000SpermAlign Sperm Separation DeviceCytoswim, Ltd.2024-03-14MQK

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

No records found.

Other Devices Sharing Product Codes

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14719874742253LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
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24719874742250LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
24719874742281LensHooke Sperm Separation DeviceBONRAYBIO CO., LTD.MQK2025-02-16
00857515006658cryo-GO Vitrification DeviceFUJIFILM IRVINE SCIENTIFIC, INC.MQK2024-10-23
00857515006665cryo-GO Vitrification DeviceFUJIFILM IRVINE SCIENTIFIC, INC.MQK2024-10-23