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510(k) Data Aggregation
K Number
K222084Device Name
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
Manufacturer
Date Cleared
2022-11-02
(110 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Asahi Polyslider Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Capiject® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.
Device Description
The Single Use Blood Lancets are hand-held, sterile, needle or blade-like devices with a pull-off or twistoff cap and integral sharps injury prevention feature for controlled skin puncture to obtain a capillary blood specimen; typically at the fingertip or heel of the patient. The housing of the devices are made of plastic and have a spring-loaded mechanism which enables the tip of the needle or blade to puncture the fingertip or heel to a predetermined depth, whereby blood is subsequently squeezed out of the puncture site. These devices are made available in various needle and blade sizes which are distinguished by their different colors. Until activation, the lancet is contained within its housing (holder). Immediately after use, the needle or blade is automatically retracted back into its holder until the device is disposed of in an appropriate manner.
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K Number
K221546Device Name
OneTouch Delica Plus Lancing System
Manufacturer
Date Cleared
2022-08-23
(88 days)
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Asahi Polyslider Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OneTouch® Delica® Plus lancets are sterile, single use devices that have been designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples from the fingertips. The OneTouch Delica Plus lancets are compatible with the single patient use OneTouch® Delica® Plus lancing device.
Device Description
The OneTouch® Delica® Plus Lancing System consists of a non-sterile, reusable base blood lancing device that is intended for use on a single patient and is used in conjunction with a sterile, single-use lancet. The lancing device has 13 depth settings. The lancets are made available in size 30G and are packaged in boxes of 30 and 100 count.
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