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Capillary Blood Collection Device For Alternative Site Collection

Page Type
Product Code
Definition
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
Physical State
Sterile blood collection device which may or may not have micro-needles or other skin puncture mechanism integrated with the device. The device may include an anticoagulant or preservative.
Technical Method
The blood is drawn into the collection device by puncture of capillaries located near the surface of the skin using micro-needles or similar small sharp objects.
Target Area
Capillary whole blood for in vitro diagnostic testing
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1675
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1675 Blood specimen collection device

§ 862.1675 Blood specimen collection device.

(a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

(b) Classification. Class II.

Capillary Blood Collection Device For Alternative Site Collection

Page Type
Product Code
Definition
A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
Physical State
Sterile blood collection device which may or may not have micro-needles or other skin puncture mechanism integrated with the device. The device may include an anticoagulant or preservative.
Technical Method
The blood is drawn into the collection device by puncture of capillaries located near the surface of the skin using micro-needles or similar small sharp objects.
Target Area
Capillary whole blood for in vitro diagnostic testing
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1675
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1675 Blood specimen collection device

§ 862.1675 Blood specimen collection device.

(a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

(b) Classification. Class II.