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Newborn Screening Specimen Collection Paper

Page Type
Product Code
Definition
Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
Physical State
Newborn screening specimen collection paper is an in vitro diagnostic device that consists of specifically designed filter paper with a uniform surface for the collection of blood spots. The collection paper is in the format of a printed card that incorporates a section for the collection of the patient¿s demographic information.
Technical Method
The blood is applied to the indicated spots on the paper. The specimen is allowed to dry and then sent to a laboratory for in vitro diagnostic analysis.
Target Area
An in vitro diagnostic device used as a medium to collect and transport whole blood specimen spots to a laboratory
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.

Newborn Screening Specimen Collection Paper

Page Type
Product Code
Definition
Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.
Physical State
Newborn screening specimen collection paper is an in vitro diagnostic device that consists of specifically designed filter paper with a uniform surface for the collection of blood spots. The collection paper is in the format of a printed card that incorporates a section for the collection of the patient¿s demographic information.
Technical Method
The blood is applied to the indicated spots on the paper. The specimen is allowed to dry and then sent to a laboratory for in vitro diagnostic analysis.
Target Area
An in vitro diagnostic device used as a medium to collect and transport whole blood specimen spots to a laboratory
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.