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Device
tubes, vials, systems, serum separators, blood collection
Regulation Description
Blood specimen collection device.
Regulation Medical Specialty
Clinical Chemistry
Review Panel
Clinical Chemistry
Product Code
JKA
Premarket Review
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type
510(k)
Regulation Number
862.1675
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Ineligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Recognized Consensus Standards
7-213 CLSI GP44-A4 (Formerly H18-A4)
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
7-221 CLSI GP39-A6 (Formerly H01-A6)
Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
7-225 CLSI GP34-A (Replaces GP34-P)
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
7-244 CLSI NBS01-A6 (Replaces LA04-A5)
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
7-277 CLSI GP41 7th Edition
Collection of Diagnostic Venous Blood Specimens
7-301 CLSI GP42 7th Edition
Collection of Capillary Blood Specimens
7-316 CLSI NBS01 7th Edition
Dried Blood Spot Specimen Collection for Newborn Screening
Third Party Review
Not Third Party Eligible
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