Container, Specimen Mailer And Storage, Sterile

Device Code: 4990

Product Code(s): KDT

Device Classification Information

• Device Type ID: 4990
• Device Name: Container, Specimen Mailer And Storage, Sterile
• Regulation Description: Specimen Transport And Storage Container.
• Regulation Medical Specialty: Pathology
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.3250 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KDT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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
• 13-9 CLSI AUTO2-A2
  Laboratory Automation: Bar Codes For Specimen Container Identification
• 13-10 CLSI AUTO1-A
  Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard

Total Product Life Cycle

• Device Type ID: 4990
• Device: Container, Specimen Mailer And Storage, Sterile
• Product Code: KDT
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Specimen Transport And Storage Container.
• CFR Regulation Number: 864.3250 [🔎]

Device Problems
Leak / Splash	24
Device Contamination With Chemical Or Other Material	16
Incorrect Or Inadequate Test Results	15
Short Fill	9
Device Markings / Labelling Problem	5
Material Deformation	5
Material Protrusion / Extrusion	3
Volume Accuracy Problem	3
Incorrect, Inadequate Or Imprecise Result Or Readings	3
Product Quality Problem	3
Delivered As Unsterile Product	3
Difficult To Insert	2
Break	1
Component Incompatible	1
Component Missing	1
Overfill	1
Total Device Problems	95

TPLC Last Update: 2019-04-02 20:58:32