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U.S. Department of Health and Human Services

Product Classification

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Device automated platform consisting of software and instrumentation for pooling and/or lysing donor blood, serum, or plasma
Regulation Description Pipetting and diluting system for clinical use.
Definition Instrument used to create pools of whole blood, whole blood lysates, serum, and /or plasma, for use in blood donor screening tests. May include sample preparation steps such as lysing of whole blood samples.
Physical State Computer controlled system composed of a pipetting instrument and software, with a work surface for pipettors, reagents, and various tubes (sample, intermediate, pooling) to facilitate the pooling workflows. May include lysis and other sample preparation devices. May also include bar code reader or other method to control sample tracking and workflow and LIS connectivity.
Technical Method Automated lysis and/or pooling platform consisting of pipetting and sample preparation instrument and software
Target Area Blood, serum, or plasma
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQBZ
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(K) Exempt
Regulation Number 862.2750
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible