G7 Automated Hplc Analyzer, Beta-Thalassemia Mode

• • Terminated Z-3030-2011 FDA Unclassified (pre-2012) ·initiated 25 May 2011

  The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.

• • Terminated Z-1075-2013 FDA Class III ·initiated 18 Aug 2010

  The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.

510(k) Number

K020489 ↗

FDA Product Code

JPD

Device Class

Class II

Regulation

21 CFR Part 864.7400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Aia-Pack Hgh

  Class I

  FDA 510(k) K905757 Active Cleared 25 Jan 1991

• Aia-Pack Bmg

  Class II

  FDA 510(k) K900440 Active Cleared 26 Feb 1990

• St Aia-Pack Ca 125 Enzyme Immunoassay

  Class II

  FDA 510(k) K023891 Active Cleared 6 Dec 2002

• Aia-Pack Pap Calibration Verification Test Set

  Class I

  FDA 510(k) K924854 Active Cleared 16 Nov 1992

• Aia-Pack Ctni 2ND-Gen Assay

  Class II

  FDA 510(k) K012820 Active Cleared 14 Dec 2001

• Aia-Pack B12 Assay

  Class II

  FDA 510(k) K964348 Active Cleared 13 Jan 1997

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