Aia-Pack Tgab Assay

• • Terminated Z-2827-2018 FDA Class III ·initiated 5 Jun 2018 ·on shared 510(k) K981522

  Distribution of unapproved product labeling

• • Terminated Z-2169-2017 FDA Class III ·initiated 8 Feb 2017

  The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

• • Terminated Z-1187-2021 FDA Class II ·initiated 23 Feb 2012

  Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K981522 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

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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