Access Ultrasensitive Insulin Assay

• • Ongoing Z-0981-2024 FDA Class II ·initiated 21 Nov 2023

  There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of IU/mL to the International System of Units (SI units) of pmol/L.

• • Terminated Z-1160-2008 FDA Unclassified (pre-2012) ·initiated 19 Sep 2007

  False negative results when used to test serum samples (as compared to plasma samples).

510(k) Number

K953084 ↗

FDA Product Code

CFP

Device Class

Class I

Regulation

21 CFR Part 862.1405

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K924289 Active Cleared 12 Feb 1993

• Access(R) Total Ige Assay

  Class II

  FDA 510(k) K930984 Active Cleared 9 Jun 1993

• Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

  Class II

  FDA 510(k) K963934 Active Cleared 16 Dec 1996

• Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200

  Class II

  FDA 510(k) K041658 Active Cleared 20 Dec 2004

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  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

See all devices from Bio-Rad Laboratories, Inc. →