Sta Compact Automated Multi-parametric Analyzer

• • Terminated Z-0039-2008 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007

  Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

• • Terminated Z-0812-2007 FDA Unclassified (pre-2012) ·initiated 18 Jan 2007

  Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

• • Terminated Z-0899-03 FDA Unclassified (pre-2012) ·initiated 5 Mar 2003

  With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

510(k) Number

K961579 ↗

FDA Product Code

GKP

Device Class

Class II

Regulation

21 CFR Part 864.5400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the STA Compact Automated Multi-parametric Analyzer used for?

  The STA Compact Automated Multi-parametric Analyzer is designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy, as it is a fully automated laboratory analyzer intended for use in laboratory settings to support coagulation testing and anticoagulant therapy monitoring.

• How is the STA Compact Automated Multi-parametric Analyzer supplied and what is its regulatory status?

  The device is supplied by American Bioproducts Co. and received FDA 510(k) clearance (K961579) on July 10, 1996, following a traditional review process, and is classified as an Instrument, Coagulation, Automated under product code GKP and falls under Class II with special controls.

• What type of review process did the STA Compact Automated Multi-parametric Analyzer undergo for FDA clearance?

  The STA Compact Automated Multi-parametric Analyzer received FDA 510(k) clearance through a traditional review process, as indicated in the decision description and clearance type fields, which state 'Substantially Equivalent' and 'Traditional' respectively.