Stat Profile Prime Abg

• FDA 510(k) K151982 decided 10 Sep 2015 Active
• FDA GUDID UDI-DI 00385480531047 listed 20 Sep 2016 Listed

• • Terminated Z-2732-2017 FDA Class II ·initiated 19 Jun 2017 ·on shared 510(k) K151982

  Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.

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

1. 10 Sep 2015 Cleared FDA 510(k) K151982
2. 20 Sep 2016 Listed FDA GUDID 00385480531047
3. 19 Jun 2017 Recall initiated FDA recalls Z-2732-2017

Trade name

Stat Profile

Generic name

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Model / Ref / Catalog

PRIME ABG, 53104

Primary DI / UDI-DI

00385480531047

510(k) Number

K151982 ↗

FDA product code

JIX

GMDN term

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Device class

Class II

Regulation number

862.1150

GUDID distribution status

In Commercial Distribution

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Other devices filed under FDA product code JIX (CALIBRATOR, MULTI-ANALYTE MIXTURE).

• Sentinel Plasmaproteins Cal 3X by Sentinel Ch. Srl
• Dimension Vista® LIPID CAL 10464345 KC220A by Siemens Healthcare Diagnostics Inc.
• DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS by Dade Intl., Inc.
• Sodium and Potassium Standard by Data Medical Associates, Inc.
• Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control by Dade Behring, Inc.
• ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II by ELITECHGROUP INC.
• Referril Calibrators by INSTRUMENTATION LABORATORY COMPANY
• Alinity 08P7001 by Abbott
• ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II by ELITECHGROUP INC.
• Pacific Hemostasis Reference Emulsion by Fisher Diagnostics

• StatSensor StatStrip Gen 2.0 Open recall

  Class II

  FDA 510(k) K232075 Active Cleared 23 Feb 2024 GUDID on market

• StatSensor StatStrip Geen 2.0 Open recall

  Class II

  FDA 510(k) K232075 Active Cleared 23 Feb 2024 GUDID on market

• Stat Profile Phox Ultra/Ccx

  Class I

  FDA 510(k) K110648 Active Cleared 29 Aug 2011 GUDID on market

• Stat Profile Phox Plus L

  Class II

  FDA 510(k) K023567 Active Cleared 20 Dec 2002 GUDID on market

See all devices from Nova Biomedical Corporation →