StatSensor Creatinine

• FDA 510(k) K070068 decided 7 May 2007 Active
• FDA GUDID UDI-DI 00385480440370 listed 20 Sep 2016 Listed

• • Terminated Z-0650-2014 FDA Class II ·initiated 10 Oct 2013 ·on shared 510(k) K070068

  Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage

• • Terminated Z-1472-2008 FDA Unclassified (pre-2012) ·initiated 21 Feb 2008 ·on shared 510(k) K070068

  Lithium batteries may fail if the glucose or creatinine meters have been dropped.

• 3 recalls, same reason

  • Terminated Z-0724-2008 FDA Unclassified (pre-2012) ·initiated 2 Nov 2007 ·on shared 510(k) K070068
  • Terminated Z-0726-2008 FDA Unclassified (pre-2012) ·initiated 2 Nov 2007 ·on shared 510(k) K070068
  • Terminated Z-0725-2008 FDA Unclassified (pre-2012) ·initiated 2 Nov 2007 ·on shared 510(k) K070068

  Incorrect Results - Creatinine results were lower than the laboratory reference method.

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

1. 7 May 2007 Cleared FDA 510(k) K070068
2. 2 Nov 2007 Recall initiated FDA recalls Z-0724-2008
3. 2 Nov 2007 Recall initiated FDA recalls Z-0726-2008
4. 2 Nov 2007 Recall initiated FDA recalls Z-0725-2008
5. 21 Feb 2008 Recall initiated FDA recalls Z-1472-2008
6. 10 Oct 2013 Recall initiated FDA recalls Z-0650-2014
7. 20 Sep 2016 Listed FDA GUDID 00385480440370

Trade name

StatSensor

Generic name

Creatinine IVD, control

Model / Ref / Catalog

Creatinine, 44037

Primary DI / UDI-DI

00385480440370

510(k) Number

K070068 ↗

FDA product code

JJX

GMDN term

Creatinine IVD, control

Device class

Class I

Regulation number

862.1660

GUDID distribution status

In Commercial Distribution

Category: Creatinine IVD, control

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• 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 →