Statsensor 1.0

• FDA 510(k) K070068 decided 7 May 2007 Active
• FDA GUDID UDI-DI 00385480439213 listed 16 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. 16 Sep 2016 Listed FDA GUDID 00385480439213

Trade name

Statsensor

Generic name

Creatinine IVD, control

Model / Ref / Catalog

1.0, 43921

Primary DI / UDI-DI

00385480439213

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

Other devices filed under FDA product code JJX (Single (specified) analyte controls (assayed and unassayed)).

• SUGAR-CHEX II by Streck Laboratories, Inc.
• CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1, 2, 3 by Cala Diagnostics
• IRMA TRUPOINT CREATININE CONTROL KIT by International Technidyne Corp.
• CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E by Cliniqa Corporation
• Atellica IM Androstenedione MCM 11200557 by Siemens Healthcare Diagnostics Inc.
• ABT GLUCOSE CONTROL SOLUTION LEVEL 1, 2, 3 MODEL, 2120083, 2120086, 2120087 by American Biological Technologies, Inc.
• ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P by Roche Diagnostic Systems, Inc.
• Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity by Aalto Scientific, Ltd.
• ARCHITECT 1L71-01 01L7101 by Abbott
• ACA LIPASE VERIFIERS by E.I. Dupont DE Nemours & Co., Inc.

• 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 →