Panels, Test, Susceptibility, Antimicrobial
FDA product code LTT · Class II (moderate risk) · 21 CFR 866.1640 · Microbiology
50510(k) clearances
0PMA approvals
13recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | Beckman Coulter, Inc. | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 08/15/2025SE |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 07/18/2025SE |
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )LTT · Traditional | Beckman Coulter, Inc. | 11/16/2020SE |
| K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)LTT · Special | Beckman Coulter, Inc. | 06/29/2020SE |
| K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/18/2020SE |
| K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/03/2020SE |
| K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam…LTT · Traditional | Beckman Coulter, Inc. | 02/12/2019SE |
| K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…LTT · Traditional | Beckman Coulter, Inc. | 12/15/2017SE |
| K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 12/07/2017SE |
| K172255 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 -…LTT · Traditional | Beckman Coulter, Inc. | 12/01/2017SE |
| K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/21/2017SE |
| K150039 | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)LTT · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/02/2015SE |
| K131275 | Microscan Dried Gram-Postive Mic/Combo PanelsLTT · Traditional | Siemens Helathcare Diagnostics, Inc. | 11/08/2013SE |
| K123933 | Microscan Dried Gram-Positive Mic/Combo Panels - CeftarolineLTT · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/14/2013SE |
| K111394 | Microscan MicrostepLTT · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/22/2011SE |
| K091949 | Microscan Microstrep Plus, Model B1027-201LTT · Special | Siemens Healthcare Diagnostics | 01/26/2010SE |
| K091264 | Microscan Dried Gram-Positive Mic/Combo Panels, Model B1017LTT · Traditional | Siemens Healthcare Diagnostics | 07/22/2009SE |
| K083262 | Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 Mcg/Ml)LTT · Traditional | Siemens Healthcare Diagnostics | 02/18/2009SE |
| K062773 | Microscan Microstrep Plus Panel, PenicillinLTT · Traditional | Dade Behring, Inc. | 10/13/2006SE |
| K062777 | Microscan Microstrep Plus Panel, ClindamycinLTT · Traditional | Dade Behring, Inc. | 10/10/2006SE |
| K033940 | Microscan Dried Gram-Negative Mic/Combo Panels-Amoxicillin/Clavulanate Potassium…LTT · Traditional | Dade Behring, Inc. | 02/25/2004SE |
| K030620 | Pasco Mic and Mic/Id PanelsLTT · Traditional | Pasco Laboratories, Inc. | 04/14/2003SE |
| K024357 | Sensititre 18-24 Hour Susceptibility PlatesLTT · Traditional | Trek Diagnostic Systems, Inc. | 03/17/2003SE |
| K024353 | Sensititre 18-24 Hours Susceptibility PlatesLTT · Traditional | Trek Diagnostic Systems, Inc. | 03/06/2003SE |
| K021184 | Microscan Microstrep Plus Panel New Antimicrobial-ClindamycinLTT · Traditional | Dade Microscan, Inc. | 06/20/2002SE |
| K021111 | Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeLTT · Traditional | Dade Microscan, Inc. | 06/06/2002SE |
| K021078 | Microscan Microstrep Plus Panel New Antimicrobial-ErythromycinLTT · Traditional | Dade Microscan, Inc. | 06/06/2002SE |
| K020939 | Microscan Microstrep Plus Panel-TetracyclineLTT · Traditional | Dade Microscan, Inc. | 05/17/2002SE |
| K020627 | Microscan Microstrep Plus Panel New Antimicrobial-GatifloxacinLTT · Traditional | Dade Microscan, Inc. | 05/06/2002SE |
| K020626 | Microscan Microstrep Plus Panel New Antimicrobial-PenicillinLTT · Traditional | Dade Microscan, Inc. | 04/26/2002SE |
| K020160 | Dried Gram-Positive Mic/Combo Panels with AmpicillinLTT · Traditional | Dade Behring, Inc. | 03/14/2002SE |
| K013368 | Haemophilus/Streptococcus Pneumoniae (HP) Mic PlateLTT · Traditional | Trek Diagnostic Systems, Inc. | 11/20/2001SE |
| K013195 | Haemophilus/Streptococcus Pneumoniae (Hp)Mic Susceptibility PlatesLTT · Traditional | Trek Diagnostic Systems, Inc. | 11/07/2001SE |
| K010418 | Dried Gram-Negative and Gram-Positive Mic/Combo PanelsLTT · Traditional | Dade Behring, Inc. | 08/22/2001SE |
| K010159 | Dried Gram-Negative and Gram-Positive Mic/Combo PanelsLTT · Traditional | Dade Microscan, Inc. | 07/27/2001SE |
| K011116 | Pasco Mic and Mic/Id Panels Inclusion of Esbl Confirmatory TestLTT · Traditional | Pasco Laboratories, Inc. | 04/24/2001SE |
| K010508 | Pasco Mic and Mic/Id PanelsLTT · Traditional | Pasco Laboratories, Inc. | 04/23/2001SE |
| K003619 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | Dade Microscan, Inc. | 01/09/2001SE |
| K001721 | Pasco Mic and Mic/Id PanelsLTT · Traditional | Pasco Laboratories, Inc. | 08/04/2000SE |
| K993102 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | Dade Microscan, Inc. | 12/02/1999SE |
| K983306 | Sensititre 18-24 Hour Susceptibility Plates with GrepafloxacinLTT · Traditional | Accumed Intl., Inc. | 12/18/1998SE |
| K983309 | Sensititre 19 - 24 Hour Susceptibility Plates with LevofloxacinLTT · Traditional | Accumed Intl., Inc. | 12/14/1998SE |
| K973317 | Pasco Mic and Mic/Id PanelsLTT · Traditional | Pasco Laboratories, Inc. | 11/14/1997SE |
| K972799 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | Dade Microscan, Inc. | 10/10/1997SE |
| K962150 | Dried Gram-Negative and Gram-Positive Mic/Combo PanelsLTT · Traditional | Dade Intl., Inc. | 08/16/1996SE |
| K960366 | Sensititre 18 Hour Susceptibility PlatesLTT · Traditional | Accumed Intl., Inc. | 04/09/1996SE |
| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | Baxter Diagnostics, Inc. | 04/14/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | Baxter Diagnostics, Inc. | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | Baxter Diagnostics, Inc. | 02/16/1995SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1794-2026 Class II | MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended…Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. | Beckman Coulter, Inc. | 09/08/2025Open, Classified |
| Z-1609-2026 Class II | MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are…Due to the likely presence of contamination in well(s). | Beckman Coulter, Inc. | 07/24/2025Open, Classified |
| Z-1772-2026 Class II | MicroScan Neg MIC 3J REF C54814Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics | Beckman Coulter, Inc. | 06/25/2025Open, Classified |
| Z-2599-2018 Class II | MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining…The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC… | Beckman Coulter Inc. | 05/04/2018Terminated |
| Z-0562-2016 Class II | MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos…Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless)… | Beckman Coulter Inc. | 12/01/2015Terminated |
| Z-0561-2016 Class II | MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos…Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless)… | Beckman Coulter Inc. | 12/01/2015Terminated |
| Z-0560-2016 Class II | MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels…Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless)… | Beckman Coulter Inc. | 12/01/2015Terminated |
| Z-0559-2016 Class II | MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels…Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless)… | Beckman Coulter Inc. | 12/01/2015Terminated |
| Z-0558-2016 Class II | MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels…Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless)… | Beckman Coulter Inc. | 12/01/2015Terminated |
| Z-0109-2016 Class II | MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus…Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error… | Beckman Coulter Inc. | 09/10/2015Terminated |
| Z-0108-2016 Class II | MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus…Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error… | Beckman Coulter Inc. | 09/10/2015Terminated |
| Z-1525-2013 Class II | Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #:…The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In… | Siemens Healthcare Diagnostics, Inc. | 05/02/2013Terminated |
| Z-1272-2013 Class II | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels.…Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads… | Siemens Healthcare Diagnostics, Inc. | 03/06/2013Terminated |