# K033119: Pasco Mic and Mic/ID Panels - Pathway: 510(k) (Traditional) - Applicant: Pasco Laboratories, Inc. - Decided: Nov 18, 2003 after 49 days - Product code: JWY (Manual Antimicrobial Susceptibility Test Systems) - Device class: 2 - Regulation: 21 CFR 866.1640 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K946126 (1995). 35 ancestors in all. No later device cites it as a predicate yet. 0 of 36 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K032259: Pasco Mic and Mic/ID Panels, Bd Diagnostic Systems (2003) Summary page 1. - K032518: Pasco Mic and Mic/ID Panels, Gemifloxacin (Strep), Bd Diagnostic Systems (2003) - K031727: Pasco Mic and Mic/ID Panels, Gemifloxacin, Pasco Laboratories, Inc. (2003) - K031205: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2003) - K031103: Pasco Mic and Mic/ID Panels (Ertapenem), Pasco Laboratories, Inc. (2003) - K030933: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2003) Summary page 1. - K030620: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2003) Summary page 1. - K011116: Pasco Mic and Mic/ID Panels Inclusion of Esbl Confirmatory Test, Pasco Laboratories, Inc. (2001) - K010508: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2001) Summary page 1. - K020331: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2002) Summary page 1. - K001953: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2000) - K001887: Modification to Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2000) - K001721: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2000) - K001612: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2000) - K001516: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (2000) - K992853: Pasco Mic and Mic/ID Panels, Cefdinir, Pasco Laboratories, Inc. (1999) Summary page 1. - K992726: Pasco Mic and Mic/ID Panels, Quinupristin/Dalfopristin for Nonfastidious Organisms, Pasco Laboratories, Inc. (1999) Summary page 1. - K992717: Pasco Mic and Mic/ID Panels,Quinupristin/Dalfopristin, Pasco Laboratories, Inc. (1999) Summary page 1. - K992646: Pasco Mic and Mic/ID Panels, Penicillin, Pasco Laboratories, Inc. (1999) Summary page 1. - K992647: Pasco Mic and Mic/ID Panels, Erythromycin, Pasco Laboratories, Inc. (1999) Summary page 1. - K992593: Pasco Mic and Mic/ID Panels, Chloramphenicol, Pasco Laboratories, Inc. (1999) Summary page 1. - K992562: Pasco Mic and Mic/ID Panels, Ceftriaxone, Pasco Laboratories, Inc. (1999) Summary page 1. - K992568: Pasco Mic and Mic/ID Panels, Cefotaxime, Pasco Laboratories, Inc. (1999) Summary page 1. - K992507: Pasco Mic and Mic/ID Panels, Trovafloxacin, Pasco Laboratories, Inc. (1999) Summary page 1. - K992546: Pasco Mic and Mic/ID Panels, Meropenem, Pasco Laboratories, Inc. (1999) Summary page 1. - K992420: Modification of Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (1999) Summary page 1. - K992296: Pasco Mic and Mic/ID Panels, Vancomycin, Pasco Laboratories, Inc. (1999) Summary page 1. - K992297: Pasco Mic and Mic/ID Panels, Levofloxacin, Pasco Laboratories, Inc. (1999) Summary page 1. - K992143: Modification to Pasco Mic and Mic/ID Panels (Clindamycin), Pasco Laboratories, Inc. (1999) Summary page 1. - K992108: Pasco Mic and Mic/ID Panels (Cefepime), Pasco Laboratories, Inc. (1999) Summary page 1. - K992076: Pasco Mic and Mic/ID Panels (Cefuroxime), Pasco Laboratories, Inc. (1999) Summary page 1. - K992059: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (1999) Summary page 1. - K992077: Pasco Mic and Mic/ID Panels (Ofloxacin), Pasco Laboratories, Inc. (1999) Summary page 1. - K991925: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (1999) Summary page 1. - K946126: Pasco Mic and Mic/ID Panels, Pasco Laboratories, Inc. (1995) Summary page 1. ## Indications for use Pasco MIC and MICAD panels are used for quantitatively measuring (with the exception of the BreakpoindID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 5,10(k) notification is for the addition of the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels. Daptomycin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic. Active In Vitro and in Clinical Infectious Apainst: Aerobic Gram-positive microorganisms Enterococcusfaecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains) Active In Vitro but their clinical simificance is unknown Aerobic Gram-positive microorganisms Enterococcusfaecalis (vancomycin-resistant strains) Enterococcus fuecium (including vancomycin-resistant strains) Stuphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus huemolyticus Source page: https://510kreport.com/device/K033119 Methodology: https://510kreport.com/methodology