# K031727: Pasco Mic and Mic/ID Panels, Gemifloxacin

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Jul 30, 2003 after 57 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: 1 generation back to K946126 (1995). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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) Summary page 1.
- 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.

## Most influential descendants
- K033119: Pasco Mic and Mic/ID Panels (2003), 0 descendants of its own

## Indications for use
Pasco MIC and MIC/ID 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 510(k) notification is for the addition of the antimicrobial Gemifloxacin at concentrations of 0.015 .. 4 mcg/ml to Pasco Panels. Gemifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert-forthis antimicrobic. Active In Vitro and in Clinical Infectious Against: Aerobic Gram-negative microorganisms Klebsiella pneumoniae Active In Vitro but their clinical significance is unknown Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptiblestrains only) Aerobic Gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris

Source page: https://510kreport.com/device/K031727
Methodology: https://510kreport.com/methodology