Mueller Hinton Agar W/4%NACL and Oxacillin

• • Terminated Z-2608-2011 FDA Unclassified (pre-2012) ·initiated 20 Apr 2011

  Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.

510(k) Number

K863821 ↗

FDA Product Code

JTZ

Device Class

Class II

Regulation

21 CFR Part 866.1700

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Gibco Laboratories Life Technologies, Inc. →

• What is the primary purpose of the Mueller Hinton Agar with 4% NaCl and Oxacillin, and which bacteria does it specifically test for resistance?

  This product is designed for qualitative antimicrobial susceptibility testing to screen *Staphylococcus aureus* for resistance to penicillinase-resistant penicillins, including methicillin, nafcillin, and oxacillin. The inclusion of 4% sodium chloride (NaCl) and 6 µg/mL oxacillin in the Mueller Hinton Agar formulation helps identify such resistance in clinical microbiology settings.

• How is the Mueller Hinton Agar with 4% NaCl and Oxacillin supplied, and is it intended for single-use or repeated use?

  The medium is supplied as a powder for laboratory preparation, meaning it must be reconstituted before use. It is explicitly intended for single-use in microbiology settings, as outlined in the manufacturer’s instructions. Repeated use is not recommended due to potential contamination risks and loss of efficacy.

• What storage conditions are required to ensure the sterility and effectiveness of this product?

  Sterility and proper storage are critical for maintaining efficacy. While exact storage conditions are detailed in the manufacturer’s instructions (provided by Gibco Laboratories Life Technologies, Inc.), typical guidelines for culture media powders include storing in a cool, dry place (e.g., 2–8°C) away from direct light and moisture. Always follow the manufacturer’s guidelines to avoid degradation or contamination.

• How was this device classified by the FDA, and what regulatory pathway was followed for its clearance?

  The Mueller Hinton Agar with 4% NaCl and Oxacillin falls under FDA Class II regulatory classification (21 CFR 866.1700) and was cleared through a Traditional 510(k) pathway (K863821). The submission was reviewed by the Microbiology (MI) Advisory Committee in 1986, with a decision of Substantially Equivalent (SESE). This classification means it was deemed comparable to a legally marketed predicate device.