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Cefepime, 30 Mcg, Sensi-Disc

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K961188

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961188 Date5 Apr 1996ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1018-2024 FDA Class II initiated 8 Jan 2024

    There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JTN
Device Class
Class II
Regulation
21 CFR Part 866.1620
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cefepime, 30 Mcg, Sensi-Disc is a susceptibility test disc used in microbiology laboratories for antimicrobial testing. It is designed to determine the susceptibility of microorganisms to the antibiotic cefepime through disc diffusion methods.

This device is supplied as a single-use disc containing 30 mcg of cefepime and is intended for laboratory use only. It is not MRI compatible and should be stored according to manufacturer instructions. The device received FDA 510(k) clearance on April 5, 1996, with product code JTN and is classified as a Class II medical device.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cefepime 30 µg Sensi‑Disc used for?

    It is used in microbiology laboratories to assess the susceptibility of bacterial isolates to the antibiotic cefepime by the disc diffusion method, helping clinicians choose appropriate therapy.

  • How is the disc supplied and can it be reused?

    The product is supplied as an individual, single‑use disc containing 30 µg of cefepime. Because it is intended for a one‑time diffusion assay, it must be discarded after the test and cannot be reused.

  • Is the Cefepime Sensi‑Disc sterile and what are the storage requirements?

    Yes, each disc is sterile when packaged. The manufacturer advises storing the discs according to its instructions, typically in a dry, temperature‑controlled environment to maintain potency until use.

  • What regulatory classification does this device have?

    The disc is classified as a Class II medical device and received traditional FDA 510(k) clearance (product code JTN) on April 5 1996, indicating it is substantially equivalent to a legally marketed predicate.

  • Can the Cefepime Sensi‑Disc be used in MRI environments?

    No, the device is not MRI compatible. It should be kept away from magnetic resonance imaging equipment to avoid any risk of interference or damage.