Precept Netilmicin 32-13 Susceptibility Test Cards

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Precept Netilmicin 32-13

510(k) Number

K853687 ↗

FDA Product Code

LTW

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Rim Spot Indole

  Class I

  FDA 510(k) K842097 Active Cleared 7 Jun 1984

• Rim-Haemophilus 2

  Class I

  FDA 510(k) K832239 Active Cleared 12 Aug 1983

• Precept Ticarcillin/Clavulanic Acid

  Class II

  FDA 510(k) K864069 Active Cleared 13 Nov 1986

• Rim - Nitrate Test

  Class I

  FDA 510(k) K841270 Active Cleared 20 Apr 1984

• Rim-Bile Esculin Test

  Class I

  FDA 510(k) K841262 Active Cleared 20 Apr 1984

• Austin Enteric System

  Class I

  FDA 510(k) K860194 Active Cleared 20 Feb 1986

See all devices from Austin Biological Laboratories →

• What is the Precept Netilmicin 32-13 used for in a clinical setting?

  The Precept Netilmicin 32-13 is a single-use antimicrobial susceptibility test card specifically designed for in vitro microbiological testing. It helps determine whether bacteria are susceptible or resistant to netilmicin, an aminoglycoside antibiotic, allowing laboratories to guide appropriate antibiotic treatment decisions.

• Are these test cards intended for reuse, or are they single-use only?

  These cards are explicitly labeled as single-use diagnostic tools. They are meant for one-time use in microbiology laboratories to ensure accurate and reliable antimicrobial susceptibility testing without carryover contamination or degradation.

• How is the Precept Netilmicin 32-13 supplied, and what should I consider for storage?

  The cards are supplied as part of a single-use diagnostic kit for in vitro laboratory use. While specific storage instructions are not detailed in the data, standard practice for antimicrobial susceptibility test cards typically requires storage in a clean, dry environment protected from extreme temperatures and light to preserve sterility and integrity until use.

• What regulatory pathway was followed for FDA clearance of this device?

  The Precept Netilmicin 32-13 received FDA clearance through a Traditional 510(k) review process under the Microbiology advisory committee (MI). The device was classified as Substantially Equivalent (SESE) to a predicate and falls under Class II regulatory classification (product code LTW), regulated under 21 CFR 866.1640. No third-party review or combination product designation applies.