Modification of Abl Mic-10 Precept Sys

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

510(k) Number

K843612 ↗

FDA Product Code

LTD

Device Class

Class III

Advisory Committee

Unknown

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 primary use of the ABL MIC-10 Precept System in a clinical lab setting?

  The ABL MIC-10 Precept System is specifically designed for determining the minimum inhibitory concentrations (MICs) of antimicrobial agents against bacterial isolates. It uses a microdilution tray method to measure how effective different antibiotics are in inhibiting bacterial growth, helping clinicians select the most appropriate treatment options for infections.

• Is the ABL MIC-10 Precept System intended for single-use or repeated use, and how does this affect its handling?

  The ABL MIC-10 Precept System is supplied as a single-use, non-sterile device. This means each disposable plastic tray is meant for one-time use only, requiring reconstitution with bacterial suspensions before testing. After use, the tray should be discarded to avoid cross-contamination and ensure accurate results.

• How is the device classified under FDA regulations, and what does this mean for its use?

  The ABL MIC-10 Precept System is classified as a Class III device under FDA regulations, which typically means it carries higher risk and requires strict compliance with manufacturing and performance standards. It holds an FDA 510(k) clearance (K843612) under the Traditional 510(k) Review pathway, demonstrating that it is considered substantially equivalent to a legally marketed device already on the market.

• What kind of preparation is required before using the ABL MIC-10 Precept System, and why is this important?

  The disposable trays in the ABL MIC-10 Precept System come pre-filled with dehydrated antimicrobial agents, but they must be reconstituted with bacterial suspensions before use. This step is critical because it ensures accurate MIC testing by allowing the antimicrobial agents to interact properly with the bacterial samples, providing reliable susceptibility results for clinical decision-making.

• What regulatory pathway was followed for the FDA clearance of this device, and what does this imply about its development?

  The ABL MIC-10 Precept System was cleared through the Traditional 510(k) Review pathway, meaning the manufacturer demonstrated that it is substantially equivalent to a legally marketed device already on the market. This pathway involves a detailed submission to the FDA, including clinical and performance data, to ensure the device meets safety and effectiveness standards before clearance.