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K Number
K971951
Device Name
PASCO MIC AND MIC/ID PANELS
Manufacturer
PASCO LABORATORIES, INC.
Date Cleared
1997-08-15

(79 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID 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 Levofloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA, which confirms that the Pasco MIC and MIC/ID Panels, with the inclusion of Levofloxacin, are substantially equivalent to previously marketed devices. It does not contain details about specific acceptance criteria or the study data itself.

The letter mentions:

  • Trade Name: Pasco MIC and MIC/ID Panels/Levofloxacin
  • Regulatory Class: II
  • Indication For Use: Quantitatively measuring (and qualitatively for Breakpoint/ID panel) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to antimicrobial agents and determining biochemical identification. Specifically, the addition of Levofloxacin at concentrations of 0.03 to 16 mcg/ml for most bacterial pathogens, with exceptions for Haemophilus and S. Pneumoniae.

However, it does not provide:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size, data provenance, number of experts for ground truth, or their qualifications.
  3. Adjudication method.
  4. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
  5. Information about a standalone (algorithm only) performance study.
  6. Type of ground truth used.
  7. Training set sample size.
  8. How ground truth for the training set was established.

To obtain this information, you would typically need to review the original 510(k) submission document or related study reports, which are not included in this letter.

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).