MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)

• K Number: K031601
• Device Name: MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
• Manufacturer: DADE BEHRING, INC.
• Date Cleared: 2004-04-02 ( 317 days)
• Product Code: LON , JWY , LRG , LTT , LTW
• Regulation Number: 866.1645
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The MicroScan® rapID/S plus Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gramnegative bacilli. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway®SI or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Cephalothin, at concentrations of 0.5 to 32 µg/ml, to the test panel.

The gram-negative organisms which may be used for Cephalothin susceptibility testing in this panel are:

Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis

The MicroScan® Gram rapID/S plus Gram-Negative Panels with Cephalothin is not intended for use with:

Klebsiella oxytoca
Enterobacter spp.
Citrobacter freundii
Morganella morganii
Proteus vulgaris
Proteus penneri
Providencia spp
Serratia spp.
Yersinia enterolitica

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a specific antimicrobial susceptibility testing panel.

It states that the device is "substantially equivalent" to legally marketed predicate devices, and lists the indications for use and the specific organisms for which Cephalothin susceptibility can be tested. However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, or details on training sets.
3. Information on the number or qualifications of experts, or adjudication methods for ground truth.
4. Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
5. The type of ground truth used (e.g., pathology, outcomes data).

The letter generally references regulatory compliance and the intended use of the device but does not delve into the specifics of the underlying validation studies.

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”