← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K121863

# VITEK 2 AST-ST CEFOTAXIME (K121863)

_bioMerieux, Inc. · LON · Aug 16, 2012 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K121863

## Device Facts

- **Applicant:** bioMerieux, Inc.
- **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md)
- **Decision Date:** Aug 16, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

VITEK® 2 AST - ST Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST - ST Cefotaxime is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Cefotaxime has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Streptococcus pneumoniae. Streptococcus pyogenes (Group A betahemolytic streptococci), Streptococcus spp. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli. Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

## Device Story

VITEK® 2 AST-ST Cefotaxime is an automated, miniaturized, and abbreviated version of the doubling dilution technique for determining minimum inhibitory concentration (MIC). The device uses 64-well cards containing premeasured antibiotic concentrations (0.25, 0.5, 1, and 2 µg/ml) and culture media. Isolated bacterial colonies are diluted in saline, then used to rehydrate the card. The VITEK® 2 system automatically fills, seals, and incubates the card; the VITEK® 2 Compact system requires manual filling/sealing. An optical scanner monitors well growth via light transmittance over 4-16 hours. The system generates an MIC value and interpretive category (Susceptible, Intermediate, Resistant) based on growth thresholds. Used in clinical laboratories by technicians to aid in determining in vitro susceptibility to antimicrobial agents, helping clinicians select appropriate antibiotic therapy for patients with Streptococcus infections.

## Clinical Evidence

Performance established via clinical study of 1416 viable clinical isolates and a challenge set of 207 isolates. Combined clinical and challenge data showed 99.0% Essential Agreement (EA) and 96.5% Category Agreement (CA) for all Streptococcus species. No very major errors were observed. Minor categorical errors were 3.3% for combined species. Bench testing included reproducibility studies (>95% agreement) and quality control testing using both automatic and manual dilution methods, confirming performance comparable to CLSI broth microdilution reference methods.

## Technological Characteristics

Miniaturized 64-well plastic test card; contains premeasured antibiotic and culture media. Sensing principle: optical scanner measuring light transmittance (visible light) to detect bacterial growth. Energy source: electrical (VITEK® 2/Compact systems). Connectivity: networked/standalone system integration. Software: automated growth-based detection algorithm. Sterilization: not specified.

## Regulatory 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.

## Special Controls

*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.”

## Submission Summary (Full Text)

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Decision Summary, k121863

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K121863](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K121863)

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