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510(k) Data Aggregation
(72 days)
CHROMID CARBA agar (CARB)
CHROMID® CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID® CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting.
Rectal swabs are inoculated directly onto CHROMID® CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey.
Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID® CARBA agar with colonies that appear pink to burgundy or blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing.
A lack of growth or the absence of pink to burgundy or blue-grey colonies does not preclude the carriage of carbapenemase producing organisms.
CHROMID® CARBA agar consists of a nutritive base combining different peptones, 3 chromogenic substrates and antibiotics. These components enable the screening and presumptive identification of E. coli: spontaneous coloration (pink to burgundy) of strains producing ß-glucuronidase (ß-GUR) and/or ß-galactosidase (ß-GAL) and K. pneumoniae: spontaneous blue-green to bluish-grey coloration of strains producing ß-glucosidase (ß-GLU) from rectal swabs.
The document describes the regulatory approval of CHROMID® CARBA agar, a chromogenic medium for detecting carbapenemase-producing Escherichia coli and Klebsiella pneumoniae. While it specifies the device's performance, it doesn't present "acceptance criteria" in a typical table format with specific target values like "sensitivity > X%" and "specificity > Y%." Instead, it details the results of analytical and clinical studies to demonstrate the device's acceptable performance and substantial equivalence to a predicate device.
Here's an attempt to structure the information based on your request, inferring acceptance criteria from the presented results:
1. Table of Acceptance Criteria (Inferred from Study Results) and Reported Device Performance
Since explicit numerical acceptance criteria were not directly stated, they are inferred based on the observed "acceptable results" and high agreement percentages across various studies.
| Acceptance Criteria Category | Inferred Acceptance Threshold (Goal) | Reported Device Performance (CHROMID® CARBA agar) |
|---|---|---|
| Analytical Performance | ||
| Limit of Detection (LOD) | Low CFU/mL detected for target strains. | 1.5x10³ CFU/mL for K. pneumoniae ATCC® 1705™ and E. coli ATCC® 2340™. |
| Cross Reactivity (Specificity) | Minimal cross-reactivity with non-target organisms; Characteristic coloration for CPE. | 16 CPE strains (various species and carbapenemases) grew with characteristic pink/blue-green/blue-grey colonies. Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Pseudomonas putida, and Acinetobacter baumanii grew but without characteristic coloration (colorless), indicating acceptable specificity. |
| Challenge Testing (Reactivity) | High recovery rate of target strains with characteristic colors. | K. pneumoniae: All 41 strains recovered with characteristic blue-green color. |
| E. coli: 9/11 strains grew with characteristic burgundy color; 2 E. coli failed (one had intermediate MICs, the other susceptible to carbapenems). | ||
| Mixed Infection | Target organisms detectable in presence of other flora up to certain concentrations. | When competitive species were |
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