MB/BACT MYCROBACTERIA DETECTION SYSTEM

K954468 · Organon Teknika Corp. · MDB · Jul 22, 1996 · Microbiology

Device Facts

• Record ID: K954468
• Device Name: MB/BACT MYCROBACTERIA DETECTION SYSTEM
• Applicant: Organon Teknika Corp.
• Product Code: MDB · Microbiology
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Intended Use

MB/BacT Process bottles are used with the MB/BacT Mycobacteria Detection System in qualitative procedures for recovery and detection of mycobacteria in clinical specimens other than blood.

Device Story

Automated system for mycobacteria growth and detection in clinical specimens (excluding blood). System utilizes broth culture bottles; colorimetric measurement of CO2 production detects microbial growth. Continuous monitoring replaces periodic manual checks; closed system design reduces technologist exposure to infectious agents. Instrument provides automated detection of positive cultures. Healthcare providers use results to identify mycobacterial presence in patient samples, facilitating clinical diagnosis and treatment decisions.

Clinical Evidence

Clinical comparison studies conducted at 4 sites evaluating MB/BacT against conventional solid media and BACTEC 460. Total of 395 isolates compared against solid media (MB/BacT detected 335, solid media 307) and 179 isolates compared against BACTEC 460 (MB/BacT detected 151, BACTEC 150). Bench testing included growth promotion studies using ATCC and CDC strains; detection thresholds ranged from 10^6 to 10^8 CFU/ml.

Technological Characteristics

Automated microbial growth monitor. Detection principle: colorimetric measurement of CO2 production in broth culture. System components: media bottle, antibiotic supplement, reconstitution fluid, and instrument. Closed-system design for continuous monitoring. Non-radiometric.

Indications for Use

Indicated for the recovery and detection of mycobacteria in clinical specimens other than blood.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• Lowenstein Jensen (LJ) slants (pre-amendment)
• Middlebrook 7H11 solid media (pre-amendment)
• Bactec 460 (pre-amendment)

Submission Summary (Full Text)

{0}

K954468
JUL 22 1996

# 510(k) Summary

## BacT/Alert MB/BacT Mycobacteria Detection System

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.

### (A)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:

Submitter's Name: Organon Teknika Corporation
Submitter's Address: 100 Akzo Avenue, Durham, NC, 27712
Submitter's Telephone: [phone]
Submitter's Contact: Ann M. Quinn
Date 510(k) Summary Prepared: July 11, 1996

### (a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known.

Trade or Proprietary Name: MB/BacT Mycobacteria Detection System
Common or Usual Name: Microbial Growth Monitor
Classification Name: Microbial Growth Monitor

### (a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence.

Device Equivalent to: Manual Methods including Lowenstein Jensen (LJ) slants, Middlebrook 7H11 solid media and Bactec 460, all of which are pre amendment devices.

### (a)(4) A description of the device

Device description: Automated system for growth and detection of mycobacteria organisms in clinical specimens other than blood.

### (a)(5) A statement of the intended use of the device

Device Intended Use: MB/BacT Process bottles are used with the MB/BacT Mycobacteria Detection System in qualitative procedures for recovery and detection of mycobacteria in clinical specimens other than blood.

mbbact4(6/28/96)

{1}

(a)(6) **A summary of the technological characteristics of the new device in comparison to those of the predicate device.**

MB/BacT Mycobacteria Detection System detects the growth of mycobacteria in a broth culture bottle by colorimetric measurement of CO₂ production. Bactec 460 detects the growth of mycobacteria in a broth culture bottle by radiometric measurement of CO₂ production. Manual solid media methods such as Lowenstein Jensen slants or Middlebrook 7H11 plates, growth is detected by visual examination. MB/BacT cultures are continuously monitored while the other methods are monitored periodically. MB/BacT is a closed monitoring system once the specimen is inoculated into the bottle. This limits the technologist's exposure to potentially infectious organisms. This safety feature is not present in the other systems.

(b)(1) **A brief discussion of the nonclinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.**

Growth promotion studies were performed on the MB/BacT Process System which consists of the media bottle, antibiotic supplement, and reconstitution fluid along with the MB/BacT instrument. These data were generated to demonstrate that the media was capable of growing several strains of mycobacteria in vitro. ATCC strains were used and clinical strains not commonly encountered were obtained from CDC for testing. These data demonstrate the MB/BacT Process System is capable of supporting growth of a variety of mycobacteria organisms. Colony counts were performed on select strains to determination the level of growth to trigger a positive reading by the instrument. These counts ranged from 10⁶ to 10⁸ CFU/ml. Data was generated on select strains of mycobacteria at different concentrations comparing MB/BacT to Bactec 460. Times to detection ranged from 7.9 to 17.1 days for MB/BacT and from 5 to 14 days for Bactec 460 (when a G.I. of 50 was considered positive).

(b)(2) **A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalency.**

Comparison Studies were conducted at 4 clinical sites to evaluate the performance of the MB/BacT Mycobacteria Detection System compared to conventional solid media for growth and detection of mycobacteria. One of the sites also used the BACTEC 460 in addition to conventional solid media. The comparative methods used at the sites were as follows:

| Site | Comparative Method |
| --- | --- |
| Site A | Lowenstein-Jensen Slants
Middlebrook 7H11 bi-plates containing selective and non-selective media |
| Site B | Lowenstein-Jensen Slants
Middlebrook 7H11 selective agar slants |
| Site C | Lowenstein-Jensen Slants
Middlebrook 7H11 bi-plates containing selective and non-selective media |

mbbact4(6/28/96)

{2}

Site D Lowenstein-Jensen Slants
Middlebrook 7H11 bi-plates containing
selective and non-selective media
BACTEC 460 TB

Site E Lowenstein-Jensen Slants
BACTEC 460TB

A summary of the organisms recovered and comparison to the predicate devices is provided in the following tables.

## Recovery of Mycobacteria species - MB/BacT vs BACTEC

| Mycobacteria species only | Total recovered | MB/BacT pos | MB/BacT pos only | Bactec pos | Bactec pos only | Solid pos | Solid pos |
| --- | --- | --- | --- | --- | --- | --- | --- |
| M. avium | 67 | 52 | 4 | 61 | 10 | 43 | 0 |
| M. chelonae | 6 | 4 | 0 | 6 | 2 | 2 | 0 |
| M. gordonae | 21 | 17 | 14 | 7 | 2 | 3 | 0 |
| M. intracellulare | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| M. kansasii | 2 | 2 | 0 | 2 | 0 | 2 | 0 |
| M. simiae | 1 | 1 | 0 | 1 | 0 | 1 | 0 |
| M. tuberculosis | 79 | 74 | 4 | 71 | 2 | 65 | 0 |
| M. xenopi | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Atypical mycobacteria | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Total isolates | 179 | 151 | 22 | 150 | 18 | 117 | 0 |

## Recovery of Mycobacteria species - MB/BacT vs Solid Media

| Mycobacteria species | Total recovered | MB/BacT pos | MB/BacT pos only | Solid pos | Solid pos only |
| --- | --- | --- | --- | --- | --- |
| M. avium | 132 | 111 | 38 | 94 | 21 |
| M. chelonae | 6 | 5 | 3 | 3 | 1 |
| M. fortuitum | 7 | 6 | 3 | 4 | 1 |
| M. gordonae | 31 | 30 | 24 | 7 | 1 |
| M. kansasii | 12 | 9 | 2 | 10 | 3 |
| M. terrae | 1 | 0 | 0 | 1 | 1 |
| M. tuberculosis | 205 | 173 | 18 | 187 | 32 |
| M. xenopi | 1 | 1 | 0 | 1 | 0 |
| Total isolates | 395 | 335 | 88 | 307 | 60 |

mbbact4(6/28/96)

{3}

(b)(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

The performance characteristics of the new device are comparable to those of the predicate devices and typical of methods used for detection of mycobacteria. The data presented in the premarket notification demonstrate that the new device performs substantially equivalent to the predicate devices.

mbbact4(6/28/96)