BACTEC(R) 9000TB SYSTEM

K946268 · Becton Dickinson Diagnostic Instrument Systems · MDB · May 21, 1996 · Microbiology

Device Facts

• Record ID: K946268
• Device Name: BACTEC(R) 9000TB SYSTEM
• Applicant: Becton Dickinson Diagnostic Instrument Systems
• Product Code: MDB · Microbiology
• Decision Date: May 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Intended Use

Detection of mycobacteria in clinical respiratory specimens

Device Story

BACTEC 9000MB system detects mycobacterial growth in clinical respiratory specimens. System utilizes 7H9 Middlebrook broth base with nutrient additives and PANTA antimicrobial supplement. Principle of operation involves fluorescent detection of O2 consumption by mycobacteria via a sensor in a silicon rubber base. Instrument provides on-board incubation at 37°C ± 1.5°C with internal agitation every 10 minutes. Output is automated detection of mycobacterial growth, reducing time to detection compared to conventional media. Used in clinical laboratory settings by trained personnel to assist in diagnosis of mycobacterial infections.

Clinical Evidence

No clinical data provided. Comparison based on bench testing performance metrics including time to detection (TTD) and growth detection methodology versus BACTEC 460TB and conventional Lowenstein-Jensen media.

Technological Characteristics

Fluorescence sensor in silicon rubber base; 7H9 Middlebrook broth base; PANTA antimicrobial supplement; on-board incubation at 37°C ± 1.5°C; automated internal agitation every 10 minutes.

Indications for Use

Indicated for the detection of mycobacteria in clinical respiratory specimens.

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

• BACTEC 460TB

Reference Devices

• Lowenstein-Jensen medium (conventional media)

Submission Summary (Full Text)

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K 946268

MAY 21 1996

# SUMMARY OF SAFETY & EFFICACY

Table 1: BACTEC® 9000MB versus BACTEC® 460TB

| Intended Use | Detection of mycobacteria in clinical respiratory specimens | Detection of mycobacteria in clinical specimens |
| --- | --- | --- |
| Sample type | Primary sample type - respiratory | Primary sample type - respiratory; other body fluids (including blood) acceptable |
| Sample volume | 0.5 mL | 0.5 to 1.0 mL |
| Growth medium | 7H9 Middlebrook broth base with nutrient additives | 7H12 Middlebrook broth base with nutrient additives |
| Detector | Fluorescence sensor in silicon rubber base | 14C labeled fatty acid present in the media |
| Antimicrobial supplement | Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA) | Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA) |
| Growth detection | Fluorescent detection of O2 consumption by mycobacterial growth | Radiometric detection of CO2 liberated by mycobacterial growth |
| Time to detection (TTD) | Eleven to fifteen days | Seven to twelve days |
| Incubation temp. mixing | On-board incubation at 37°C ± 1.5°C; internal instrument agitation every 10 minutes. | External incubation at 37°C ± 1.0°C. No agitation in instrument. |

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# SUMMARY OF SAFETY & EFFICACY

Table 2: BACTEC® 9000MB versus CONVENTIONAL MEDIA

| Intended Use | Detection of mycobacteria in clinical respiratory specimens | Used for the cultivation of Mycobacterium tuberculosis and other mycobacterial species. |
| --- | --- | --- |
| Sample type | Primary sample type - respiratory | Primary sample type - respiratory; other body fluids (including blood) acceptable |
| Sample volume | 0.5 mL | 0.1 to 0.5 mL |
| Growth medium | 7H9 Middlebrook broth base with nutrient additives | Lowenstein-Jensen medium: Egg enriched agar base with nutrient additives |
| Detector | Fluorescence sensor in silicon rubber base | None |
| Antimicrobial supplement | Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA) | None |
| Growth detection | Fluorescent detection of O2 consumption by mycobacterial growth | Macroscopic observance of growth on media surface |
| Time to detection (TTD) | Eleven to fifteen days | Twenty-one to forty-nine days |
| Incubation temp. Mixing | On-board incubation at 37° ± 1.5°C; internal instrument agitation every 10 minutes. | 35°C to 38°C† Manual manipulation of media. |

*CONVENTIONAL MEDIA - Lowenstein-Jensen agar slants
†CDC recommendations

**TOTAL PAGE.013**