(299 days)
BACTEC® 460TB System, BBL® SEPTI-CHEK® AFB Mycobacteria Culture System
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No
The device description and performance studies focus on a chemical reaction (fluorescence based on oxygen consumption) and comparison to control tubes for interpretation, not algorithmic analysis of data. There is no mention of AI, ML, or image processing.
No
The device is intended for the detection and recovery of mycobacteria, which is a diagnostic purpose, not a therapeutic one. It identifies the presence of microorganisms, but does not treat or alleviate any condition.
Yes
The device detects and recovers mycobacteria from clinical specimens, which are used to determine the presence of an infection, thus making it a diagnostic device.
No
The device description clearly outlines physical components (tubes, broth, fluorescent compound) and a manual reading process, indicating it is a hardware-based diagnostic system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "detection and recovery of mycobacteria from decontaminated clinical specimens (except urine) and sterile body fluids (except blood)." This is a diagnostic purpose performed on samples taken from the human body.
- Device Description: The device description details a method for detecting the presence of microorganisms (mycobacteria) in a sample by observing a change in fluorescence due to their metabolic activity. This is a common principle in in vitro diagnostic tests.
- Performance Studies: The document describes performance studies evaluating the device's ability to detect and recover mycobacteria from clinical specimens, comparing it to established reference methods. This type of evaluation is standard for IVD devices.
The core function of the device is to analyze a biological sample in vitro (outside the body) to provide information about a patient's health status (the presence of mycobacteria). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BBL® MGIT™ Mycobacteria Growth Indicator Tube and BBL® MGIT™ supplemented with BBL® MGIT™ OADC and BBL® MGIT™ supplemented with BBL® MGIT™ PANTA antibiotic, mixture, which provides greater recovery of mycobacteria. Acceptable is intended for the detection and recovery of mycobacterial clinical specimens (except urine) and sterile body fluids (except blood).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The BBL® MGIT™ Mycobacteria Growth Indicator Tube contains 4 mL of modified Middlebrook 7H9 Broth Base. The complete medium is supplemented with 0.5 mL OADC enrichment and 0.1 mL of PANTA antibiotic mixture, when necessary. The medium components are substances essential for the growth of mycobacteria. A fluorescent compound is embedded in the bottom of the BBL® MGIT™ tube which is sensitive to the presence of oxygen dissolved in the broth.
Specimens are inoculated (0.5 mL) into the BBL® MGIT™ tube and incubated at the appropriate temperature. Tubes are read daily from the second day of inoculation.
Actively respiring microorganisms consume the oxygen and allow the compound to fluoresce. Each inoculated BBL® MGIT™ tube is compared to the fluorescence Positive Control and Negative Control tube to assist in the interpretation of a positive signal from the BBL® MGIT™ tube.
A BBL® MGIT™ tube which exhibits fluorescence comparable to the Positive Control tube is considered presumptively positive for growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Internal testing of the BBL® MGIT™ tubes demonstrated the ability to recover a wide variety of mycobacterial species. Additionally, internal testing showed comparable recovery between the BACTEC® 460TB System and the BBL® MGIT™ tubes.
An external evaluation was performed at six (6) sites. Four (4) sites used the B&CTEC® 460TB System and conventional solid agar media as reference methods for comparison to the BBL® MGIT™ tubes. Two (2) sites used the BBL® SEPTI-CHEK® AFB Mycobacteria Culture System as the reference method for comparison to the BBL® MGIT™ tubes. A combined total of 2801 specimens were evaluated. The distribution of specimens tested by source was respiratory (78%), gastric (0.4%), body fluid (9.8%), tissue (7.0%), stool (2.5%) and other (2.4%). A total of 318 specimens were positive which represented 330 isolates recovered during the study.
Of these 330 isolates, 253 (77%) were recovered by the BBL® MGIT™ tubes, 260 (79%) were recovered by the BACTEC® 460TB System and the BBL® SEPTI-CHEK® AFB and 219 (66%) were recovered by conventional solid media. The average time-to-detection for the BBL® MGIT™ tubes for All mycobacteria was 14.1 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The BBL® MGIT™ tubes demonstrated a 0.5% false positive rate (MGIT fluorescent, no AFB present). The BBL® MGIT™ tubes failed to recover 3.7% of the isolates which were recovered in one or more of the reference systems (BACTEC ® 460TB, BBL® SEPTI-CHEK® AFB or conventional solid media). While this percentage represents a potential loss of recovery, it is not indicative of an actual false negative determination (refer to "Limitations of the Procedure" section). Use of a second medium, as recommended, will increase the probability of recovery of mycobacterial organisms. The average breakthrough contamination rate for the BBL® MGIT™ tubes was 9.7%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BACTEC® 460TB System, BBL® SEPTI-CHEK® AFB Mycobacteria Culture System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.2560 Microbial growth monitor.
(a)
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.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
0
Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, Maryland 21,152-0999 (410) 316-4000
Image /page/0/Picture/2 description: The image shows the words "BECTON DICKINSON" stacked on top of each other. The words are in a bold, sans-serif font and are black in color. The word "BECTON" is on the top line, and the word "DICKINSON" is on the bottom line. A line is drawn through the middle of the words.
510(k) SUMMARY
AUG 21 1996
BECTON DICKINSON MICROBIOLOGY SYSTEMS SUBMITTED BY: 7 Loveton Circle Sparks, MD 21152
Dennis R. Mertz, Manager of Regulatory Affairs CONTACT: (410)316-4099 TELEPHONE:
August 13, 1996 PREPARED:
BBL® MGIT™ Products TRADE NAME:
Selective Culture Medium COMMON NAME:
CLASSIFICATION Selective Culture Medium NAME:
BACTEC® 460TB System PREDICATE DEVICES: BACTEC 460TB System AFB Mycobacteria Culture System
The BBL® MGIT™ Mycobacteria Growth Indicator Tube INTENDED USE: The BBL MGTT™ Mycobaction Crown and BBL® MGIT™
supplemented with BBL® MGIT™ OADC and BBL® MGIT™ supplemented with BBL "IMST" - Greater is intended for PANTA antibiotic, mixture, whole provery of mycobacteria. Acceptable
the detection and recovery of mycobacterial clinical the detection and recovery of the seconaminated clinical specimen types are uigested and doesnament.
specimens (except urine) and sterile body fluids (except blood).
1
DEVICE DESCRIPTION:
The BBL® MGIT™ Mycobacteria Growth Indicator Tube contains 4 mL of modified Middlebrook 7H9 Broth Base. The complete medium is supplemented with 0.5 mL OADC enrichment and 0.1 mL of PANTA antibiotic mixture, when necessary. The medium components are substances essential for the growth of mycobacteria. A fluorescent compound is embedded in the bottom of the BBL® MGIT™ tube which is sensitive to the presence of oxygen dissolved in the broth.
Specimens are inoculated (0.5 mL) into the BBL® MGIT™ tube and incubated at the appropriate temperature. Tubes are read daily from the second day of inoculation.
Actively respiring microorganisms consume the oxygen and allow the compound to fluoresce. Each inoculated BBL® MGIT™ tube is compared to the fluorescence Positive Control and Negative Control tube to assist in the interpretation of a positive signal from the BBL® MGIT™ tube.
A BBL® MGIT™ tube which exhibits fluorescence comparable to the Positive Control tube is considered presumptively positive for growth.
2
DEVICE TECHNOLOGICAL CHARACTERISTICS:
Tables 1 & 2 summarize the similarities and differences between the BBL® MGIT™ tube and the predicate devices.
| BBL® MGIT™ | BACTEC® 460TB | |
|---|---|---|
| Intended Use | Growth and detection of mycobacteria from clinical specimens (excluding blood and urine). | Growth and detection of mycobacteria from clinical specimens. |
| Sample Type | Primary sample type - respiratory; other body fluids acceptable (excluding blood and urine). | Primary sample type - respiratory; other body fluids (excluding blood) acceptable. |
| Sample Volume | 0.5 mL | 0.5 - 1.0 mL |
| Reactive Ingredient | ||
| Concentrations of | ||
| Growth Medium | APPROX. COMPOSITION/1000 mL | APPROX. COMPOSITION/1000 mL |
| Na2HPO4 | ||
| L-Asparagine | ||
| KH2PO4 | ||
| Sodium glutamate | ||
| (NH4)2SO4 | ||
| Sodium citrate | ||
| MgSO4•7H2O | ||
| Ferric ammonium citrate | ||
| CuSO4•5H2O | ||
| Pyroxidine | ||
| ZnSO4•7H2O | ||
| Biotin | ||
| CaCl2•2H2O | ||
| Casein Peptone | ||
| Glycerol | Na2HPO4 | |
| KH2PO4 | ||
| Sodium glutamate | ||
| (NH4)2SO4 | ||
| Sodium citrate | ||
| MgSO4•7H2O | ||
| Ferric ammonium citrate | ||
| CuSO4•5H2O | ||
| Pyroxidine | ||
| ZnSO4•7H2O | ||
| Biotin | ||
| CaCl2•2H2O | ||
| Casein Hydrolysate | ||
| 2.5 g | ||
| 1.25 | ||
| 1.0 | ||
| 0.5 | ||
| 0.5 | ||
| 0.1 | ||
| 0.5 | ||
| 0.04 | ||
| 1.0 mg | ||
| 1.0 | ||
| 1.0 | ||
| 0.5 | ||
| 0.5 | ||
| 1.25 g | ||
| 3.1 mL | 2.5 g | |
| 1.0 | ||
| 0.5 | ||
| 0.5 | ||
| 0.1 | ||
| 0.05 | ||
| 0.04 | ||
| 1.0 mg | ||
| 1.0 | ||
| 1.0 | ||
| 0.5 | ||
| 0.5 | ||
| 0.1 g | ||
| Additional Medium | ||
| Growth Factors | BBL® MGIT™ OADC enrichment: | |
| Oleic Acid, Albumin, Dextrose, Catalase | Albumin, Catalase | |
| Detector | O2 sensitive fluorescent sensor in silicone rubber base. | 14C labeled fatty acid present in the medium. |
| Antimicrobial | ||
| Supplement | BBL® MGIT™ PANTA™ antibiotic mixture: | |
| Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin. | BACTEC® PANTA™ PLUS: | |
| Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin. | ||
| Growth Detection | Manual observation of fluorescence via excitation with longwave UV light. | |
| Fluorescence results from O2 consumption by mycobacterial growth. | Radiometric detection of 14CO2 liberated by mycobacterial growth. | |
| Incubation | ||
| Temperature | 37° C ± 1° C | 37° C ± 1° C |
Table 1: Comparison of BBL® MGIT™ to the BACTEC® 460TB System
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| BBL® MGITTM | BBL® SEPTI-CHEK® AFB | |
|---|---|---|
| Intended Use | Growth and detection of mycobacteria from clinical specimens. | Growth and detection of mycobacteria from clinical specimens. |
| Sample Type | Primary sample type - respiratory; other body fluids acceptable (excluding blood and urine). | Primary sample type - respiratory; other body fluids acceptable (excluding blood). |
| Sample Volume | 0.5 mL | 0.5 - 1.0 mL |
| Reactive Ingredient | ||
| Concentrations of | ||
| Growth Medium | APPROX. COMPOSITION/1000 mL | APPROX. COMPOSITION/1000 mL |
| Na2HPO4 | 2.5 g | 1.579 g |
| L-Asparagine | 1.25 | |
| KH2PO4 | 1.0 | 1.579 |
| Sodium glutamate | 0.5 | L-Glutamic acid 0.526 |
| (NH4)2SO4 | 0.5 | (NH4)2SO4 0.526 |
| Sodium citrate | 0.1 | Sodium citrate 0.421 |
| MgSO4•7H2O | 0.5 | MgSO2•7H2O 0.053 |
| Ferric ammonium citrate | 0.04 | Ferric ammonium citrate 0.042 |
| CuSO4•5H2O | 1.0 mg | |
| Pyroxidine | 1.0 | |
| ZnSO4•7H2O | 1.0 | |
| Biotin | 0.5 | Biotin 5.0 mg |
| CaCl2•2H2O | 0.5 | CaCl2•2H2O 0.5 |
| Casein Peptone | 1.25 g | Casein hydrolysate 1.053 g |
| Glycerol | 3.1 mL | |
| NaCl 0.895 | ||
| Malachite Green 1.0 mg | ||
| Additional Medium | ||
| Growth Factors | BBL® MGITTM OADC enrichment: | |
| Oleic Acid, Albumin, Dextrose, Catalase | BBL® SEPTI-CHEK® AFB Mycobacterial | |
| Culture Supplement: | ||
| Oleic Acid, Albumin, Dextrose, Catalase | ||
| Other Growth Media | ||
| as Part of System | None | BBL® SEPTI-CHEK® AFB Slide: |
| Middlebrook 7H11 Agar | ||
| Egg based agar medium | ||
| Chocolate Agar | ||
| Detector | O2 sensitive fluorescent sensor in silicone | |
| rubber base. | None | |
| Antimicrobial | ||
| Supplement | BBL® MGITTM PANTATM antibiotic mixture: | |
| Polymixin B, amphotericin B, nalidixic acid, | ||
| trimethoprim & azlocillin. | BBL® SEPTI-CHEK® AFB Mycobacterial | |
| Culture Supplement: | ||
| Polymixin B, amphotericin B, nalidixic acid, | ||
| trimethoprim & azlocillin. | ||
| Growth Detection | Manual observation of fluorescence via | |
| excitation with longwave UV light. | ||
| Fluorescence results from O2 consumption by | ||
| mycobacterial growth. | Macroscopic observance of growth on agar | |
| and/or in broth. | ||
| Incubation | ||
| Temperature | 37° C ± 1° C | 37° C ± 1° C |
Table 2: Comparison of BBL® MGIT™ to BBL® SEPTI-CHEK® AFB
4
4
SUMMARY OF DEVICE TESTING:
Internal testing of the BBL® MGIT™ tubes demonstrated the ability to recover a wide variety of mycobacterial species. Additionally, internal testing showed comparable recovery between the BACTEC® 460TB System and the BBL® MGIT™ tubes.
An external evaluation was performed at six (6) sites. Four (4) sites used the B&CTEC® 460TB System and conventional solid agar media as reference methods for comparison to the BBL® MGIT™ tubes. Two (2) sites used the BBL® SEPTI-CHEK® AFB Mycobacteria Culture System as the reference method for comparison to the BBL® MGIT™ tubes. A combined total of 2801 specimens were evaluated. The distribution of specimens tested by source was respiratory (78%), gastric (0.4%), body fluid (9.8%), tissue (7.0%), stool (2.5%) and other (2.4%). A total of 318 specimens were positive which represented 330 isolates recovered during the study
Of these 330 isolates, 253 (77%) were recovered by the BBL® MGIT™ tubes, 260 (79%) were recovered by the BACTEC® 460TB System and the BBL® SEPTI-CHEK® AFB and 219 (66%) were recovered by conventional solid media. The average time-to-detection for the BBL® MGIT™ tubes for All mycobacteria was 14.1 days. The BBL® MGIT™ tubes demonstrated a 0.5% false positive rate (MGIT fluorescent, no AFB present). The BBL® MGIT™ tubes failed to recover 3.7% of the isolates which were recovered in one or more of the reference systems (BACTEC ® 460TB, BBL® SEPTI-CHEK® AFB or conventional solid media). While this percentage represents a potential loss of recovery, it is not indicative of an actual false negative determination (refer to "Limitations of the Procedure" section). Use of a second medium, as recommended, will increase the probability of recovery of mycobacterial organisms. The average breakthrough contamination rate for the BBL® MGIT™ tubes was 9.7%.
CONCLUSIONS
Based on the internal and external evaluation of the BBL® MGIT™ tubes, the overall performance of the BBL® MGIT™ tubes is comparable to the BACTEC® 460TB System and the BBL® SEPTI-CHEK® AFB Mycobacterial Culture System; therefore, we believe the BBL® MGIT™ tube to be substantially equivalent to these devices.